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Publication: ZeOxaNMulti Trial: A Randomized, Double-Blinded, Placebo-Controlled Trial of Oral PMA-Zeolite to Prevent Chemotherapy-Induced Side Effects, in Particular, Peripheral Neuropathy + (Chemotherapy-induced peripheral neuropathy … Chemotherapy-induced peripheral neuropathy (CIPN) is the most frequently reported adverse effect of oxaliplatin. In this study, we set out to evaluate the role of the panaceo-micro-activation (PMA) zeolite in the reduction of the incidence of CIPN and hematological and liver toxicity. The possible impact of the PMA-zeolite as an adjuvant therapeutic agent is based on its detoxification properties toward agents promoting the development of neuropathy (e.g., ammonium - recognized as a neurotoxic agent produced by tumors), as well as its positive impact on immunity and oxidative stress through its effects in the gastrointestinal tract. From April 2015 to October 2018, a total of 120 patients (pts) diagnosed with predominantly colorectal cancer requiring oxaliplatin-based chemotherapy were randomized to receive either the PMA-zeolite (Multizeo Med) or placebo while undergoing oxaliplatin-based chemotherapy. A nerve-conduction study (NCS) was planned at the baseline, after three and six months of chemotherapy, to evaluate CIPN. Furthermore, the evaluation of hematological and liver toxicity was performed during every cycle of chemotherapy. 70.6% and 64.3% of patients developed CIPN in the placebo and the PMA-zeolite group, respectively. Patients treated with the PMA-zeolite were able to undergo more cycles of chemotherapy (p = 0.03), which also indicates a significant improvement in tolerance to the therapy. The group treated with the PMA-zeolite showed a lower CIPN (although not statistically significant within the whole group of subjects) compared to patients receiving placebo. This advantage was, however, statistically significant in men (p = 0.047). In addition, supplementation with the PMA-zeolite resulted in a lower incidence of severe-grade hematological toxicity (trend toward statistical significance of p = 0.09 was observed). Cancer patients may benefit from the therapy with the appropriate certified zeolite-products (e.g., the PMA-zeolite) for human use in CIPN. The lower CIPN (statistically significant results in the male subgroup) was accompanied by a trend of lower incidence of severe-grade hematological toxicity. Furthermore, these benefits led to a better tolerance toward chemotherapy (increase in cycles) and allow an improved compliance with the oncological treatment protocol.e with the oncological treatment protocol.)
Publication: Randomized, Double-Blind, Placebo-Controlled Trial of Polyphenon E in Prostate Cancer Patients before Prostatectomy: Evaluation of Potential Chemopreventive Activities + (Compelling preclinical and pilot clinical … Compelling preclinical and pilot clinical data support the role of green tea polyphenols in prostate cancer prevention. We conducted a randomized, double-blind, placebo-controlled trial of polyphenon E (enriched green tea polyphenol extract) in men with prostate cancer scheduled to undergo radical prostatectomy. The study aimed to determine the bioavailability of green tea polyphenols in prostate tissue and to measure its effects on systemic and tissue biomarkers of prostate cancer carcinogenesis. Participants received either polyphenon E (containing 800 mg epigallocatechin gallate) or placebo daily for 3 to 6 weeks before surgery. Following the intervention, green tea polyphenol levels in the prostatectomy tissue were low to undetectable. Polyphenon E intervention resulted in favorable but not statistically significant changes in serum prostate-specific antigen, serum insulin-like growth factor axis, and oxidative DNA damage in blood leukocytes. Tissue biomarkers of cell proliferation, apoptosis, and angiogenesis in the prostatectomy tissue did not differ between the treatment arms. The proportion of subjects who had a decrease in Gleason score between biopsy and surgical specimens was greater in those on polyphenon E but was not statistically significant. The study's findings of low bioavailability and/or bioaccumulation of green tea polyphenols in prostate tissue and statistically insignificant changes in systemic and tissue biomarkers from 3 to 6 weeks of administration suggests that prostate cancer preventive activity of green tea polyphenols, if occurring, may be through indirect means and/or that the activity may need to be evaluated with longer intervention durations, repeated dosing, or in patients at earlier stages of the disease.patients at earlier stages of the disease.)
Publication: Reflexology for symptom relief in patients with cancer. + (Complementary therapies are increasingly b … Complementary therapies are increasingly being used in hospices and hospitals alongside orthodox treatments in an attempt to improve patients’ emotional, spiritual, psychological, and physical well-being. An average of 31% of UK patients with cancer use some form of complementary therapy. Many UK cancer centers, out-patient units, and hospices are providing complementary services. There is strong anecdotal evidence that complementary therapies assist in the palliation of physical and psychological symptoms. This systematic review examines the research evidence base for the effectiveness of reflexology in cancer care. The study reports the results of a systematic review following the Cochrane principles of systematic reviewing. No meta-analysis was possible. Studies were retrieved from a comprehensive search of electronic databases from their start dates. An initial search was carried out in 2003 and updated in 2005 to 2006. Eligible studies were randomized controlled trials, controlled before and after studies, and interrupted time-series studies. Participants were adults with a diagnosis of cancer, receiving care in any healthcare setting. Interventions were limited to reflexology carried out by a qualified therapist as distinguished from another healthcare professional carrying out a reflexology intervention. Outcome measures were patient-reported levels of physical and psychological indices of symptom distress and quality of life (measured using validated assessment tools).easured using validated assessment tools).)
Publication: Comparative study among glutamine, acetyl-L-carnitine, vitamin-E and methylcobalamine for treatment of paclitaxel-induced peripheral neuropathy + (Context One of the major toxicities of pac … ContextOne of the major toxicities of paclitaxel is peripheral neuropathy, primarily affecting sensory components more than motor and autonomic functions. Acetyl-L-carnitine (ALC), methylcobalamine, vitamin E, and glutamine have been tested in various trials against placebos. This randomized study was conducted to compare the efficacy of these four drugs in relieving symptoms of paclitaxel-induced peripheral neuropathy.Settings and DesignThis single-institution, prospective, multi-arm, randomized study was conducted per the Helsinki protocol with local ethical committee clearances.Materials and MethodsPatients with carcinomas of the lung, breast, and ovary were recruited to receive paclitaxel 175 mg/m² intravenously as a 1st or 2nd line drug. They were randomized into one of four treatment arms: Arm A (vitamin E 400 mg OD from day 1 of the cycle to 1 month after completion of clinical trial [CT]); Arm B (ALC 250 mg OD from day 1 to day 7 in each cycle of CT); Arm C (glutamine 10 mg TDS from day 2 to day 5 in each cycle); and Arm D (methylcobalamine 500 μg TDS from day 1 of the first cycle to 1 month after completion of CT). All drugs were started at the onset of symptoms. CTCAE v 4.02 was used for assessments.Statistical Analysis UsedChanges in scores for sensory, motor, and pain symptoms over the study period were compared using repeated measures of the General Linear Model of SPSS version 17.ResultsA total of 22, 24, 21, and 23 patients were eligible for analysis in the four arms. Vitamin E produced comparable relief to methylcobalamine in alleviating peripheral neuropathy. Both vitamin E and methylcobalamine were superior to glutamine and ALC in relieving sensory, motor, and pain symptoms. Glutamine and ALC had comparable effects.ConclusionsAll four drugs were effective in alleviating symptoms, with vitamin E and methylcobalamine being more effective than glutamine and ALC in controlling symptoms of paclitaxel-induced peripheral neuropathy. paclitaxel-induced peripheral neuropathy.)
Publication: Effectiveness of Guarana (Paullinia cupana) for Postradiation Fatigue and Depression Results of a Pilot Double-Blind Randomized Study + (Context and objective: Guarana (Paullinia … Context and objective: Guarana (Paullinia cupana) has been used medicinally for centuries. The aim of this study is evaluate the effectiveness of guarana in the treatment of postradiation depression and fatigue.Design and setting: This study had a double-blind randomized design with crossover between experimental arms, at Faculdade de Medicina da Fundacao do ABC.Methods: We conducted a randomized double-blind crossover trial with 36 patients with breast cancer undergoing adjuvant radiation therapy. We randomized patients to either guarana 75 mg daily p.o. or to placebo. Patients were switched to the other experimental arm at the middle of the radiation treatment, which consisted of 28 daily fractions of 180 cGy. Evaluations were conducted at the beginning, at the middle, and at the end of radiation therapy.Results: We were unable to show any statistically significant differences between the guarana and the placebo- treated group with any of the measured scores. Also, within the same group, we did not see any statistically significant associations during either the guarana- or placebo-treated periods with any of the aforementioned measures.Conclusions: We were unable to show that patients with breast cancer undergoing radiation therapy derive any advantage with guarana over placebo for both fatigue and depressive symptoms. for both fatigue and depressive symptoms.)
Publication: Results of a Double-Blind, Randomized, Placebo-Controlled Study of Nabiximols Oromucosal Spray as an Adjunctive Therapy in Advanced Cancer Patients with Chronic Uncontrolled Pain + (Context: Prior Phase 2/3 studies found tha … Context: Prior Phase 2/3 studies found that cannabinoids might provide adjunctive analgesia in advanced cancer patients with uncontrolled pain.Objectives: To assess adjunctive nabiximols (Sativex), an extract of Cannabis sativa containing two potentially therapeutic cannabinoids (D9-tetrahydrocannabinol (27 mg/mL) and cannabidiol (25 mg/mL)), in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy.Methods: Phase 3, double-blind, randomized, placebo-controlled trial in patients with advanced cancer and average pain Numerical Rating Scale scores ≥4 and ≤8 despite optimized opioid therapy. Patients randomized to nabiximols (n = 199) or placebo (n ¼ 198) self-titrated study medications over a two-week period, followed by a three-week treatment period at the titrated dose.Results: Median percent improvements in average pain Numerical Rating Scale score from baseline to end of treatment in the nabiximols and placebo groups were 10.7% vs. 4.5% (P = 0.0854) in the intention-to-treat population (primary variable) and 15.5% vs. 6.3% (P = 0.0378) in the per-protocol population. Nabiximols was statistically superior to placebo on two of three quality-of-life instruments at Week 3 and on all three at Week 5. In exploratory post hoc analyses, U.S. patients, but not patients from the rest of the world, experienced significant benefits from nabiximols on multiple secondary endpoints. Possible contributing factors to differences in nabiximols efficacy include: 1) the U.S. participants received lower doses of opioids at baseline than the rest of the world and 2) the subgroups had different distribution of cancer pain types, which may have been related to differences in pathophysiology of pain. The safety profile of nabiximols was consistent with earlier studies.Conclusions: Although not superior to placebo on the primary efficacy endpoint, nabiximols had benefits on multiple secondary endpoints, particularly in the U.S. patients. Nabiximols might have utility in patients with advanced cancer who receive a lower opioid dose, such as individuals with early intolerance to opioid therapy. with early intolerance to opioid therapy.)
Publication: Effect of Curcumin Supplementation During Radiotherapy on Oxidative Status of Patients with Prostate Cancer: A Double Blinded, Randomized, Placebo-Controlled Study + (Curcumin is an antioxidant agent with both … Curcumin is an antioxidant agent with both radiosensitizing and radioprotective properties. The aim of the present study was to evaluate the effect of curcumin supplementation on oxidative status of patients with prostate cancer who undergo radiotherapy. Forty patients treated with radiotherapy for prostate cancer were randomized to the curcumin (CG, n = 20) or placebo group (PG, n = 20). They received curcumin (total 3 g/day) or placebo during external-beam radiation therapy of up to 74 Gy. Plasma total antioxidant capacity (TAC) and activity of superoxide dismutase (SOD), catalase, and glutathione peroxidase (GPx) were measured at baseline and 3 mo after radiotherapy completion. Analysis of covariance was used to compare the variables between groups following the intervention. Serum PSA levels and MRI/MRS images were investigated. In CG, TAC significantly increased (P < 0.001) and the activity of SOD decreased (P = 0.018) after radiotherapy compared with those at baseline. In CG, however, the activity of SOD had a significant reduction (P = 0.026) and TAC had a significant increase (P = 0.014) compared with those in PG. PSA levels were reduced to below 0.2 ng/ml in both groups, 3 mo after treatment, however, no significant differences were observed between the 2 groups regarding treatment outcomes.en the 2 groups regarding treatment outcomes.)
Publication: Die Therapie der radiogenen Mukositis mit Enzymen + (Die Strahlentherapie stellt eine wirksame … Die Strahlentherapie stellt eine wirksame Behandlungsvariante der Kopf-Halskarzinome dar. Dies sowohl als Teletherapie (prä- oder postoperativ) als auch in Form der sogenannten Brachytherapie wie z.B. die interstitielle Radiotherapie im „after loading“-Verfahren (siehe Kapitel „Radiotherapie von Kopf-Hals-Karzinomen“) „Radiotherapie von Kopf-Hals-Karzinomen“))
Publication: Effects of zinc supplementation on the survival of patients who received concomitant chemotherapy and radiotherapy for advanced nasopharyngeal carcinoma: follow-up of a double-blind randomized study with subgroup analysis + (Dietary zinc has been reported to have pos … Dietary zinc has been reported to have positive effects on treating carcinoma. This study examined the effects of zinc supplementation on the improved survival of patients with advanced nasopharyngeal carcinoma receiving concomitant chemotherapy and radiotherapy (CCRT). A double-blind, placebo-controlled clinical study with subgroup analysis. Thirty-four patients with stages III and IV nasopharyngeal carcinoma were selected from a double-blind, placebo-controlled clinical study. All the patients were randomized to receive a standard dose (75 mg/day for 2 months) of zinc supplements or placebo, in conjunction with CCRT. The overall local recurrence, metastasis, and disease-free survivals were defined as the period between the time of first treatment to the time of death, local recurrence, or distant metastases occurred. Patients in the experimental group exhibited a higher 5-year overall local-free and disease-free survival rate than the patients in the placebo group (p = .044, p = .007, and p = .033, respectively). However, no significant differences were found between both patient groups for the 5-year metastases-free survival rate (p = .149). Zinc supplementation prescribed in conjunction with CCRT effects attenuating local tumor recurrence and improves the overall survival of patients with advanced nasopharyngeal carcinoma. The failure to reduce distant metastasis survival might have been related in part to the more advanced disease stages in our patients.e advanced disease stages in our patients.)
Publication: Phase IB Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Women with Hormone Receptor–Negative Breast Cancer + (Epidemiologic data support an inverse asso … Epidemiologic data support an inverse association between green tea intake and breast cancer risk, and numerous experimental studies have shown the antitumor effects of its main component, epigallocatechingallate (EGCG). We conducted a phase IB dose escalation trial in women with a history of stage I to III hormone receptor–negative breast cancer of an oral green tea extract, polyphenon E (Poly E) 400, 600, 800 twice daily or matching placebo for 6 months. The primary endpoint was to determine the maximum tolerated dose (MTD), defined as the dose that causes 25% dose-limiting toxicity (DLT, grade II).Assignment to dose level was based upon an adaptive design, the continual reassessment method. A mammogram and random core biopsy of the contralateral breast were obtained at baseline and 6 months and serial blood/urine collections every 2 months for biomarker analyses. Forty women were randomized: 10 to placebo, 30 to Poly E (16 at 400 mg, 11 at 600 mg, 3 at 800 mg). There was one DLT at 400mg(grade III rectal bleeding), three DLTs at 600 mg (grade II weight gain, grade III indigestion and insomnia), and one DLT at 800 mg (grade III liver function abnormality). The DLT rate at 600 mg was 27% (3 of 11). Pharmacologic levels of total urinary tea polyphenols were achieved with all three dose levels of Poly E. Using a novel phase I trial design, we determined the MTD for Poly E to be 600 mg twice daily. This study highlights the importance of assessing toxicity for any chemopreventive agent being developed for chronic use in healthy individuals.ed for chronic use in healthy individuals.)
Publication: Effects of Reflexotherapy on Acute Postoperative Pain and Anxiety Among Patients With Digestive Cancer. + (Even after receiving analgesia, patients w … Even after receiving analgesia, patients with gastric and liver cancer still report moderate levels of postoperative pain. The purpose of the study was to investigate the efficacy of foot reflexotherapy as adjuvant therapy in relieving pain and anxiety in postoperative patients with gastric cancer and hepatocellular cancer. The study design was a randomized controlled trial. Data were collected from 4 surgical wards of a medical center in 2005 in Taipei, Taiwan. Sixty-one patients who had received surgery for gastric cancer or hepatocellular carcinoma were randomly allocated to an intervention (n = 30) or control (n = 31) arm. Patients in the intervention arm received the usual pain management plus 20 minutes of foot reflexotherapy during postoperative days 2, 3, and 4. Patients in the control arm received usual pain management.Outcome measures included the short-form McGill Pain Questionnaire, visual analog scale for pain, summary of the pain medications consumed, and the Hospital Anxiety and Depression Scale. Results demonstrated that studied patients reported moderately high levels of pain and anxiety postoperatively while patients were managed with patient-controlled analgesia. Using generalized estimation equations and controlling for confounding variables, less pain (P < .05) and anxiety (P < .05) over time were reported by the intervention arm compared with the control arm. In addition, patients in the intervention arm received significantly less opioid analgesics than the control arm (P < .05). Findings from this study provide nurses with an additional treatment to offer postoperative digestive cancer patients.t to offer postoperative digestive cancer patients.)
Publication: Placebo-Controlled, Double-Blind, Randomized Study of a Dry Guarana Extract in Patients with Head and Neck Tumors Undergoing Chemoradiotherapy: Effects on Fatigue and Quality of Life + (Fatigue is a common symptom in patients wi … Fatigue is a common symptom in patients with head and neck carcinoma who undergo chemoradiotherapy. Guarana (Paullinia cupana) is a plant that grows in the Brazilian Amazon region that was used previously to treat fatigue induced by chemotherapy. Methods: In this phase II prospective study, we evaluated 60 patients with stage I–IV head and neck squamous cell carcinoma before, during, and after chemoradiotherapy. The patients were randomized into two arms: placebo versus guarana at a dose of 50 mg twice a day during the chemoradiotherapy treatment. We used the FACT-HN, EORTC-HN35, and EORTC-Q30 questionnaires to assess fatigue and quality of life (QOL). Results: A significant worsening of QOL in the overall (p = 0.0054), functional (p = 0.018), and symptom (p = 0.0042) domains after the second cycle of chemotherapy was observed in patients using guarana compared to the placebo group. No significant differences in any QOL domain for either the guarana or placebo group were observed when the first and the fourth evaluations of each domain in each group were compared. Regarding the FACT-HN35 questionnaire, the guarana group showed improvement after the first cycle of chemoradiotherapy with respect to pain (p = 0.0133), social eating (p = 0.0227), swallowing (p = 0.0254), coughing (p = 0.0107), and weight loss (p = 0.012); however, after treatment completion (after the third cycle) weight loss worsened (p = 0.0074) and greater use of a nasogastric tube (p = 0.051), in addition to increased use of analgesics (p = 0.0253), was observed in the guarana group. Regarding the EORTC-QOL C30 questionnaire, improvement of symptoms in the three domains (functional, overall, and symptoms) was observed in patients using guarana. No significant difference was observed between the groups regarding toxicity as graded by the Common Terminology Criteria for Adverse Events (CTCAE) scale. Conclusion: We propose that guarana is not beneficial for this patient population.ot beneficial for this patient population.)
Publication: Placebo-Controlled, Double-Blind, Randomized Study of a Dry Guarana Extract in Patients with Head and Neck Tumours Undergoing Chemoradiotherapy: Effects on Fatigue and Quality of Life + (Fatigue is a common symptom in patients wi … Fatigue is a common symptom in patients with head and neck carci- noma who undergo chemoradiotherapy. Guarana (Paullinia cupana) is a plant that grows in the Brazilian Amazon region that was used previously to treat fatigue induced by chemotherapy.Methods: In this phase II prospective study, we evaluated 60 patients with stage I–IV head and neck squamous cell carcinoma before, during, and after chemoradiotherapy. The patients were randomized into two arms: placebo versus guarana at a dose of 50 mg twice a day during the chemoradiotherapy treatment. We used the FACT-HN, EORTC-HN35, and EORTC-Q30 questionnaires to assess fa- tigue and quality of life (QOL). Results: A significant worsening of QOL in the overall (p = 0.0054), functional (p = 0.018), and symptom (p = 0.0042) domains after the second cycle of chemotherapy was observed in patients using guarana compared to the placebo group. No significant differences in any QOL domain for either the guarana or placebo group were observed when the first and the fourth evaluations of each domain in each group were compared. Regarding the FACT-HN35 questionnaire, the guarana group showed improvement after the first cycle of chemoradiotherapy with respect to pain (p = 0.0133), social eating (p = 0.0227), swallowing (p = 0.0254), coughing (p = 0.0107), and weight loss (p = 0.012); however, after treatment completion (after the third cycle) weight loss worsened (p = 0.0074) and greater use of a nasogastric tube (p = 0.051), in addition to increased use of analgesics (p = 0.0253), was observed in the guarana group. Regarding the EORTC-QOL C30 questionnaire, improvement of symptoms in the three domains (functional, overall, and symptoms) was observed in patients using guarana. No significant difference was observed between the groups regarding toxicity as graded by the Common Terminology Criteria for Adverse Events (CTCAE) scale. Conclusion: We propose that guarana is not beneficial for this patient population.ot beneficial for this patient population.)
Publication: The Effect of a Standardized Ginger Extract on Chemotherapy-Induced Nausea-Related Quality of Life in Patients Undergoing Moderately or Highly Emetogenic Chemotherapy: A Double Blind, Randomized, Placebo Controlled Trial + (Ginger supplementation could be an effecti … Ginger supplementation could be an effective adjuvant treatment for chemotherapy-induced nausea (CIN). The aim of this clinical trial was to address significant methodological limitations in previous trials. Patients (N = 51) were randomly allocated to receive either 1.2 g of standardised ginger extract or placebo per day, in addition to standard anti-emetic therapy, during the first three cycles of chemotherapy. The primary outcome was CIN-related quality of life (QoL) measured with the Functional Living Index- Emesis (FLIE) questionnaire. Secondary outcomes included acute and delayed nausea, vomiting, and retching as well as cancer-related fatigue, nutritional status, and CIN and vomiting-specific prognostic factors. Over three consecutive chemotherapy cycles, nausea was more prevalent than vomiting (47% vs. 12%). In chemotherapy Cycle 1, intervention participants reported significantly better QoL related to CIN (p = 0.029), chemotherapy-induced nausea and vomiting (CINV)-related QoL (p = 0.043), global QoL (p = 0.015) and less fatigue (p = 0.006) than placebo participants. There were no significant results in Cycle 2. In Cycle 3, global QoL (p = 0.040) and fatigue (p = 0.013) were significantly better in the intervention group compared to placebo. This trial suggests adjuvant ginger supplementation is associated with better chemotherapy-induced nausea-related quality of life and less cancer-related fatigue, with no difference in adverse effects compared to placebo.ce in adverse effects compared to placebo.)
Publication: Evaluating the Effect of Zingiber Officinalis on Nausea and Vomiting in Patients Receiving Cisplatin Based Regimens + (Ginger, the rhizome of Zingiber officinali … Ginger, the rhizome of Zingiber officinalis, has long been used as herbal medicine for its antiemetic effect. For evaluating the effect of zingiber officinalis on nausea and vomiting (N and V) in patients receiving cisplatin based regimens, a randomized double-blind placebo-controlled cross-over clinical trial was carried out in patients receiving cisplatin in combination with other chemotherapeutic agents. The patients were randomly assigned to receive ginger capsules (rhizome of zingiber officinalis) or placebo in their first cycle of the study. All patients received standard antiemetics for chemotherapy induced nausea and vomiting (CINV). The patients were crossed-over to receive ginger or placebo in their next cycle of chemotherapy. Among 36 eligible patients who received both cycles of treatment, there were no difference in prevalence, severity, and duration of both acute and delayed N and V. Addition of ginger to the standard antiemetic regimen has shown no advantage in reducing acute and delayed N and V in patients with cisplatin-based regimen in this study.ith cisplatin-based regimen in this study.)
Publication: Phase II trial of encapsulated ginger as a treatment for chemotherapy-induced nausea and vomiting + (Goals of work Ginger has been used to trea … Goals of work Ginger has been used to treat numerous types of nausea and vomiting. Ginger has also been studied for its efficacy for acute chemotherapy-induced nausea and vomiting (CINV). However, its efficacy for delayed CINV in a diverse oncology population is unknown.Materials and methods We performed a randomized, double-blind, placebo-controlled trial in 162 patients with cancer who were receiving chemotherapy and had experienced CINV during at least one previous round of chemotherapy. All participants were receiving a 5-HT3 receptor antagonists and/or aprepitant. Participants were randomized to receive either 1.0 g ginger, 2.0 g ginger daily, or matching placebo for 3 days. The primary outcome was change in the prevalence of delayed CINV. Secondary outcomes included acute prevalence of CINV, acute and delayed severity of CINV, and assessment of blinding. Main results There were no differences between groups in the prevalence of delayed nausea or vomiting, prevalence of acute CINV, or severity of delayed vomiting or acute nausea and vomiting. Participants who took both ginger and aprepitant had more severe acute nausea than participants who took only aprepitant. Participants were able to accurately guess which treatment they had received. Ginger appeared well tolerated, with no difference in all adverse events (AEs) and significantly less fatigue and miscellaneous AEs in the ginger group.Conclusions Ginger provides no additional benefit for reduction of the prevalence or severity of acute or delayed CINV when given with 5-HT3 receptor antagonists and/or aprepitant.T3 receptor antagonists and/or aprepitant.)
Publication: Effect of High-Dose vs Standard-Dose Vitamin D3 Supplementation on Progression-Free Survival Among Patients With Advanced or Metastatic Colorectal Cancer: The SUNSHINE Randomized Clinical Trial + (IMPORTANCE: In observational studies, high … IMPORTANCE: In observational studies, higher plasma 25-hydroxyvitamin D (25[OH]D) levels have been associated with improved survival in metastatic colorectal cancer (CRC).OBJECTIVE: To determine if high-dose vitamin D3 added to standard chemotherapy improves outcomes in patients with metastatic CRC.DESIGN, SETTING, AND PARTICIPANTS: Double-blind phase 2 randomized clinical trial of 139 patients with advanced or metastatic CRC conducted at 11 US academic and community cancer centers from March 2012 through November 2016 (database lock: September 2018).INTERVENTIONS: mFOLFOX6 plus bevacizumab chemotherapy every 2 weeks and either high-dose vitamin D3 (n = 69) or standard-dose vitamin D3 (n = 70) daily until disease progression, intolerable toxicity, or withdrawal of consent.MAIN OUTCOMES AND MEASURES: The primary endpoint was progression-free survival (PFS) assessed by the log-rank test and a supportive Cox proportional hazards model. Testing was 1-sided. Secondary end points included tumor objective response rate (ORR), overall survival (OS), and change in plasma 25(OH)D level.RESULTS: Among 139 patients(mean age, 56 years; 60 (43%) women) who completed or discontinued chemotherapy and vitamin D3 (median follow-up, 22.9 months), the median PFS for high-dose vitamin D3 was 13.0 months (95% CI, 10.1 to 14.7; 49 PFS events) vs 11.0 months (95% CI, 9.5 to 14.0; 62 PFS events) for standard dose vitamin D3 (log-rank P = .07); multivariable hazard ratio for PFS or death was 0.64 (1-sided 95% CI, 0 to 0.90; P = .02). There were no significant differences between high-dose and standard-dose vitamin D3 for tumor ORR (58% vs 63%, respectively; difference, −5% (95% CI, −20% to 100%]), P = .27) or OS (median, 24.3 months vs 24.3 months; log-rank P = .43). The median 25(OH)D level at baseline for high-dose vitamin D3 was 16.1 ng/mL vs 18.7 ng/mL for standard-dose vitamin D3 (difference, −2.6 ng/mL (95% CI, −6.6 to 1.4), P = .30); at first restaging, 32.0 ng/mL vs 18.7 ng/mL (difference, 12.8 ng/mL (95% CI, 9.0 to 16.6), P < .001); at second restaging, 35.2 ng/mL vs 18.5 ng/mL (difference, 16.7 ng/mL (95% CI, 10.9 to 22.5), P < .001); and at treatment discontinuation, 34.8 ng/mL vs 18.7 ng/mL (difference, 16.2 ng/mL (95% CI, 9.9 to 22.4), P < .001). The most common grade 3 and higher adverse events for chemotherapy plus high-dose vs standard-dose vitamin D3 were neutropenia (n = 24 (35%) vs n = 21 (31%), respectively) and hypertension (n = 9 (13%) vs n = 11 (16%)).CONCLUSIONS AND RELEVANCE: Among patients with metastatic CRC, addition of high-dose vitamin D3, vs standard dose vitamin D3, to standard chemotherapy resulted in a difference in median PFS that was not statistically significant, but with a significantly improved supportive hazard ratio. These findings warrant further evaluation in a larger multicenter randomized clinical trial.ficantly improved supportive hazard ratio. These findings warrant further evaluation in a larger multicenter randomized clinical trial.)
Publication: Predictors of hand-foot syndrome and pyridoxine for prevention of capecitabine-induced hand-foot syndrome: a randomized clinical trial + (Importance: Hand-foot syndrome (HFS) is a … Importance: Hand-foot syndrome (HFS) is a common adverse effect of capecitabine treatment.Objective: To compare the incidence and time to onset of grade 2 or greater HFS in patients receiving pyridoxine vs placebo and to identify biomarkers predictive of HFS. Design, Setting, and Participants: This single-center, randomized double-blind, placebo-controlled phase 3 trial conducted at National Cancer Centre Singapore assessed whether oral pyridoxine could prevent the onset of grade 2 or higher HFS in 210 patients scheduled to receive single-agent capecitabine chemotherapy for breast, colorectal, and other cancers.Interventions: Patients were randomized to receive concurrent pyridoxine (200 mg) or placebo daily for a maximum of 8 cycles of capecitabine, with stratification by sex and use in adjuvant or neoadjuvant vs palliative setting. Patients were withdrawn from the study on development of grade 2 or higher HFS or cessation of capecitabine. Main Outcomes and Measures Primary end point was the incidence of grade 2 or higher HFS in patients receiving pyridoxine. Secondary end points included the time to onset (days) of grade 2 or higher HFS and identification of biomarkers predictive of HFS, including baseline folate and vitamin B12 levels, as well as genetic polymorphisms with genome-wide arrays.Results: In this cohort of 210 patients (median (range) age, 58 (26-82) years; 162 women) grade 2 or higher HFS occurred in 33 patients (31.4%) in the pyridoxine arm vs 39 patients (37.1%) in the placebo arm (P = .38). The median time to onset of grade 2 or higher HFS was not reached in both arms. In univariate analysis, the starting dose of capecitabine (odds ratio (OR), 1.99; 95% CI, 1.32-3.00; P = .001), serum folate levels (OR, 1.27; 95% CI, 1.10-1.47; P = .001), and red blood cell folate levels (OR, 1.25; 95% CI, 1.08-1.44; P = .003) were associated with increased risk of grade 2 or higher HFS. In multivariate analyses, serum folate (OR, 1.30; 95% CI, 1.12-1.52; P < .001) and red blood cell folate (OR, 1.28; 95% CI, 1.10-1.49; P = .001) were the only significant predictors of grade 2 or higher HFS. Grade 2 or higher HFS was associated with 300 DNA variants at genome-wide significance (P < 5 × 10−8), including a novel DPYD variant (rs75267292; P = 1.57 × 10−10), and variants in the MACF1 (rs183324967, P = 4.80 × 10−11; rs148221738, P = 5.73 × 10−10) and SPRY2 (rs117876855, P < 1.01 × 10−8; rs139544515, P = 1.30 × 10−8) genes involved in wound healing.Conclusions and Relevance: Pyridoxine did not significantly prevent or delay the onset of grade 2 or higher HFS. Serum and red blood cell folate levels are independent predictors of HFS.ll folate levels are independent predictors of HFS.)
Publication: Effect of Vitamin D Supplementation on Relapse-Free Survival Among Patients With Digestive Tract Cancers The AMATERASU Randomized Clinical Trial + (Importance: Randomized clinical trials of … Importance: Randomized clinical trials of vitamin D supplementation for secondary prevention in patients with cancer are needed, given positive results of observational studies.Objective: To determine whether postoperative vitamin D3 supplementation can improve survival of patients with digestive tract cancers overall and in subgroups stratified by 25-hydroxyvitamin D (25[OH]D) levels.Design, Setting, and Participants: The AMATERASU trial, a randomized, double-blind, placebo-controlled trial conducted at a single university hospital in Japan. Enrollment began in January 2010 and follow-up was completed in February 2018. Patients aged 30 to 90 years with cancers of the digestive tract from the esophagus to the rectum, stages I to III, were recruited. Of 439 eligible patients, 15 declined and 7 were excluded after operation.Interventions: Patients were randomized to receive oral supplemental capsules of vitamin D (2000 IU/d; n = 251) or placebo (n = 166) from the first postoperative outpatient visit to until the end of the trial.Main Outcomes and Measures: The primary outcome was relapse-free survival time to relapse or death. The secondary outcome was overall survival time to death due to any cause. Subgroups analyzed had baseline serum 25(OH)D levels of 0 to less than 20 ng/mL, 20 to 40 ng/mL, and greater than 40 ng/mL; because of small sample size for the highest-baseline-level group, interactions were tested only between the low- and middle-baseline-level groups.Results: All 417 randomized patients (mean age, 66 years; male, 66%; esophageal cancer, 10%; gastric cancer, 42%; colorectal cancer, 48%) were included in the analyses. There was 99.8% follow-up over a median 3.5 (interquartile range, 2.3-5.3) years, with maximal follow-up of 7.6 years. Relapse or death occurred in 50 patients (20%) randomized to vitamin D and 43 patients (26%) randomized to placebo. Death occurred in 37 (15%) in the vitamin D group and 25 (15%) in the placebo group. The 5-year relapse-free survival was 77% with vitamin D vs 69% with placebo (hazard ratio [HR] for relapse or death, 0.76; 95% CI, 0.50-1.14; P = .18). The 5-year overall survival in the vitamin D vs placebo groups was 82% vs 81% (HR for death, 0.95; 95% CI, 0.57-1.57; P = .83). In the subgroup of patients with baseline serum 25(OH)D levels between 20 and 40 ng/mL, the 5-year relapse-free survival was 85% with vitamin D vs 71% with placebo (HR for relapse or death, 0.46; 95% CI, 0.24-0.86; P = .02; P = .04 for interaction). Fractures occurred in 3 patients (1.3%) in the vitamin D group and 5 (3.4%) in the placebo group. Urinary stones occurred in 2 patients (0.9%) in the vitamin D group and 0 in the placebo group.Conclusions and Relevance: Among patients with digestive tract cancer, vitamin D supplementation, compared with placebo, did not result in significant improvement in relapse-free survival at 5 years.ement in relapse-free survival at 5 years.)
Publication: Strahlentherapeutische Nebenwirkungen bei Abdominalkrebspatienten und deren Reduktion durch hydrolytische Enzyme + (In this randomized prospective clinical tr … In this randomized prospective clinical trial hydrolytic enzymes were given addionally to radiation in abdominal cancer patients and compared with radiation only. The concomitant oral enzyme therapy improved the tolerance of the radiation significantly. The enzyme treated patients had less deterioration of general condition and skin symptomes and less patients discontinued radiation. It reduced the number of drugs needed for the treatment od radiation avderse effects, especially antiemetics, gastrointestinal drugs, antidepressives, tranquilizers and other psychopharmaceuticals, analgetics, spamolytics, diuretics and aldosteron antagonists. In most cases the enzyme therapy was well or very well tolerated.e therapy was well or very well tolerated.)
Publication: Influence of vitamin C on salivary absorbed dose of 131I in thyroid cancer patients: a prospective, randomized, single-blind, controlled trial + (In this study, vitamin C was administered … In this study, vitamin C was administered at various times as a sour stimulant to thyroid cancer patients, and the effect on salivary absorbed dose of therapeutic radioiodine (131I) was investigated.Methods: Patients with differentiated thyroid cancer who had been prepared for thyroid remnant ablation after total thyroidectomy were prospectively recruited and, using a random-number table, were divided into 4 groups. In the hypothyroid condition, the patients in groups A, B, C, and D began sucking vitamin C (100 mg every 4 h in the daytime over 6 d) at 1, 5, 13, and 25 h, respectively, after receiving 3.7 GBq of (131)I. Scintigraphic images of the head and neck were serially acquired after (131)I administration to assess biokinetics in the salivary glands. Calculation of salivary absorbed dose was based on the MIRD schema of the Society of Nuclear Medicine.Results: Seventy-two patients (18, 18, 19, and 17 patients from groups A, B, C, and D, respectively) were eligible for the analysis of salivary dosimetry. Differences in absorbed doses to the parotid salivary gland (0.18 +/- 0.11, 0.16 +/- 0.07, 0.16 +/- 0.09, and 0.16 +/- 0.12 mGy/MBq in groups A, B, C, and D, respectively; P = 0.37) and submandibular salivary gland (0.19 +/- 0.05, 0.17 +/- 0.05, 0.18 +/- 0.07, and 0.17 +/- 0.06 mGy/MBq, respectively; P = 0.28) were not statistically significant among groups. Salivary cumulated activities arising from the first 24 h after (131)I administration accounted for 86.08% +/- 7.89% (range, 75%-98%) of total cumulated activities. Differences in salivary absorbed dose during the first 24 h were not statistically significant among the 4 groups either (P = 0.32 and 0.24, respectively, for the parotid and submandibular salivary glands).Conclusion: Salivary stimulation with vitamin C at any time after (131)I administration has only a limited effect on salivary absorbed dose in thyroid cancer patients. absorbed dose in thyroid cancer patients.)
Publication: A Randomized Controlled Trial of a 6-month low carbohydrate intervention on disease progression in men with recurrent prostate cancer: Carbohydrate and Prostate Study 2 (CAPS2) + (Introduction: Both weight loss and low car … Introduction: Both weight loss and low carbohydrate diets (LCD) without weight loss prolong survival in prostate cancer (PC) models. Few human trials tested weight loss or LCD on PC. Methods: We conducted a multi-site randomized 6-month trial of LCD vs control on PSA doubling time (PSADT) in PC patients with biochemical recurrence (BCR) after local treatment. Eligibility included BMI ≥24 kg/m2 and PSADT 3-36 months. LCD was instructed to eat ≤20g/carbs/day; controls were instructed to avoid dietary changes. Primary outcome was PSADT. Secondary outcomes included weight, lipids, glucose metabolism, and diet. Results: Of 60 planned patients, the study stopped early after an interim analysis showed futility. 27 LCD and 18 controls completed the study. At 6-month, while both arms consumed similar protein and fats, LCD reduced carbohydrates intake (-117 vs. 8g, p<0.001) and lost weight (-12.1 vs. -0.50Kg, p<0.001). LCD reduced HDL, triglycerides, and HbA1c with no difference in total cholesterol or glucose. Mean PSADT was similar between LCD (21 months) vs. control (15 months, p=0.316). In a post-hoc exploratory analysis accounting for pre-study PSADT, baseline PSA, primary treatment and hemoconcentration, PSADT was significantly longer in LCD vs. controls (28 vs 13 months, p=0.021). Adverse events were few, usually mild, and returned to baseline by 6-month.Conclusions: Among BCR patients, LCD induced weight loss and metabolic benefits with acceptable safety without affecting PSADT suggesting LCD does not adversely affect PC growth and is safe. Given exploratory findings of longer PSADT, larger studies testing LCD on disease progression are warranted.esting LCD on disease progression are warranted.)
Publication: High-dose zinc oral supplementation after stem cell transplantation causes an increase of TRECs and CD4+ naive lymphocytes and prevents TTV reactivation + (Introduction: Zinc plays an important role … Introduction: Zinc plays an important role in thymic function and immune homeostasis. We performed a pro- spective clinical trial using a high-dose zinc oral supplementation to improve the immune reconstitution after hematopoietic stem cell transplant (HSCT). Patients and methods: We enrolled 18 patients undergoing autologous HSCT for multiple myeloma. Nine patients were randomized to receive only a standard antimicrobial prophylaxis; whereas, nine patients received in ad- dition 150 mg/day of zinc from day +5 to day +100 after transplant.Results: CD4+ naïve lymphocytes and TRECs showed a significant increase from day +30 until day +100 only in the zinc-treated group. Moreover, the load of Torquetenovirus, a harmless virus that replicates in course of immunedepression, increased at day +100 only in the control group. No severe adverse events were reported during the zinc consumption.Conclusion: First data from the ZENITH trial suggest that high-dose zinc supplementation is safe and may en- hance the thymic reconstitution after HSCT.ance the thymic reconstitution after HSCT.)
Publication: Three-arm randomized phase III trial: Quality aloe and placebo cream versus powder as skin treatment during breast cancer radiation therapy + (It has been proposed that aloe cream could … It has been proposed that aloe cream could reduce the severity of skin toxicity from radiation therapy for breast cancer. The present 3-arm study compared control powder with double-blind aloe or placebo cream and found that the patients who had used dry powder skin care during radiation therapy had a lower severity of skin toxicity than that of the patients who had used either the placebo or aloe cream. We recommend a dry powderregimen during radiation therapy to reduce the severity of skin toxicity. Background: The efficacy of aloe extract in reducing radiation-induced skin injury is controversial. The purpose of the present 3-arm randomized trial was to test the efficacy of quality-tested aloe extract in reducing the severity of radiation-induced skin injury and, secondarily, to examine the effect of a moist cream versus a dry powder skin care regimen. Materials and Methods: A total of 248 patients with breast cancer were randomized to powder, aloe cream,or placebo cream. Acute skin toxicity was scored weekly and after treatment at weeks 1, 2, and 4 using a modified 10-point Catterall scale. The patients scored their symptom severity using a 6-point Likert scale and kept an acute phase diary. Results: The aloe formulation did not reduce acute skin toxicity or symptom severity. Patients with a greater body mass index were more likely to develop acute skin toxicity. A similar pattern of increased skin reaction toxicity occurred with both study creams compared with the dry powder regimen. Conclusion: No evidence was found to support prophylactic application of quality aloe extract or cream to improve the symptoms or reduce the skin reaction severity. Our results support a dry skin care regimen of powder during radiation therapy.egimen of powder during radiation therapy.)
Publication: Favorable Effects of a Ketogenic Diet on Physical Function, Perceived Energy, and Food Cravings in Women with Ovarian or Endometrial Cancer: A Randomized, Controlled Trial + (Ketogenic diets (KDs) are gaining attentio … Ketogenic diets (KDs) are gaining attention as a potential adjuvant therapy for cancer, but data are limited for KDs’ effects on quality of life. We hypothesized that the KD would (1) improve mental and physical function, including energy levels, (2) reduce hunger, and (3) diminish sweet and starchy food cravings in women with ovarian or endometrial cancer. Participants were randomized to a KD (70:25:5 energy from fat, protein, and carbohydrate) or the American Cancer Society diet (ACS: high-fiber, lower-fat). Questionnaires were administered at baseline and after 12 weeks on the assigned diet to assess changes in mental and physical health, perceived energy, appetite, and food cravings. We assessed both between-group differences and within-group changes using ANCOVA and paired t-tests, respectively. After 12 weeks, there was a significant between-group difference in adjusted physical function scores (p < 0.05), and KD participants not receiving chemotherapy reported a significant within-group reduction in fatigue (p < 0.05). There were no significant between-group differences in mental function, hunger, or appetite. There was a significant between-group difference in adjusted cravings for starchy foods and fast food fats at 12 weeks (p < 0.05 for both), with the KD group demonstrating less frequent cravings than the ACS. In conclusion, in women with ovarian or endometrial cancer, a KD does not negatively affect quality of life and in fact may improve physical function, increase energy, and diminish specific food cravings. This trial was registered at ClinicalTrials.gov as NCT03171506.as registered at ClinicalTrials.gov as NCT03171506.)

Publication: Unterstützung der Chemotherapie inoperabler Karzinome durch proteolytische Fermente + (NI)

Publication: Efficacy of Ginger in Ameliorating Acute and Delayed Chemotherapy-Induced Nausea and Vomiting Among Patients With Lung Cancer Receiving Cisplatin-Based Regimens: A Randomized Controlled Trial + (Nausea and vomiting are among the most com … Nausea and vomiting are among the most common and distressing side effects of chemotherapy. Additional antiemetic drugs are urgently needed to effectively manage and ameliorate chemotherapy-induced nausea and vomiting (CINV). The efficacy of ginger as an antiemetic modality for ameliorating CINV has not been established in previous studies. The aim ofmthis study was to examine the efficacy of ginger, as an adjuvant drug to standard antiemetic therapy, in ameliorating acute and delayed CINV in patients with lung cancer receiving cisplatin-based regimens. In this randomized, double-blind, placebo-controlled clinical trial, 140 patients with lung cancer receiving cisplatin-based regimens were enrolled and allocated to receive either ginger root powder or a placebo. Ginger root powder was administered orally (0.5 g, 2 capsules per day, 0.25 g per capsule, every 12 hours) for 5 days beginning on the first day of chemotherapy. The incidence and severity of acute and delayed nausea and vomiting were assessed using the MASCC (Multinational Association of Supportive Care in Cancer) Antiemesis Tool (MAT). Adverse effects and patient adherence were also assessed in this study. No significant difference was observed between the ginger and control groups in the reduction of the incidence and severity of nausea and vomiting (P > .05). No significant difference in adverse events was observed between the 2 groups (P > .05). No study-treatment-related adverse events were observed in this study. As an adjuvant drug to standard antiemetic therapy, ginger had no additional efficacy in ameliorating CINV in patients with lung cancer receiving cisplatin-based regimens. lung cancer receiving cisplatin-based regimens.)
Publication: Efficacy of Ginger in Control of Chemotherapy Induced Nausea and Vomiting in Breast Cancer Patients Receiving Doxorubicin- Based Chemotherapy + (Nausea and vomiting are among the most ser … Nausea and vomiting are among the most serious side effects of chemotherapy, in some cases leading to treatment interruption or chemotherapy dose reduction. Ginger has long been known as an antiemetic drug, used for conditions such as motion sickness, nausea-vomiting in pregnancy, and post-operation side effects. One hundred and fifty female patients with breast cancer entered this prospective study and were randomized to receive ginger (500 mg ginger powder, twice a day for 3 days) or placebo. One hundred and nineteen patients completed the study: 57 of them received ginger and 62 received ginger for the first 3 chemotherapy cycles. Mean age in all patients was 48.6 (25-79) years. After 1st chemotherapy, mean nausea in the ginger and control arms were 1.36 (±1.31) and 1.46 (±1.28) with no statistically significant difference. After the 2nd chemotherapy session, nausea score was slightly more in the ginger group (1.36 versus 1.32). After 3rd chemotherapy, mean nausea severity in control group was less than ginger group [1.37 (±1.14), versus 1.42 (±1.30)]. Considering all patients, nausea was slightly more severe in ginger arm. In ginger arm mean nausea score was 1.42 (±0.96) and in control arm it was 1.40 (±0.92). Mean vomiting scores after chemotherapy in ginger arm were 0.719 (±1.03), 0.68 (±1.00) and 0.77 (± 1.18). In control arm, mean vomiting was 0.983 (± 1.23), 1.03 (± 1.22) and 1.15 (±1.27). In all sessions, ginger decreased vomiting severity from 1.4 (±1.04) to 0.71 (±0.86). None of the differences were significant. In those patients who received the AC regimen, vomiting was less severe (0.64 ± 0.87) comparing to those who received placebo (1.13±1.12), which was statistically significant (p-Value <0.05). Further and larger studies are needed to draw conclusions.arger studies are needed to draw conclusions.)
Publication: Clinical evaluation of safety and efficacy of Boswellia-based cream for prevention of adjuvant radiotherapy skin damage in mammary carcinoma: a randomized placebo controlled trial + (OBJECTIVE: Acute radiation erythema and ot … OBJECTIVE: Acute radiation erythema and other skin reactions are common adverse effects experienced by breast carcinoma patients undergoing radiotherapy treatment. Boswellic acids are pentacyclic triterpenes extracted from the resins of the tropical tree Boswellia serrata with strong anti-inflammatory properties. This study was designed to evaluate the safety and the efficacy of the application of a base cream contaning boswellic acids in a proprietary formulation (Bosexil(R)) for the prevention and relief of radiation-induced adverse effects in breast cancer patients.PATIENTS AND METHODS: The acute skin reactions were clinically evaluated by visual intensity and computer-assisted skin color analysis, and toxicity was assessed by the Radiation Therapy Oncology Group (RTOG) rating scale.RESULTS: These findings indicate that the use of a boswellia-based cream is effective in reducing the use of topical corticosteroids and is able to reduce the grade of erythema and the skin superficial symptoms, being well tolerated by the patients.CONCLUSIONS: Further studies comparing boswellia cream with other topical agents will be appropriate to confirm the effectiveness of this treatment for breast cancer patients under radiation therapy.t cancer patients under radiation therapy.)
Publication: Effect of Vitamin D Supplementation on Postcraniotomy Pain After Brain Tumor Surgery: A Randomized Clinical Trial + (OBJECTIVE: To determine the effect of vita … OBJECTIVE: To determine the effect of vitamin D supplementation on postoperative pain and analgesic requirement in brain tumor surgery.METHODS: A total of 60 patients with vitamin D serum levels £20 ng/dL were randomly assigned to 2 groups equally. The study group (n [ 30) received intramuscular injection of 300,000 IU vitamin D before surgery.RESULTS: Preoperative serum level of vitamin D was 15.9 ± 3.8 ng/dL and 14.5 ± 3.6 ng/dL in the study and control groups, respectively (P = 0.13). Serum level of vitamin D on day 5 of surgery was 22.5 ± 4.3 and 13.7 ± 3.8 in the study and control groups, respectively (P < 0.001). A percentage of 50% had pain scores >4 on the first postoperative day, which decreased with time. The median (interquartile range) of the visual analogue scale score during the 3 postoperative days was 3 (5), 3 (5), 1 (3), and 5 (7), 2 (5), 1 (3) in the study and control groups, respectively, with no significant difference. There was no difference in analgesic consumption between the 2 groups. Analysis through the generalized estimating equation model indicated that pa- tients who had received vitamin D for a longer time before the operative time had an insignificantly less pain score.CONCLUSIONS: On the basis of the study results, one half of our patients reported moderate-to-severe pain scores on the first day after surgery. The pain in the study group was insignificantly less than that in the control group, but it seems that chronic high level of vitamin D may lead to promising results.evel of vitamin D may lead to promising results.)
Publication: A randomized double-blind, placebo-controlled trial of zinc sulfate supplementation for alleviation of radiation-induced oral mucositis and pharyngitis in head and neck cancer patients + (OBJECTIVE: To determine the efficacy of zi … OBJECTIVE: To determine the efficacy of zinc sulfate supplementation in reducing of radiation-induced oral mucositis and pharyngitis in head and neck cancer patients. MATERIAL AND METHOD: One hundred forty four head and neck patients were enrolled in a randomized, double-blind, placebo-controlled trial. Patients who received radiation therapy alone or postoperative radiation therapy were eligible. Radiation therapy used conventional fractionation with 1.8 to 2.0 Gy perfraction, to total doses of 50 to 70 Gy over five to seven weeks. Drug and identically appearing placebo were self-administered 50 mg (10 cc) per meal, three times a day at mealtime. The zinc sulfate and placebo were administered beginning on the first day of radiation, and continued daily including weekends until radiation was completed Patients were evaluated before radiation, weekly during radiation and at the first month after completion of radiation. RESULTS: The baseline characteristics of patients, tumor, and treatment were not significantly different between the two groups. There were no statistically significant differences between the two treatment groups in frequency of patients experiencing greater than or equal to grade 2 oral mucositis andpharyngitis at each week during radiation and at the first month after completion of radiation. Six patients (17%) in the zinc sulfate and ten patients (23%) in placebo group developed grade 3 oral mucositis, which was not significantly different. Twenty-two patients (32%) in the zinc sulfate and nineteen patients (27%) in the placebo group developed grade 3 pharyngitis, which was not signifiibantly different. However there was no observation of grade 4 oral mucositis and pharyngitis in either group. Nausea and vomiting were mostly of mild degree. Adverse events were not statistically significant different between the two groups. CONCLUSION: It was concluded that zinc sulfate administered during head and neck radiation therapy produced no significant benefit in relieving radiation-induced oral mucositis and pharyngitis with acceptable side effects. pharyngitis with acceptable side effects.)
Publication: Randomized Trial of Vitamin C/E Complex for Prevention of Radiation- Induced Xerostomia in Patients with Head and Neck Cancer + (Objective. The present study was conducted … Objective. The present study was conducted to determine the preventive efficacy of vitamin C/E complex supplementation for radiotherapy (RT)–induced xerostomia in patients with head and neck cancer.Study Design. Prospective, double-blinded, randomized, placebo-controlled study.Setting. A single tertiary referral institution.Subjects and Methods. The trial group (n = 25) received antioxidant supplements (100 IU of vitamin E 1 500 mg of vitamin C) twice per day during RT, while the control group (n = 20) received an identical placebo. Pre-RT and 1 and 6 months post-RT, patient-reported xerostomia questionnaires, observer-rated xerostomia score, and salivary scintigraphy were serially obtained to compare xerostomia severity between the 2 groups.Results. The trial group showed greater improvements in xerostomia questionnaire and score at 6 months post-RT when compared with those at 1 month post-RT (P = .007 and .008, respectively). In contrast, the control group showed no changes between 1 and 6 months post-RT. By salivary scintigraphy, there was no difference in maximal accumulation or ejection fraction between the 2 groups. However, the trial group maintained significantly better oral indices at the prestimulatory (P = .01) and poststimulatory (P = .009) stages at 1 month post-RT, compared with the control group. At the final follow-up, there was no difference in overall survival and disease-free survival between the 2 groups.Conclusions. Our data suggest that short-term supplementation with an antioxidant vitamin E/C complex exerts a protectiveeffect against RT-induced xerostomia.tive effect against RT-induced xerostomia.)
Publication: Reflexology versus Swedish Massage to Reduce Physiologic Stress and Pain and Improve Mood in Nursing Home Residents with Cancer: A Pilot Trial. + (Objective. The purpose of this pilot study … Objective. The purpose of this pilot study was to investigate and compare the effects of reflexology and Swedish massage therapy on physiologic stress, pain, and mood in older cancer survivors residing in nursing homes. Methods. An experimental, repeated-measures, crossover design study of 18 nursing home residents aged 75 or over and diagnosed with solid tumor in the past 5 years and following completion of cancer treatments. The intervention tested was 20 minutes of Swedish Massage Therapy to the lower extremities, versus 20 minute Reflexology, using highly specified protocols. Pre- and post-intervention levels of salivary cortisol, observed affect, and pain were compared in the Swedish Massage Therapy and Reflexology conditions. Results. Both Reflexology and Swedish Massage resulted in significant declines in salivary cortisol and pain and improvements in mood. Conclusions. Preliminary data suggest that studies of Swedish Massage Therapy and Reflexology are feasible in this population of cancer survivors typically excluded from trials. Both interventions were well tolerated and produced measurable improvements in outcomes. Further research is needed to explore the mechanisms underlying the potential benefits of these CAM modalities in this patient population.CAM modalities in this patient population.)
Publication: The Effect of Reflexology on Chemotherapy-induced Nausea, Vomiting, and Fatigue on Breast Cancer Patients. + (Objective: Patients receiving chemotherapy … Objective:Patients receiving chemotherapy struggle with the side effects of this treatment. These side effects obligate the patients to use not only the pharmacological methods but also non-pharmacological relaxing methods. This study was conducted to determine the effect of reflexology on chemotherapy-induced nausea, vomiting, and fatigue in breast cancer patients.Methods:The study was conducted as a pretest–posttest experimental design. The study was conducted with sixty patients, thirty as the control and thirty as the experimental groups. A sociodemographic form, Rhodes index of nausea, vomiting, and retching (INVR), and Brief Fatigue Inventory (BFI) were used to collect the data. Analysis of variance, t-test, percentage calculations, and Chi-square methods were used to evaluate the data. The data obtained were assessed using the “Statistical Package for Social Science 21.0” software.Results:It was determined that the difference between the total mean scores of INVR in the experimental and control groups was significant on the onset and first and second measurements, and the difference between total mean scores of development and distress between the groups was statistically significant in the third measurement (P < 0.05). The results of the study showed that the BFI mean scores of patients in the experimental group gradually decreased in the first, second, and third measurements (P < 0.05).Conclusions:The present study proved that reflexology decreased the experience, development, distress of nausea, vomiting, and retching as well as fatigue in the experimental group. Hence, the use of reflexology is recommended for chemotherapy-induced nausea, vomiting, and fatigue.motherapy-induced nausea, vomiting, and fatigue.)
Publication: Selenium Substitution During Radiotherapy of Solid Tumours Laboratory Data from Two Observation Studies in Gynaecological and Head and Neck Cancer Patients + (Objective: Selenium is an essential cofact … Objective: Selenium is an essential cofactor of the enzyme glutathione peroxidase (GSH-Px), which is important for the endogenous detoxification of free radicals. A reduced activity of GSH-Px is related to increased toxicities due to radiation therapy during primary cancer treatment. Therefore, selenium substitution may be a new supportive strategy to diminish radiation-associated side effects. Patients and Methods: The selenium blood concentrations of 121 radiotherapy patients were measured in two randomized observation studies (81 gynaecological tumours, 40 head and neck tumours). Measurements (atom absorption spectrometry) were performed on serum and whole blood (WB) samples before, in the middle of, at the end, and 6 weeks after radiotherapy. In cases of decreased selenium levels in WB, 63 patients (mean age 63.83±9.23 a) received selenium substitution (500 μg sodium selenite at RT days, 300 μg at the weekend) and 64 patients (mean age 63.03±10.47 years) were evaluated as control group without any selenium substitution. Both groups were well balanced according to tumour localization and stage. Reference values were 85-162 μg/l WB-selenium, and 65-135 μg/l serum-selenium. Results: We measured the following WB selenium (Se) levels (Se-group vs. control group, U-test): begin RT 64.17±13.98 μg/l vs. 64.50±14.47 μg/l (p=0.869); mid RT 92.48±26.68 μg/l vs. 65.80±18.04 μg/l (p<0.001); end RT 93.78±25.90 μg/l vs. 64.06±17.54 μg/l (p<0.001); 6 weeks after RT 74.01±20.06 μg/l vs. 69.66±17.83 μg/l (p=0.183). The serum levels were as follows: begin RT 59.18±13.49 μg/l vs. 61.99±15.72 μg/l (p=0.427); mid RT 104.75±31.41 μg/l vs. 62.37±16.23 μg/l (p<0.001); end RT 100.63±31.12 μg/l vs. 62.29±16.11 μg/l (p<0.001); 6 weeks after RT 72.73±26.53 μg/l vs. 64.17±17.22 μg/l (p=0.170). Conclusion: The used dosage of 500 μg sodium selenite per day is sufficient to treat selenium deficiency during radiotherapy. After substitution, the patient returns to their individual selenium status.e patient returns to their individual selenium status.)
Publication: The chemopreventive effect of Ginkgo biloba extract 761 against cisplatin ototoxicity: a pilot study + (Objective: The purpose of this study was t … Objective: The purpose of this study was to evaluate, by using distortion product otoacoustic emission test, the action of Ginkgo biloba extract 761, which has a known antioxidant property, as a possible otoprotective against cisplatin-induced hearing loss. This prospective and double-blinded study was conducted on individuals that were to begin cisplatin treatment in a tertiary university center. They were randomized and allocated into two groups: control group (CG) (n=07) receiving placebo and cisplatin and study group (SG) (n=08) receiving Ginkgo biloba extract 761 (240 mg/day) and cisplatin. Methods: This prospective study was conducted on individuals that were treated for cancer with cisplatin (CDDP) in a tertiary university center. Both groups were instructed to ingest either placebo or Ginkgo biloba extract 761 before the first cisplatin dose. They were rated and followed up for approximately 90 days. The maximum cumulative cisplatin dosage was 300 mg/m². The ototoxic effect was measured with distortion product otoacoustic emissions. Distortion product otoacoustic emissions were recorded before the first cisplatin cycle, and 30, 60, and 90 days after the treatment. The average of the amplitude of the signals was calculated and used for comparisons between the groups. Results: Comparisons were made between baseline measurements and those recorded after the maximum cumulative CDDP dose. The control group showed smaller distortion product otoacoustic emissions mean amplitudes and smaller signal/noise ratio than the study group (p<0.05). Conclusion: Ginkgo biloba extract 761 probably has antioxidant properties and might play an otoprotective role against cisplatin ototoxicity in these patients.inst cisplatin ototoxicity in these patients.)
Publication: Limited effects of selenium in the prevention of radiation-associated toxicities - results of a randomized study in head neck cancer patients + (Objective: The substitution of selenium ac … Objective: The substitution of selenium activates the selenium-dependent enzyme glutathione peroxidase, which is important for scavenging free radicals. To date, only limited data are available about the clinical impact of selenium regarding the toxicities due to free radical producing therapies, e.g. irradiation or chemotherapy, and therefore the objective of this study was to investigate the clinical impact of selenium in such therapies. Patients and Methods: 39 patients (8 female, 31 male) with advanced head and neck cancer were included in a randomised phase II study. The mean age was 63.52±9.31 years. Tumour localizations: oral cavity 15 patients, oropharynx 19 patients, hypopharynx 5 patients, carcinoma of unknown primary 1 patient. Group A (n=22) received 500 μg sodium selenite on the days of radiotherapy and 300 μg sodium selenite on days without radiotherapy. Group B (17) was irradiated without any selenium substitution. Both groups were well balanced according to age, gender, localization and stage of the tumour. The RTOG grade of radiation-associated toxicities was evaluated once per week. Results: The following serious toxicities were observed (group A vs. group B): dysphagia 22.7% vs. 35.3%, loss of taste 22.7% vs. 47.1%, dry mouth 22.7% vs. 23.5%, and stomatitis 36.4% vs. 23.5%. A statistical trend (Fisher’s exact test) was only seen for the loss of taste (p=0.172). The weekly patient analysis (Student’s t-test) showed a significant reduction of dysphagia in the selenium group (Group 1) at the last week of irradiation. Conclusion: This small randomised trial showed limited effects of selenium in the prevention of ageusia (loss of taste) and dysphagia due to radiotherapy of head and neck cancer.e to radiotherapy of head and neck cancer.)
Publication: Effects of inhaled ginger aromatherapy on chemotherapy-induced nausea and vomiting and health-related quality of life in women with breast cancer + (Objective: To assess the efficacy of inhal … Objective: To assess the efficacy of inhaled ginger aromatherapy on nausea, vomiting and health-related quality of life (HRQoL) in chemotherapy breast cancer patients.Design: Single-blind, controlled, randomized cross-over study. Patients received 5-day aromatherapy treatment using either ginger essential oil or fragrance-matched artificial placebo (ginger fragrance oil) which was instilled in a necklace in an order dictated by the treatment group sequence.Setting: Two oncology clinics in the East Coast of Peninsular Malaysia.Main outcome measures: VAS nausea score, frequency of vomiting and HRQoL profile (EORTC QLQ-C30 scores).Results: Sixty female patients completed the study (age = 47.3 ± 9.26 years; Malay = 98.3%; on highly emetogenic chemotherapy = 86.7%). The VAS nausea score was significantly lower after ginger essential oil inhalation compared to placebo during acute phase (P = 0.040) but not sus- tained for overall treatment effect (treatment effect: F = 1.82, P = 0.183; time effect: F = 43.98, P < 0.001; treatment × time effect: F = 2.04; P = 0.102). Similarly, there was no significant effect of aromatherapy on vomiting [F(1, 58)=0.29, P=0.594]. However, a statistically significant change from baseline for global health status (P < 0.001) was detected after ginger essential oil inhalation. A clinically relevant 10 points improvement on role functioning (P = 0.002) and appetite loss (P < 0.001) were also documented while patients were on ginger essential oil.mented while patients were on ginger essential oil.)
Publication: Effects of zinc supplementation on fatigue and quality of life in patients with colorectal cancer + (Objective: To investigate the effects of o … Objective: To investigate the effects of oral zinc supplementation on fatigue intensity and quality of life of patients during chemotherapy for colorectal cancer. Methods: A prospective, randomized, double-blinded, placebo-controlled study was conducted with 24 patients on chemotherapy for colorectal adenocarcinoma in a tertiary care public hospital. The study patients received zinc capsules 35mg (Zinc Group, n=10) or placebo (Placebo Group, n=14) orally, twice daily (70mg/day), for 16 weeks, from the immediate postoperative period to the fourth chemotherapy cycle. Approximately 45 days after surgical resection of the tumor, all patients received a chemotherapeutic regimen. Before each of the four cycles of chemotherapy, the Functional Assessment of Chronic Illness Therapy-Fatigue scale was completed. We used a linear mixed model for longitudinal data for statistical analysis. Results: The scores of quality of life and fatigue questionnaires were similar between the groups during the chemotherapy cycles. The Placebo Group presented worsening of quality of life and increased fatigue between the first and fourth cycles of chemotherapy, but there were no changes in the scores of quality of life or fatigue in the Zinc Group. Conclusion: Zinc supplementation prevented fatigue and maintained quality of life of patients with colorectal cancer on chemotherapy.ts with colorectal cancer on chemotherapy.)
Publication: Ginger as an antiemetic in nausea and vomiting induced by chemotherapy: A randomized, cross-over, double blind study + (Objective: To study the antiemetic effect … Objective: To study the antiemetic effect of ginger root on nausea and vomiting induced by cyclophosphamide.Methods: A randomized, prospective, cross-over, double-blind study was carried out in patients receiving cyclophosphamide in combination with other chemotherapeutic agents. Patients with atleast two episodes of vomiting in the previous cycle were included. The patients were randomly assigned to receive one of the three antiemetics: ginger, metoclopramide or ondansetron in the first cycle. They were admitted in the ward for 24 h and observed for the incidence of nausea and vomiting and adverse effects if any, were recorded. Patients were crossed over to receive the other antiemetic treatments during the two successive cycles of chemotherapy.Results: Complete control of nausea was achieved in 62% of patients on ginger, 58% with metoclopramide and 86% with ondansetron. Complete control of vomiting was achieved in 68% of patients on ginger, 64% with metoclopramide and 86% with ondansetron. No adverse effects attributable to ginger were recorded.Conclusion: Powdered ginger root in the dose used was found to be effective in reducing nausea and vomiting induced by low dose cyclophosphamide in combination with drugs causing mild emesis. The antiemetic efficacy of ginger was found to be equal to that of metoclopramide but ondansetron was found to be superior than the other two.s found to be superior than the other two.)
Publication: Acetyl-L-carnitine plus propionyl-L-carnitine improve efficacy of sildenafil in treatment of erectile dysfunction after bilateral nerve-sparing radical retropubic prostatectomy + (Objectives To determine whether propionyl- … ObjectivesTo determine whether propionyl-l-carnitine (PLC) plus acetyl-l-carnitine (ALC) improves the effectiveness of sildenafil in restoring sexual potency after bilateral nerve-sparing radical retropubic prostatectomy.MethodsWe analyzed the data from 96 patients who had undergone bilateral nerve-sparing radical retropubic prostatectomy: 33 were given placebo (group 1), 32 used PLC 2 g/day plus ALC 2 g/day plus sildenafil 100 mg when needed (group 2), and 35 used sildenafil alone (group 3). The studied variables were sexual function (assessed through sexual behavior interviews and the International Index of Erectile Function), peak systolic velocity and end-diastolic velocity of cavernosal arteries (assayed by dynamic echo-color Doppler), the percentage of patients able to achieve a positive intracavernous injection test, and side effects.ResultsPlacebo proved ineffective and sildenafil and sildenafil plus ALC and PLC proved effective. The International Index of Erectile Function-15 scores of the group 2 patients were significantly greater than those of group 3 in the following domains: erectile function, sexual intercourse satisfaction, orgasm, and general sexual well-being. The drugs did not significantly modify the score in the sexual desire domain or in the peak systolic velocity or end-diastolic velocity of the cavernosal arteries. Sexual behavior interviews revealed that 2 of 29 in group 1, 28 of 32 in group 2, and 20 of 39 in group 3 attained satisfactory sexual intercourse (P <0.01). Only group 2 had a significantly increased percentage of patients with a positive intracavernous injection test after therapy (36.4% versus 63.6%; P <0.01). ALC plus PLC did not significantly improve the side effects of sildenafil.ConclusionsPLC and ALC proved to be safe and reliable in improving the efficacy of sildenafil in restoring sexual potency after bilateral nerve-sparing radical retropubic prostatectomy. nerve-sparing radical retropubic prostatectomy.)
Publication: Radioprotective effect of vitamin E on salivary glands after radioiodine therapy for differential thyroid cancer: A randomized-controlled trial + (Objectives This study aimed to examine th … Objectives This study aimed to examine the radioprotective effect of vitamin E on salivary glands after radioactive iodine (131I) therapy in patients with differentiated thyroid cancer. Patients and methods Eighty-two patients with differentiated thyroid cancer were enrolled in this study. They were divided randomly into four groups (control group: 22 cases, group A: 23 cases, group B: 22 cases, and group C: 15 cases) before postsurgical ablation therapy with 100 mCi 131I. The patients in groups A, B, and C received vitamin E 100, 200, and 300 mg/day orally, respectively, for a duration of 1 week before to 4 weeks after 131I therapy. Salivary gland function was assessed using salivary gland scintigraphy immediately before and 6 months after 131I therapy. Uptake fraction (UF), uptake index (UI), excretion fraction (EF), and excretion ratio (ER) of each salivary gland were measured and compared. Results On comparison between before and after 131I therapy in the control group, there was a significant decrease in UF of both right and left parotid glands (all P<0.01). In group A, a significant increase in EF of the right parotid gland (P<0.01) and UI of the right submandibular gland (P<0.05) was found. In group B, there was a significant increase in UI of the right parotid gland and both submandibular glands (all P<0.01). In group C, there was a significant increase in UF of the left parotid gland (P<0.05) and the right submandibular gland (P<0.01). Also, there was a statistical increase in UI in both submandibular glands (all P<0.01). However, on comparing the changes in the post-131I therapy salivary scintigraphy parameters among the four groups, there was a significant difference in ΔUI of the right parotid gland (P<0.05) and both submandibular glands (all P<0.01), as well as ΔER of the left parotid gland (P<0.05) and ΔUF of the left submandibular gland (P<0.05). Conclusion Vitamin E exerts significant protective effects on the parotid and submandibular glands after 131I therapy.d (P<0.05). Conclusion Vitamin E exerts significant protective effects on the parotid and submandibular glands after 131I therapy.)
Publication: Does vitamin E protect salivary glands from I-131 radiation damage in patients with thyroid cancer? + (Objectives Salivary gland impairment after … Objectives Salivary gland impairment after high-dose radioiodine (131I) treatment is well recognized. The aim of this study was to determine the protective effect of vitamin E on radiation-induced salivary gland dysfunction in patients undergoing 131I treatment for differentiated thyroid cancer. Methods Thirty-six patients with differentiated thyroid carcinoma were enrolled in this study. They were randomly divided into two groups before postsurgical ablation therapy with 3700–5550MBq 131I: the control group, comprising 17 patients, and the vitamin E group, comprising 19 patients. All 19 patients in the experimental group received vitamin E at a dose of 800 IU/day for a duration of 1 week before to 4 weeks after 131I therapy and the 17 patients in the control group received a placebo for the same duration. Salivary gland function was assessed using salivary gland scintigraphy with intravenous injection of 370MBq 99mTc-pertechnetate in two phases, one immediately before and the other 6 months after 131I ablative therapy. First-minute uptake ratio, maximum uptake ratio, maximum secretion percentage, and excretion fraction (EF) of each salivary gland were measured and compared between the study phases for the two groups. Results There was no significant difference between preablative and postablative salivary scintigraphic indices in the experimental vitamin E group, whereas maximum secretion percentage and EF of the right submandibular gland and EF of the left parotid gland were significantly decreased in the control group. There was also a higher significant decrease in the EF of the left parotid gland in the control group compared with the vitamin E group. Conclusion Vitamin E consumption may be associated with a significant protective effect against radiation-induced dysfunction in salivary glands following single-dose 131I therapy in patients with differentiated thyroid cancer.n in salivary glands following single-dose 131I therapy in patients with differentiated thyroid cancer.)
Publication: Improving Quality of Life With Nabilone During Radiotherapy Treatments for Head and Neck Cancers: A Randomized Double-Blind Placebo-Controlled Trial + (Objectives: Patients treated for head and … Objectives: Patients treated for head and neck carcinomas experience a significant deterioration of their quality of life during treatments because of severe side effects. Nabilone has many properties that could alleviate symptoms caused by radiotherapy and improve patients’ quality of life. The aim of the present study was to compare the effects of nabilone versus placebo on the quality of life and side effects during radiotherapy for head and neck carcinomas.Methods: Fifty-six patients were randomized to nabilone or placebo. Patients filled the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and the EORTC QLQ-H&N35; three independent questionnaires assessing appetite, nausea, and toxicity; and a visual analog scale for pain. These data were collected before radiotherapy, each week during radiotherapy, and 4 weeks after radiotherapy. Patients were weighed every week.Results: Nabilone did not lengthen the time necessary for a 15% deterioration of quality of life (P = .4279), and it was not better than placebo for relieving symptoms like pain (P = .6048), nausea (P = .7105), loss of appetite (P = .3295), weight (P = .1454), mood (P = .3214), and sleep (P = .4438).Conclusion: At the dosage used, nabilone was not potent enough to improve the patients’ quality of life over placebo.ve the patients’ quality of life over placebo.)
Publication: Comparison of the Complications of Platinum-Based Adjuvant Chemotherapy With and Without Ginger in a Pilot Study on Ovarian Cancer Patients + (Objectives: The principal treatment of ova … Objectives: The principal treatment of ovarian cancer is surgery with or without chemotherapy. The chemotherapy, however, might be ineffective and long with serious side-effects. To obviate these shortcomings, more efficient and safer medications are required, among which ginger has recently gained popularity because of its anti-cancer properties. This study aims to compare outcomes and side-effects of adjuvant chemotherapy with and without ginger in ovarian cancer patients. Materials and Methods: A total of 49 patients (20 patients in case group and 29 patients in control group) with stage I to III, histopathologically proved ovarian cancer underwent cytoreductive surgery followed by platinum-based adjuvant chemotherapy with and without investigator-prepared oral ginger capsules (2 g per day for 6 cycles). Potential side-effects, poor 12-month outcome (serum CA125 levels >35U, radiologic evidence of metastasis and recurrence, or death), and 12-month disease-free survival were documented and compared between the 2 groups. Results: Poor outcome including serum CA125>35, metastasis, recurrence or death was documented more common in control group (69% versus 40%). metastasis frequency confirmed by computerized tomography (CT) scan 6 month after treatment was significantly lower in case group (P = 0.04). There was no significant difference regarding mortality and disease free survival during one year follow-up after treatment between 2 groups (P = 0.55). Chemotherapy complications such as nausea, vomiting, weight loss, and peripheral neuropathy were detected in case group less than control group but the difference was not significant. Conclusion: Oral administration of ginger is along with a significantly better 12-month outcome in patients on chemotherapy because of ovarian cancer, and accordingly, considering its safety, its administration is recommended.g its safety, its administration is recommended.)
Publication: The efficacy of selenium in prevention of oral mucositis in patients undergoing hematopoietic SCT: a randomized clinical trial + (Oral mucositis (OM) is a complication of h … Oral mucositis (OM) is a complication of high-dose chemotherapy (HDC) followed by hematopoietic SCT (HSCT) with few effective treatments. Selenium has a cytoprotective role via the glutathione peroxidase (Glu.Px) enzyme and prevents chemotherapy-induced toxicities. We performed a double-blind, randomized, placebo-controlled study to evaluate the efficacy of selenium on the prevention of OM in 77 patients with leukemia, undergoing allogeneic HSCT. Thirty-seven patients received oral selenium tablets (200 mcg twice daily) from the starting day of HDC to 14 days after transplantation. OM was evaluated daily for 21 days after transplantation according to World Health Organization oral toxicity scale. The incidence of severe OM (grades 3–4) was significantly lower in the selenium group (10.8% vs. 35.1%, p<0.05). We noted that the duration of objective OM (grades 2–4), excluding patient’s self-declaration (grade 1), was significantly shorter in the selenium group (3.6±1.84 vs. 5.3±2.2 days, p=0.014). Significant elevations in serum selenium level and plasma Glu.Px activity were observed 7 and 14 days after transplantation compared with baseline in the selenium group. We conclude that selenium can reduce the duration and severity of OM after HDC.ce the duration and severity of OM after HDC.)
Publication: Polaprezinc prevents oral mucositis associated with radiochemotherapy in patients with head and neck cancer + (Oral mucositis is frequent but serious adv … Oral mucositis is frequent but serious adverse event associated with radiotherapy or radiochemotherapy in head and neck cancer severely impairs health-related quality of life, leading to poor prognosis due to discontinuation of the therapy. Although a number of compounds have been tested for prophylaxis of oral mucositis, few of them are satisfactory. We investigated the effect of polaprezinc (zinc L-carnosine), a gastric mucosal protective drug, on radiochemotherapy-induced oral mucositis, pain, xerostomia and taste disturbance in patients with head and neck cancer. Patients were randomly assigned to receive polaprezinc (n = 16) or azulene oral rinse as the control (n = 15). The incidence rates of mucositis, pain, xerostomia and taste disturbance were all markedly lower in polaprezinc group than in control. Moreover, the use of analgesics was significantly (p = 0.003) less frequent and the amount of food intake was significantly (p = 0.002) higher in polaprezinc group than in control. On the other hand, tumor response rate in patients with neoadjuvant radiochemotherapy was not significantly affected by polaprezinc, in which the response rate (complete plus partial response) was 88% for polaprezinc and 92% for control (p = 1.000). Therefore, it is highly assumable that polaprezinc is potentially useful for prevention of oral mucositis and improvement of quality of life without reducing the tumor response. life without reducing the tumor response.)
Publication: Does zinc sulfate prevent therapy-induced taste alterations in head and neck cancer patients? Results of phase III double-blind, placebo-controlled trial from the North Central Cancer Treatment Group (N01C4) + (PURPOSE: Taste alterations (dysgeusia) are … PURPOSE: Taste alterations (dysgeusia) are well described in head and neck cancer patients who undergo radiotherapy (RT). Anecdotal observations and pilot studies have suggested zinc may mitigate these symptoms. This multi-institutional, double-blind, placebo-controlled trial was conducted to provide definitive evidence of this mineral's palliative efficacy. METHODS AND MATERIALS: A total of 169 evaluable patients were randomly assigned to zinc sulfate 45 mg orally three times daily vs. placebo. Treatment was to be given throughout RT and for 1 month after. All patients were scheduled to receive > or =2,000 cGy of external beam RT to > or =30% of the oral cavity, were able to take oral medication, and had no oral thrush at study entry. Changes in taste were assessed using the previously validated Wickham questionnaire. RESULTS: At baseline, the groups were comparable in age, gender, and planned radiation dose (<6,000 vs. > or =6,000 cGy). Overall, 61 zinc-treated (73%) and 71 placebo-exposed (84%) patients described taste alterations during the first 2 months (p = 0.16). The median interval to taste alterations was 2.3 vs. 1.6 weeks in the zinc-treated and placebo-exposed patients, respectively (p = 0.09). The reported taste alterations included the absence of any taste (16%), bitter taste (8%), salty taste (5%), sour taste (4%), sweet taste (5%), and the presence of a metallic taste (10%), as well as other descriptions provided by a write in response (81%). Zinc sulfate did not favorably affect the interval to taste recovery. CONCLUSION: Zinc sulfate, as prescribed in this trial, did not prevent taste alterations in cancer patients who were undergoing RT to the oral pharynx.r patients who were undergoing RT to the oral pharynx.)
Publication: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Retinol Palmitate (Vitamin A) for Symptomatic Chronic Radiation Proctopathy + (PURPOSE: This study was designed to determ … PURPOSE: This study was designed to determine whether oral retinol palmitate (vitamin A) can reduce the symptomsof radiation proctopathy. METHODS: A randomized, doubleblind trial comparing retinol palmitate (10,000 IU by mouth for 90 days) to placebo was conducted. Eligible patients were more than six months postpelvic radiotherapy and had significant symptoms as measured with the Radiation Proctopathy System Assessments Scale. Nineteen patients were randomized in total: ten to retinol palmitate and nine to placebo. The Radiation Proctopathy System Assessments Scale scores before and every 30 days for 90 days were measured. Five placebo nonresponders were crossed over to the retinol palmitate for another 90 days. Response was defined as a reduction in two or more symptoms by at least two Radiation Proctopathy System Assessments Scale points. RESULTS: Seven of ten retinol palmitate patients responded, whereas two of nine responded to placebo (P=0.057). Mean pre-post-treatment change in Radiation Proctopathy System Assessments Scale (Radiation Proctopathy System Assessments Scale) in the retinol palmitate group was 11 ± 5, whereas Radiation Proctopathy System Assessments Scale in the placebo group was 2.5 ± 3.6 (P=0.013, Mann-Whitney U test). Additionally, all five placebo nonresponders who were crossed over to treatment with retinal palmitate responded to treatment. CONCLUSIONS: In our trial, retinol palmitate significantly reduced rectal symptoms of radiation proctopathy, perhaps because of wound-healing effects. The current results can serve as the foundation for future trials examining retinol palmitate in the multi-institutional setting.mitate in the multi-institutional setting.)
Publication: Zinc sulfate in the prevention of radiation-induced oropharyngeal mucositis: a prospective, placebo-controlled, randomized study + (PURPOSE: To determine the effect of oral z … PURPOSE: To determine the effect of oral zinc sulphate supplementation on radiation-induced oropharyngeal mucositis in patients with head-and-neck cancer. MATERIALS AND METHODS: Thirty patients with head-and-neck cancer were randomly assigned to receive either zinc sulfate or placebo. Primary tumors were localized in the larynx in 14 patients, in the nasopharynx in 4, in the oral cavity in 4, in a salivary gland in 1, in the maxillary sinus in 1, in neck nodes (lymphoma presenting primarily) in 3 and in neck metastases from an unknown primary in 3. In the placebo group, 3 patients were excluded; 1 patient died during treatment, 1 left the study, and 1 did not come to the 6 week control visit. The patients were treated with telecobalt radiotherapy at conventional fractionation (2 Gy/fraction, five fractions weekly, for 20-35 fractions within 4-7 weeks). The median radiation dose was 6400 cGy (4000-7000 cGy). Oral mucositis was assessed by two independent physicians, experts in radiation oncology, using the Radiation Therapy Oncology Group Acute Radiation Morbidity Scoring criteria. RESULTS: In the zinc sulfate group, Grade 3-4 mucositis was not detected in any patient; Grade 0 mucositis was detected in 2, and Grade 1 in 8, and Grade 2 in 5 patients. In the placebo group, Grade 2 mucositis was detected in 4 and Grade 3 in 8 patients. We observed that the degree of mucositis in the patients in the zinc sulfate group was significantly lower than that in the placebo group (p < 0.05). Confluent mucositis developed earlier in the placebo group than in the zinc sulfate group after the onset of treatment (p < 0.05) and started to improve sooner in the zinc sulfate group than in the placebo group (p < 0.05). CONCLUSIONS: Zinc sulfate is beneficial in decreasing the severity of radiation-induced mucositis and oral discomfort. These results should be confirmed by additional evaluation in randomized studies with a larger number of patients.andomized studies with a larger number of patients.)
Publication: Nabiximols for Opioid-Treated Cancer Patients With Poorly-Controlled Chronic Pain: A Randomized, Placebo-Controlled, Graded-Dose Trial + (Patients with advanced cancer who have pai … Patients with advanced cancer who have pain that responds poorly to opioid therapy pose a clinical challenge. Nabiximols (Nabiximols is the US Adopted Name (USAN) for Sativex (GW Pharma Ltd, Wiltshire, UK), which does not yet have an INN), a novel cannabinoid formulation, is undergoing investigation as add-on therapy for this population. In a randomized, double-blind, placebo-controlled, graded-dose study, patients with advanced cancer and opioid-refractory pain received placebo or nabiximols at a low dose (1–4 sprays/day), medium dose (6–10 sprays/day), or high dose (11–16 sprays/day). Average pain, worst pain and sleep disruption were measured daily during 5 weeks of treatment; other questionnaires measured quality of life and mood. A total of 360 patients were randomized; 263 completed. There were no baseline differences across groups. The 30% responder rate primary analysis was not significant for nabiximols versus placebo (overall P = .59). A secondary continuous responder analysis of average daily pain from baseline to end of study demonstrated that the proportion of patients reporting analgesia was greater for nabiximols than placebo overall (P = .035), and specifically in the low-dose (P = .008) and medium-dose (P = .039) groups. In the low-dose group, results were similar for mean average pain (P = .006), mean worst pain (P = .011), and mean sleep disruption (P = .003). Other questionnaires showed no significant group differences. Adverse events were dose-related and only the high-dose group compared unfavorably with placebo. This study supports the efficacy and safety of nabiximols at the 2 lower-dose levels and provides important dose information for future trials.Perspective: Nabiximols, a novel cannabinoid formulation, may be a useful add-on analgesic for patients with opioid-refractory cancer pain. A randomized, double-blind, placebo controlled, graded-dose study demonstrated efficacy and safety at low and medium doses.ficacy and safety at low and medium doses.)