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Publication: Randomized, Double-Blinded Phase II Evaluation of Docetaxel with or without Doxercalciferol in Patients with Metastatic, Androgen-Independent Prostate Cancer +
Purpose: Docetaxel is standard of care for androgen-independent prostate cancer (AIPC). Doxercalciferol (1α-hydroxyvitamin D2) had modest activity in phase I/II trials. Preclinical data support combining vitamin D analogues with docetaxel to treat AIPC.
Experimental Design: Chemotherapy-naive men with metastatic AIPC were randomized 1:1to receive, on a 4-week cycle, docetaxel (35 mg/m2 i.v., days1, 8, and15) with or without doxercalciferol (10 μg orally, days 1–28). The primary end point was prostate-specific antigen (PSA) response. Secondary end points were progression-free survival, overall survival, objective response, and toxicity. Survival was analyzed as intent to treat.
Results: Seventy patients were randomized. Median follow-up was 17.6 months (range, 3.3-45.2). PSA response rate was 46.7% (95% confidence interval (95% CI), 30-64) in the doxercalciferol arm and 39.4% (95% CI, 25-56) with placebo (p = 0.560). Median progression-free survival in the doxercalciferol arm was 6.17 months (95% CI, 4.20-10.7) versus 6.20 months (95% CI, 4.83-9.07) with placebo (p = 0.764). Median overall survival in the doxercalciferol arm was 17.8 months (95% CI, 14.9-23.6) versus 16.4 months (95% CI, 11.9-23.8) with placebo (p = 0.383). Twenty-four patients in the doxercalciferol arm and 23 in the placebo arm were evaluable for objective response. No complete responses were observed. Partial objective response rate was 12.5% with doxercalciferol versus 8.7% with placebo (p = 0.672). Rate of grade ≥3 toxicity was 46% with doxercalciferol versus 42% with placebo (p = 0.785).
Conclusions: Daily doxercalciferol with weekly docetaxel did not enhance PSA response rate or survival. Toxicity was similar between arms. Despite the disappointing results of this study, other vitamin D analogues remain under active investigation. +
Publication: Randomized, blinded trial of vitamin D3 for treating aromatase inhibitor-associated musculoskeletal symptoms (AIMSS) +
Purpose: To evaluate the efficacy and safety of vitamin D3 at 4,000 IU/day as a treatment option for aromatase inhibitor associated musculoskeletal symptoms (AIMSS) when compared with the usual care dose of 600 IU D3.
Methods: Single site randomized, double-blind, phase 3 clinical trial in women with AIMSS comparing change in symptoms, reproductive hormones and AI pharmacokinetics. Postmenopausal women ≥18 years with stage I-IIIA breast cancer, taking AI and experiencing AIMSS (Breast Cancer Prevention Trial Symptom Scale-Musculoskeletal Subscale ≥1.5 (BCPT-MS)) were admitted. Following randomization, 116 patients had a run-in period of 1 month on 600 IU D3, then began the randomized assignment to either 600 IU D3 (n=56) or 4,000 IU D3 (n=57) aily for 6 months. The primary endpoint was change in AIMSS from baseline (after 1 month run-in) on the BCPT-MS (general musculoskeletal pain; joint pain; muscle stiffness; range for each question: 0=not at all to 4=extremely).
Results: Groups had no statistically significant differences demographically or clinically. There were no discernable differences between the randomly allocated treatment groups at 6 months in measures of AIMSS, pharmacokinetics of anastrozole and letrozole, serum levels of reproductive hormones, or adverse events.
Conclusions: We found no significant changes in AIMSS measures between women who took 4000 IU D3 daily compared with 600 IU D3. The 4000 IU D3 did not adversely affect reproductive hormone levels or the steady state pharmacokinetics of anastrozole or letrozole. In both groups, serum 25(OH)D remained in the recommended range for bone health (≥30 ng/mL) and safety (<50 ng/mL). +
Publication: Randomized, double-blind, placebo-controlled, phase III chemoprevention trial of selenium supplementation in patients with resected stage I non-small-cell lung cancer: ECOG 5597 +
Purpose: Selenium has been reported to have chemopreventive benefits in lung cancer. We conducted a double-blind, placebo-controlled trial to evaluate the incidence of second primary tumors (SPTs) in patients with resected non–small-cell lung cancer (NSCLC) receiving selenium supplementation.
Patients and Methods
Patients: with completely resected stage I NSCLC were randomly assigned to take selenized yeast 200 µg versus placebo daily for 48 months. Participation was 6 to 36 months postoperatively and required a negative mediastinal node biopsy, no excessive vitamin intake, normal liver function, negative chest x-ray, and no other evidence of recurrence.
Results: The first interim analysis in October 2009, with 46% of the projected end points accumulated, showed a trend in favor of the placebo group with a low likelihood that the trial would become positive; thus, the study was stopped. One thousand seven hundred seventy-two participants were enrolled, with 1,561 patients randomly assigned. Analysis was updated in June 2011 with the maturation of 54% of the planned end points. Two hundred fifty-two SPTs (from 224 patients) developed, of which 98 (from 97 patients) were lung cancer (38.9%). Lung and overall SPT incidence were 1.62 and 3.54 per 100 person-years, respectively, for selenium versus 1.30 and 3.39 per 100 person-years, respectively, for placebo (P = .294). Five-year disease-free survival was 74.4% for selenium recipients versus 79.6% for placebo recipients. Grade 1 to 2 toxicity occurred in 31% of selenium recipients and 26% of placebo recipients, and grade 3 toxicity occurred in less than 2% of selenium recipients versus 3% of placebo recipients. Compliance was excellent. No increase in diabetes mellitus or skin cancer was detected.
Conclusion: Selenium was safe but conferred no benefit over placebo in the prevention of SPT in patients with resected NSCLC. +
Publication: Randomized, open-label phase III trial of docetaxel plus high-dose calcitriol versus docetaxel plus prednisone for patients with castration-resistant prostate cancer +
Purpose: To compare the efficacy and safety of docetaxel plus high-dose calcitriol (DN-101) to docetaxel plus prednisone in an open-label phase III trial.
Patients and Methods: Nine hundred fifty-three men with metastatic castration-resistant prostate cancer (CRPC) were randomly assigned to Androgen-Independent Prostate Cancer Study of Calcitriol Enhancing Taxotere (ASCENT; 45 μg DN-101, 36 mg/m<sup>2</sup> docetaxel, and 24 mg dexamethasone weekly for 3 of every 4 weeks) or control (5 mg prednisone twice daily with 75 mg/m<sup>2</sup> docetaxel and 24 mg dexamethasone every 3 weeks) arms. The primary end point was overall survival (OS), assessed by the Kaplan-Meier method.
Results: At an interim analysis, more deaths were noted in the ASCENT arm, and the trial was halted. The median-follow-up for patients alive at last assessment was 11.7 months. Median OS was 17.8 months (95% CI, 16.0 to 19.5) in the ASCENT arm and 20.2 months (95% CI, 18.8 to 23.0) in the control arm (log-rank P = .002). Survival remained inferior after adjusting for baseline variables (hazard ratio, 1.33; P = .019). The two arms were similar in rates of total and serious adverse events. The most frequent adverse events were GI (reported in 75% of patients), and blood and lymphatic disorders (48%). Docetaxel toxicity leading to dose modification was more frequent in the ASCENT (31%) than in the control arm (15%).
Conclusion: ASCENT treatment was associated with shorter survival than the control. This difference might be due to either weekly docetaxel dosing, which, in a prior study, showed a trend toward inferior survival compared with an every-3-weeks regimen, or DN-101 therapy. +
Publication: Randomized, placebo-controlled trial of combined pentoxifylline and tocopherol for regression of superficial radiation-induced fibrosis +
Purpose: Radiation-induced fibrosis (RIF) is a rare morbid complication of radiotherapy, without an established method of management. RIF treatment with a combination of pentoxifylline (PTX) and alpha-tocopherol (vitamin E; Vit E) was recently prompted by the good results of a clinical trial and an animal study. The present double-blind, placebo-controlled, monocentric study was designed to assess the efficacy of this combination in treating RIF sequelae. Patients and Methods: Twenty-four eligible women with 29 RIF areas involving the skin and underlying tissues were enrolled from December 1998 to April 2000. These patients, previously irradiated for breast cancer, were randomly assigned to four balanced treatment groups: (A) 800 mg/d of PTX and 1,000 U/d of Vit E; (B) PTX plus placebo; (C) placebo plus Vit E; and (D) placebo-placebo. The main end point measure was the relative regression of measurable RIF surface after 6 months of treatment. Assessment was completed by depth (with ultrasonography) and associated symptom measures. Results: Twenty-two patients with 27 RIF areas were analyzed at 6 months. Mean RIF surface regression was significant with combined PTX/Vit E versus double placebo (60% ± 10% vs. 43% ± 17%; P = .038). The median slope for the speed of RIF surface area and volume regression was significantly higher for group A than groups B, C, and D. All treatments were well tolerated. Conclusion: Six months’ treatment of combined PTX/Vit E can significantly reduce superficial RIF. Synergism between PTX and Vit E is likely, as treatment with each drug alone is ineffective, but these results require confirmation in larger series. +
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). +
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 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. +
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 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.
Publication: Sativex oromucosal spray as adjunctive therapy in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy: two double-blind, randomized, placebo-controlled phase 3 studies +
Background: Opioids are critical for managing cancer pain, but may provide inadequate relief and/or unacceptable side effects in some cases.
Objective: To assess the analgesic efficacy of adjunctive Sativex (Δ9-tetrahydrocannabinol (27mg/mL): cannabidiol (25mg/mL)) in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy.
Methods: This report describes two phase 3, double-blind, randomized, placebo-controlled trials. Eligible patients had advanced cancer and average pain numerical rating scale (NRS) scores ≥4 and ≤8 at baseline, despite optimized opioid therapy. In Study-1, patients were randomized to Sativex or placebo, and then self-titrated study medications over a 2-week period per effect and tolerability, followed by a 3-week treatment period. In Study-2, all patients self-titrated Sativex over a 2-week period. Patients with a ≥15% improvement from baseline in pain score were then randomized 1:1 to Sativex or placebo, followed by 5-week treatment period (randomized withdrawal design).
Results: The primary efficacy endpoint (percent improvement (Study-1) and mean change (Study-2) in average daily pain NRS scores) was not met in either study. Post hoc analyses of the primary endpoints identified statistically favourable treatment effect for Sativex in US patients <65years (median treatment difference: 8.8; 95% confidence interval (CI): 0.00–17.95; p=0.040) that was not observed in patients <65years from the rest of the world (median treatment difference: 0.2; 95% CI: −5.00 to 7.74; p=0.794). Treatment effect in favour of Sativex was observed on quality-of-life questionnaires, despite the fact that similar effects were not observed on NRS score. The safety profile of Sativex was consistent with earlier studies, and no evidence of abuse or misuse was identified.
Conclusions: Sativex did not demonstrate superiority to placebo in reducing self-reported pain NRS scores in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy, although further exploration of differences between United States and patients from the rest of the world is warranted.
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 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.
Publication: Strahlentherapeutische Nebenwirkungen bei Abdominalkrebspatienten und deren Reduktion durch hydrolytische Enzyme +
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. +
Publication: Successful Treatment of Acute Radiation Proctitis with Aloe Vera: A Preliminary Randomized Controlled Clinical Trial +
Background: Acute radiation proctitis (ARP) is a common side-effect that affects up to 50% of patients receiving radiotherapy. The aim of this study was to evaluate the role of a topical preparation of Aloe vera in the treatment of ARP induced by radiotherapy of pelvic area. Subjects and Interventions: In this double-blind placebo-controlled trial, 20 consecutive patients with ARP after external-beam radiation therapy (46–72 Gy) of pelvic malignancies were randomized to receive either Aloe vera 3% or placebo ointment, 1 g twice daily for 4 weeks. These patients presented with at least two of the following symptoms: rectal bleeding, abdominal/rectal pain, diarrhea, or fecal urgency. These symptoms were rated by the patients in terms of their severity (grade 0–4) for each of the symptoms mentioned earlier at baseline and then weekly for 4 weeks. A symptom index was calculated by the addition of the scores (16 most symptomatic). Radiation Therapy Oncology Group (RTOG) acute toxicity criteria and psychosocial status of the patients were also recorded weekly. The lifestyle impact of the symptoms was assessed by questionnaire grading from 0 (no effect on daily activity) to 4 (afraid to leave home). Results: There was a significant (p<0.05) improvement in the symptom index (before treatment vs. after treatment with Aloe vera) for diarrhea (median score: 0.67 vs. 0.11), fecal urgency (median score: 0.89 vs. 0.11), clinical presentation total (median score: 4.33 vs. 1.22), RTOG total (median score: 2.89 vs. 0.89), and lifestyle (median score: 1.1 vs. 0.33). Hemorrhage and abdominal/rectal pain did not improve significantly. The odds ratios for advantage of Aloe vera over placebo for “clinical presentation total” and “RTOG total” were 3.97 (1.3–11.9) and 5.9 (1.6–21.6), respectively. Conclusion: A substantial number of patients with radiation proctitis seem to benefit from therapy with Aloe vera 3% ointment. +
Publication: The Effect of Aloe Vera Solution on Chemotherapy-Induced Stomatitis in Clients with Lymphoma and Leukemia: A Randomized Controlled Clinical Trial +
Background: Stomatitis is the most common complication of chemotherapy. This study aimed to
assess the effect of aloe vera solution on stomatitis and its pain intensity in patients undergoing chemotherapeutic procedures. Methods: In this randomized controlled clinical trial, 64 patients with Acute Myeloid Leukemia and Acute Lymphocytic Leukemia undergoing chemotherapy were randomly divided into a control and an intervention group. The intervention group patients were asked to wash their mouths with 5 ml of aloe vera solution for two minutes three times a day for 14 days. The control group patients, however, used only the ordinary mouthwashes recommended in hematologic centers. The patients’ mouths
were examined by two assistants on days 1, 3, 5, 7, and 14. The intensity of stomatitis was recorded according to WHO stomatitis intensity checklists and pain was evaluated using Visual Analog Scale. The data were analyzed by SPSS statistical software, version 18.
Results: The results showed that aloe vera solution mouthwash significantly reduced the intensity of stomatitis and its pain in the intervention group compared to the control group. On the first day, no significant difference was found between the two groups regarding the mean intensity of stomatitis (P=0.178) and pain (P=0.154). However, a significant difference was observed between the two groups in this regard on other days (days 3-14: P=0.001 for stomatitis intensity, P=0.001 for pain). Conclusions: Aloe vera solution can improve the patients’ nutritional status, reduce stomatitis and its
pain intensity, and increase the patients’ satisfaction. +
Publication: The Effect of Foot Reflexology on Anxiety and Pain in Patients With Breast and Lung Cancer. +
To test the effects of foot reflexology on anxiety and pain in patients with breast and lung cancer. Quasi-experimental, pre/post, crossover. A medical/oncology unit in a 314-bed hospital in the southeastern United States. Twenty-three inpatients with breast or lung cancer. The majority of the sample were female, Caucasian, and 65 years or older; had 12 or fewer years of education and an annual income of $20,000 or more; and were receiving regularly scheduled opioids and adjuvant medications on the control and intervention day. Procedures included an intervention condition (foot reflexology to both feet for 30 minutes total by a certified reflexologist) and a control condition for each patient (with at least a two-day break). No changes were made in patients' regular schedule or medications. Anxiety and pain. Following the foot reflexology intervention, patients with breast and lung cancer experienced a significant decrease in anxiety. One of three pain measures showed that patients with breast cancer experienced a significant decrease in pain. The significant decrease in anxiety observed in this sample of patients with breast and lung cancer following foot reflexology suggests that this may be a self-care approach to decrease anxiety in this patient population. Professionals and lay people can be taught reflexology. Foot reflexology is an avenue for human touch, can be performed anywhere, requires no special equipment, is noninvasive, and does not interfere with patients' privacy. +
Publication: The Effect of Reflexology on Chemotherapy-induced Nausea, Vomiting, and Fatigue on Breast Cancer Patients. +
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. +
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 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. +
Publication: The Indian Spice Turmeric Delays and Mitigates Radiation-Induced Oral Mucositis in Patients Undergoing Treatment for Head and Neck Cancer: An Investigational Study +
Purpose. Radiation-induced oral mucositis is an acute morbidity seen in patients undergoing treatment for head and neck cancers. In this study, we evaluated the efficacy of turmeric in preventing radiation-induced mucositis.
Methods. This was a single-blinded, randomized, controlled clinical trial and was conducted with head and neck cancer patients requiring 70 Gy of radiation or chemoradiotherapy (daily radiotherapy plus carboplatin once a week). Eligible patients (n = 80) were randomly assigned to receive either turmeric gargle (n = 40) or povidone-iodine ((n = 40) active comparator condition) during chemo/radiotherapy during the period of treatment. Oral mucositis was assessed using the RTOG (Radiation Therapy Oncology Group) grading system before the start, during, and at the end of the treatment by an investigator unaware of the treatment. The primary endpoint of this study was the incidence of mucositis every week during the 7-week period. The secondary endpoint was the effect of turmeric gargle on the incidence of treatment breaks, loss of scheduled treatment days, and decrease in body weight at the end of the treatment.
Results. This study clearly suggests that when compared with the cohorts using povidone-iodine gargle, the group using turmeric as a mouthwash had delayed and reduced the levels of radiation-induced oral mucositis and was statistically significant at all time points (P < 0.001 to P < 0.0001). Additionally, the cohorts using turmeric had decreased intolerable mucositis (P < 0.001) and lesser incidence of treatment breaks in the first half of the treatment schedule before 4 weeks (P < 0.01) and reduced change in body weight (P < 0.001).
Conclusions. Gargling with turmeric by head and neck cancer patients undergoing radiation therapy provided significant benefit by delaying and reducing the severity of mucositis. Turmeric is readily available, relatively inexpensive, and highly accepted making it useful in cancer treatment.
Publication: The Vitamin E Preventive Effect on Taxol-Induced Neuropathy Among Patients With Breast Cancer: A Randomized Clinical Trial +
Background: Chemotherapy-induced neuropathy is one of the most severe complications of cancer drug therapies causing a number of problems for patients and making treatment limitation decisions problematic. One of the most important drugs used in breast cancer chemotherapy regimens, Taxol is considered as the most common cause of neuropathy in such cases. The aim of this study was to evaluate the effect of vitamin E on reducing the Taxol-induced neuropathy development among patients with breast cancer.
Methods: The randomized clinical trial (RCT) included 70 patients with breast cancer who received Taxol chemotherapy regimens. They were assigned to one of the two groups: a group without vitamin E feeding (Group I) and a group with vitamin E treatment at a daily dose of 400 IU bid (Group II). Electrophysiological testing of all patients was performed before starting medications and again 3 months post-treatment. The data were compared between the groups.
Results: Vitamin E feeding had no significant effect on amplitude, latency, and CV of tibial and peroneal nerves (P > 0.05), while the delta amplitude of sural nerve was significantly lower among patients taking vitamin E supplements (P = 0.007).
Conclusion: We suggest the inhibitory effect of vitamin E on the progression of Taxol-induced neuropathy, by slowing the speed of progression, among breast cancer patients by improving the function of the nervous system. +
Publication: The chemopreventive effect of Ginkgo biloba extract 761 against cisplatin ototoxicity: a pilot study +
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. +
Publication: The effect of "curcuma Longa" topical gel on radiation -induced oral mucositis in patients with head and neck cancer +
Background: Different treatment and protective approaches for radiation-induced oral mucositis have been practiced and have varied success. Of which, radioprotective agents, synthetic or natural, have been of great interest for researchers. This study aims to evaluate the effect of curcuma longa topical gel as a herbal production on mucositis induced by radiation therapy of head and neck cancers.
Materials and Methods: Thirty-seven patients with head and neck cancer admitted for radiation therapy were selected. The patients were given curcuma longa or placebo topical gel for 8 weeks since the initiation of the radiotherapy, and were evaluated weekly for the presence and the extent of oral mucositis.
Results: No grade-3 mucositis was observed in patients who used curcuma longa topical gel, and the grade of the mucositis was significantly different between the two groups with better effects found in case group compared to controls. No significant difference between the case and control groups was observed when comparing the time of appearing the first signs of mucositis. Oral lesions in case group were significantly smaller than that of control group.
Conclusion: This study showed that the topical gel, containing curcuma longa’s derivative, can effectively reduce the oral symptoms of mucositis in patients undergoing head and neck cancer radiotherapy. This herbal drug improves the grade of mucositis and reduces the size of oral lesions resulting from radiotherapy to the head and neck region. +