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Publication: Dronabinol Versus Megestrol Acetate Versus Combination Therapy for Cancer-Associated Anorexia: A North Central Cancer Treatment Group Study +
Purpose: To determine whether dronabinol administered alone or with megestrol acetate was more, less, or equal in efficacy to single-agent megestrol acetate for palliating cancer-associated anorexia.
Patients and Methods: Four hundred sixty-nine assessable advanced cancer patients were randomized to (1) oral megestrol acetate 800 mg/d liquid suspension plus placebo, (2) oral dronabinol 2.5 mg twice a day plus placebo, or (3) both agents. Eligible patients acknowledged that loss of appetite or weight was a problem and reported the loss of 5 pounds or more during 2 months and/or a daily intake of less than 20 calories/kg of body weight.
Results: Groups were comparable at baseline in age, sex, tumor type, weight loss, and performance status. A greater percentage of megestrol acetatetreated patients reported appetite improvement and weight gain compared with dronabinol-treated patients: 75% versus 49% (P = .0001) for appetite and 11% versus 3% (P = .02) for > 10% baseline weight gain. Combination treatment resulted in no significant differences in appetite or weight compared with megestrol acetate alone. The Functional Assessment of Anorexia/Cachexia Therapy questionnaire, which emphasizes anorexia-related questions, demonstrated an improvement in quality of life (QOL) among megestrol acetate–treated and combination-treated patients. The single-item Uniscale, a global QOL instrument, found comparable scores. Toxicity was also comparable, with the exception of an increased incidence of impotence among men who received megestrol acetate.
Conclusion: In the doses and schedules we studied, megestrol acetate provided superior anorexia palliation among advanced cancer patients compared with dronabinol alone. Combination therapy did not appear to confer additional benefit. +
Publication: EUROSCAN, a Randomized Trial of Vitamin A and N-Acetylcysteine in Patients With Head and Neck Cancer or Lung Cancer +
Background: Preclinical evidence suggests that retinoids and antioxidants may prevent or delay the occurrence of cancer in the upper or lower airways, but such effects have not been reliably established in clinical studies. To assess the chemopreventive effects of vitamin A (retinyl palmitate) and N-acetylcysteine, we conducted a large randomized intervention study in patients with head and neck cancer or with lung cancer, most of whom had a history of smoking.
Methods: From June 1988 through July 1994, a total of 2592 patients (60% with head and neck cancer and 40% with lung cancer) were randomly assigned to receive 1) retinyl palmitate (300000 IU daily for 1 year followed by 150000 IU for a 2(nd) year), 2) N-acetylcysteine (600 mg daily for 2 years), 3) both compounds, or 4) no intervention. All statistical tests were two-sided.
Results: Of the patients, 93.5% had smoked tobacco at sometime in their lives (and 25% continued to smoke after cancer diagnosis). After a median follow-up of 49 months, 916 patients were reported with an event (recurrence, second primary tumor, or death). No statistically significant difference was observed in overall survival or event-free survival between patients who received retinyl palmitate and patients who did not. Similarly, no difference was seen in overall survival or event-free survival between patients who received N-acetylcysteine and patients who did not. There was a lower incidence of second primary tumors in the no intervention arm, but the difference was not statistically significant.
Conclusion: A 2-year supplementation of retinyl palmitate and/or N-acetylcysteine resulted in no benefit-in terms of survival, event-free survival, or second primary tumors-for patients with head and neck cancer or with lung cancer, most of whom were previous or current smokers. +
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 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. +
Publication: Effect of Ginger Tea on Chemotherapy-Induced Nausea and Vomiting among Patients Attending the Oncology Teaching Hospital, Baghdad 2020 +
Background: Ginger has been widely used to relieve nausea and vomiting in several settings, one of them, patients receiving chemotherapy. This study was done to assess the effect of ginger in controlling the chemotherapy induced nausea and vomiting (CINV) among patients.
Methods: An interventional (pre-post) study design was conducted in oncology teaching hospital in Baghdad for three months. Sixty participants were randomly assigned into intervention group (30 participants received ginger tea (1.5 g/d) with routine antiemetic regimen for the first 5 days of the chemotherapy cycle) and control group (30 participants received only routine antiemetic regimen). MASCC Antiemesis Tool (MAT) was used for assessment of CINV in cancer patients before and after the use of ginger tea.
Results: No significant difference was observed between the intervention and control groups in the acute and delayed phases of CINV after intervention with ginger tea(p >0.05), but difference between the study groups was found statistically significant (p <0.05)regarding the severity of nausea postchemotherapy.
Conclusions: The addition of ginger tea to routine antiemetic regimen in patients receiving chemotherapy effectively reduced the severity of nausea. However, there is no additional role for ginger in reducing the acute and delayed phases of CINV. +
Publication: Effect of Ginger and Chamomile on Nausea and Vomiting Caused by Chemotherapy in Iranian Women with Breast Cancer +
Background: Chemotherapy-induced nausea and vomiting (CINV) places a significant burden on the patient. Herbal agents are the most commonly complementary therapies used among the public. This study was done to determine the effect of ginger and chamomile capsules on nausea and vomiting in cases undergoing chemotherapy for breast cancer (BC).
Materials and Methods: In a randomized, double-blind and clinical trial study, 65 women with BC undergoing chemotherapy were referred to Breast Cancer Research Center, Tehran, Iran, between May 2013 to June 2014. Regimen for ginger group for 5 days before and 5 days after chemotherapy was: 2 times a day and 500 mg capsules of powdered ginger root in addition to a routine antiemetic regimen consisting of dexamethasone, metoclopramide and aprepitant (DMA) capsules. Chamomile group similarly was: 2 times a day and 500 mg capsules of Matricaria chamomilla extract in addition to a routine antiemetic regimen consisting of DMA capsules. Control group, routine antiemetic regimen consisting of DMA capsules.
Results: There were no significant differences between the ginger, chamomile and control groups regarding age. Drugs used for chemotherapy were identical and duration of disease was also matched (1-4 months). Ginger and chamomile were both significantly effective for reducing the frequency of vomiting, there being no significant difference between the ginger and chamomile groups. Moreover, unlike the chamomile, ginger significantly influenced the frequency of nausea.
Conclusions: According to the findings of this study, it should be declared that taking ginger capsules (1 g/day) might relieve CINV safely. Nurses dealing directly with cancer patients should be responsible for providing educational programs for patients and their families about how to deal with their drug regimens and associated side effects. +
Publication: Effect of Ginger on Acute and Delayed Chemotherapy-Induced Nausea and Vomiting: A Pilot, Randomized, Open-Label Clinical Trial +
Background. Nausea and vomiting are among the most prevalent and disturbing side effects of chemotherapy. Therefore, there is a need for additional antiemetic agents that could effectively reduce chemotherapy-induced nausea and vomiting (CINV), whether alone or in combination with current standard therapies. Since clinical data on the effectiveness of ginger in patients with advanced breast cancer is lacking, the present study aimed to evaluate the effects of ginger against both acute and delayed forms of CINV in a population with advanced breast cancer as the main malignancy.
Methods. In this pilot, randomized, open-label clinical trial, 100 women (mean age = 51.83 ± 9.18 years) with advanced breast cancer who were initially assigned to standard chemotherapy protocol with docetaxel, epirubicin, and cyclophosphamide (the TEC regimen) were randomized to receive ginger (1.5 g/d in 3 divided doses every 8 hours) plus standard antiemetic regimen (granisetron plus dexamethasone; the ginger group) or standard antiemetic regimen alone (control group). The duration of treatment with ginger was specified to 4 days from the initiation of chemotherapy. Prevalence, score, and severity of nausea, vomiting, and retching were assessed using a simplified form of Rhodes index in the first 6 hours, between 6 to 24 hours, and days 2, 3, and 4 postchemotherapy.
Results. A significantly lower prevalence of nausea was observed in the ginger group during 6 to 24 hours postchemotherapy. Despite this effect, no other significant additional benefit from ginger (1.5 g/d) was observed against prevalence or severity of nausea, vomiting, and retching in any of the assessed periods.
Conclusion. Addition of ginger (1.5 g/d) to standard antiemetic therapy (granisetron plus dexamethasone) in patients with advanced breast cancer effectively reduces the prevalence of nausea 6 to 24 hours postchemotherapy. However, there is no other additional advantage for ginger in reducing prevalence or severity of acute or delayed CINV.
Publication: Effect of High-Dose vs Standard-Dose Vitamin D3 Supplementation on Body Composition among Patients with Advanced or Metastatic Colorectal Cancer: A Randomized Trial +
Skeletal muscle and adipose tissue express the vitamin D receptor and may be a mechanism through which vitamin D supplementation slows cancer progression and reduces cancer death. In this exploratory analysis of a double-blind, multicenter, randomized phase II clinical trial, 105 patients with advanced or metastatic colorectal cancer who were receiving chemotherapy were randomized to either high-dose vitamin D3 (4000 IU) or standard-dose (400 IU) vitamin D3. Body composition was measured with abdominal computed tomography at enrollment (baseline) and after cycle 8 of chemotherapy (16 weeks). As compared with standard-dose vitamin D3, high-dose vitamin D3 did not significantly change body weight (−0.7 kg; (95% CI: −3.5, 2.0)), body mass index (−0.2 kg/m<sup>2</sup>; (95% CI: −1.2, 0.7)), muscle area (−1.7 cm<sup>2</sup>; (95% CI: −9.6, 6.3)), muscle attenuation (−0.4 HU; (95% CI: −4.2, 3.2)), visceral adipose tissue area (−7.5 cm<sup>2</sup>; (95% CI: −24.5, 9.6)), or subcutaneous adipose tissue area (−8.3 cm<sup>2</sup>; (95% CI: −35.5, 18.9)) over the first 8 cycles of chemotherapy. Among patients with advanced or metastatic colorectal cancer, the addition of high-dose vitamin D3, vs standard-dose vitamin D3, to standard chemotherapy did not result in any changes in body composition. +
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, 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 D<sub>3</sub> (median follow-up, 22.9 months), the median PFS for high-dose vitamin D<sub>3</sub> 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 D<sub>3</sub> (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 D<sub>3</sub> 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 D<sub>3</sub> was 16.1 ng/mL vs 18.7 ng/mL for standard-dose vitamin D<sub>3</sub> (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 D<sub>3</sub> 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.
Publication: Effect of Selenium on Incidence and Severity of Mucositis during Radiotherapy in Patients with Head and Neck Cancer +
Purpose: Oral mucositis (OM) is the most frequent side effect of radiation. Selenium deficiency leads to increased levels of free oxygen radicals and the selenium level tends to fall during radiotherapy. Hence, in this double-blind randomised controlled clinical trial, the effect of selenium was assessed in patients receiving radiation.
Materials and methods: Patients with head and neck cancer who were candidates to receive radiation were instructed to use selenium 200 mcg tablets twice daily. The grade of OM was evaluated by the World Health Organization (WHO) grading system on a weekly basis. The selenium level was measured at baseline and at the end of the radiation.
Results: Seventy-one patients with head and neck cancer (37 in the selenium group, 34 in the placebo group) were enrolled in the study. The cumulative incidence of OM (grade 1-4) was 97.3% in the selenium and 100% in placebo group (p value: 0.79), and difference in the mean serum selenium level at the end of radiation was not statistically significant between the two groups (p value 0.24) Conclusion: Selenium supplementation does not appear to affect the selenium level as well as the severity and duration of OM. It is supposed that higher doses may be effective in the prevention of RT-mucositis. This trial was registered in the Iranian Registry of Clinical Trials accessible at www.irct.ir (ID No. IRCT2014072718612N1). +
Publication: Effect of Vitamin D Supplementation on Postcraniotomy Pain After Brain Tumor Surgery: A Randomized Clinical Trial +
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. +
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 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.
Publication: Effect of Vitamin E on Oxaliplatin-induced Peripheral neuropathy Prevention: A Randomized Controlled Trial +
Background: Peripheral neuropathy is one of the most important limitations of oxaliplatin base regimen, which is the standard for the treatment of colorectal cancer. Evidence has shown that Vitamin E may be protective in chemotherapy‑induced peripheral neuropathy. The aim of this study is to evaluate the effect of Vitamin E administration on prevention of oxaliplatin‑induced peripheral neuropathy in patients with colorectal cancer.
Methods: This was a prospective randomized, controlled clinical trial. Patients with colorectal cancer and scheduled to receive oxaliplatin‑based regimens were enrolled in this study. Enrolled patients were randomized into two groups. The first group received Vitamin E at a dose of 400 mg daily and the second group observed, until after the sixth course of the oxaliplatin regimen. For oxaliplatin‑induced peripheral neuropathy assessment, we used the symptom experience diary questionnaire that completed at baseline and after the sixth course of chemotherapy. Only patients with a score of zero at baseline were eligible for this study.
Results: Thirty‑two patients were randomized to the Vitamin E group and 33 to the control group. There was no difference in the mean peripheral neuropathy score changes (after − before) between two groups, after sixth course of the oxaliplatin base regimen (mean difference (after − before) of Vitamin E group = 6.37 ± 2.85, control group = 6.57 ± 2.94; P = 0.78). Peripheral neuropathy scores were significantly increased after intervention compared with a base line in each group (P < 0.001).
Conclusions: The results from this current trial demonstrate a lack of benefit for Vitamin E in preventing oxaliplatin‑induced peripheral neuropathy. +
Publication: Effect of Zinc Supplementation on Serological Response to Vaccination Against Streptococcus Pneumoniae in Patients Undergoing Chemotherapy for Colorectal Cancer +
The aim of the study was to evaluate the effect of zinc supplementation on the antibody titer and the 23-valent pneumococcal seroconversion after vaccination in patients undergoing chemotherapy for colorectal cancer. The study included 25 patients undergoing postsurgery chemotherapy for colorectal adenocarcinoma (chemo group). Subjects were assessed in the perioperative period (prevaccination), before chemotherapy (4th wk) and after 3 cycles of chemotherapy (16th wk). Thirty-two healthy volunteers (control group) were included in the study. Participants received the 23-valent pneumococcal conjugate vaccine, and capsules containing zinc (Zn) sulfate (70 mg daily) or identical placebo capsules (containing wheat starch with no added Zn) for 16 wk and were randomly allocated on one of the following groups: chemo-Zn (n = 10), chemo-placebo (n = 15), control-Zn (n = 21), and control-placebo (n = 11). The antipneumococcal antibody titer against 6 polysaccharides was analyzed by ELISA and compared using linear mixed models. The seroconversion rate was compared using Fisher's exact test. An immune response to the vaccination against pneumococcus was observed in all participants. In the 16th wk, the polysaccharide 6 concentration was lower in the chemo-Zn group (2.96 (1.74-5.03) mug/mL) compared with the Chemo-Placebo group (10.75 (5.37-21.54) mug/mL) and the seroconversion rate was lower in the chemo-placebo (36%) compared with the control-placebo (85%) (p = 0.027). Zinc supplementation did not change the antibody titer after vaccination. However, the lower seroconversion rate observed in the chemo-placebo suggests an influence of zinc in the vaccinal protection. +
Publication: Effect of herbal therapy to intensity chemotherapy-induced nausea and vomiting in cancer patients +
Background: Chemotherapy-induced nausea and vomiting are the most important complications for cancer patients as its prevalence has been reported to be about 54-96 percent. ginger has been used for medicinal purposes including nausea and vomiting in traditional Persian, Chinese and Indian pharmacopoeia.
Objectives: The objective of this study was to evaluate the efficacy of complimentary ginger among cancer patients experiencing nausea and vomiting.
Material and Methods: A randomized cross-over clinical trial was carried out on patients under chemotherapy treatment for at least 2 episodes of chemotherapy and at least 2 episodes of previous experience of nausea and vomiting. Subjects of this study received 2 different complementary regimes with 250mg ginger capsule in regime A and placebo capsule in regime B. subjects of the study were crossed over to receive the other regime during the two cycles of chemotherapy.
Results: Findings of the study indicated that subjects receiving ginger showed significant reduction in frequency and intensity of nausea and vomiting compared to placebo receiving subjects.
Conclusions: According to finding of this study, in accordance to most of other researches, ginger is an effective agent to reduce chemotherapy- induced nausea and vomiting. However, there are some researches supporting ginger as a moderate antiemetic agent among cancerous patients under chemotherapy. +
Publication: Effect of high-dose sodium selenite therapy on polymorphonuclear leukocyte apoptosis in non-Hodgkin's lymphoma patients +
The present study was undertaken to explore the effect of the administration of high doses of sodium selenite on apoptosis in polymorphonuclear leukocytes in patients with non-Hodgkin’s lymphoma. Thirty patients with newly diagnosed non-Hodgkin’s lymphoma were randomly divided into two arms. Arm I was treated with chemotherapy and arm II received 0.2 mg/kg/d sodium selenite in addition to chemotherapy. Flow cytometry was used for the monitoring of apoptosis on peripheral blood neutrophils at the time of diagnosis and after treatment in both arms of patients. Sodium selenite administration resulted in a significant reduction in neutrophils apoptosis (82±10% vs 32 ± 18%, p <0.05) and this was associated with significant reduction in infection rate following chemotherapy (67% vs 20%, p <0.05). Also, significant improvement in cardiac ejection fraction was observed (62 ± 4% vs 69 ± 5% p <0.05). It is concluded that sodium selenite administration at the dosage chosen acts as a cytoprotective agent, alleviating side effects and immunosuppressive effects of cytotoxic chemotherapeutic agents. +
Publication: Effect of intravenous high dose Vitamin C on postoperative pain and morphine use after laparoscopic colectomy: A randomized controlled trial +
Background and Objective. Vitamin C has antioxidant, neuroprotective, and neuromodulating effects. Recently, it showed antinociceptive effect as a result of the antioxidant properties.Therefore, we designed this study to assess the effect of intravenous vitamin C on opiate consumption and pain in patients undergoing laparoscopic colectomy. Methods. A total of 100 patients were enrolled and allocated to receive 50mg/kg vitamin C or placebo by intravenous infusion immediately after induction of anesthesia. Morphine consumption and scores of pain were assessed at 2, 6, and 24 h after completion of surgery. Results. There were 97 patients included in the analysis. Patients who received vitamin C had higher plasma concentrations of vitamin C at the end of surgery, significantly lower morphine consumption at the 2 h after end of surgery, and significantly lower pain scores at rest during first 24 h postoperatively. There was no significant difference between groups in side effects, fatigue score, or pain score during cough. Conclusion.This study shows high dose vitamin C infusion decreased postoperative pain during the first 24 h and reduced morphine consumption in the early postoperative period. Additional research needed to examine whether higher doses of vitamin C and longer infusion times can amplify these effects. +
Publication: Effect of vitamin E on chemotherapy-induced mucositis and neutropenia in leukemic patients undergoing bone marrow transplantation +
Aim: This study was conducted to investigate the effect of oral vitamin E on mucositis and neutropenia in patients with leukemia.
Methods: This was a randomized double-blind placebo controlled clinical trial of 60 patients with leukemia (acute lymphoblastic, acute myelogenous leukemia and chronic myelogenous leukemia) who were consecutive recipients of allogenic bone marrow transplantation (BMT), randomly assigned to receive 400 mg vitamin E twice daily (supplemented group) or placebo (control). The incidence and severity of mucositis and the mean duration of neutropenia were compared.
Results: The mean duration of neutropenia and the incidence of mucositis between the two groups were the same (P = 1.0). The difference between the placebo group and mucositis grade 1 (P = 0.31), grade 2 (P = 0.25), grade 3 (P = 0.93), and grade 4 (P = 0.32) was not statistically significant. Moreover, the variables of age, sex, BMI, and underlying disease had no effect.
Conclusion: In this study, supplementation with oral vitamin E had no effect on mucositis and neutropenia in patients with leukemia who were recipients of allogenic BMT. More interventional trials are warranted. +
Publication: Effectiveness of Guarana (Paullinia cupana) for Postradiation Fatigue and Depression Results of a Pilot Double-Blind Randomized Study +
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. +
Publication: Effects of High-Dose Vitamin D Supplementation on Phase Angle and Physical Function in Patients with Prostate Cancer on ADT +
Purpose: Androgen deprivation therapy (ADT) is commonly used to treat patients with advanced prostate cancer but is associated with functional decline. Bioelectrical impedance analysis (BIA)derived phase angle may reflect frailty and functional decline in cancer patients. High-dose vitamin D supplementation may improve phase angle values and physical function.
Methods: We conducted an exploratory analysis from a phase II randomized controlled trial investigating the efficacy of high-dose vitamin D supplementation in prostate cancer patients (age ≥ 60 yrs). Fifty-nine patients were randomized to high-dose vitamin D (600 IU/day plus 50,000 IU/week) or low-dose: RDA for vitamin D (600 IU/day plus placebo weekly) for 24 weeks. Phase angle was measured by BIA. Physical function measures included handgrip strength, 6-minute
walk test, Short Performance Physical Battery and leg extension. All testing was completed at baseline, week 12 and week 24.
Results: Phase angle values were wider over the entire study in the high-dose vitamin D arm indicating healthier muscle cells. The low-dose vitamin D arm had phase angle values consistent with frailty cutoffs in older men (< 5.7°).
Conclusion: Patients in the high-dose vitamin D arm experienced wider phase angle values over
the course of the study which may indicate less frailty. +
Publication: Effects of Reflexotherapy on Acute Postoperative Pain and Anxiety Among Patients With Digestive Cancer. +
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. +