Property:Authors Abstract
This is a property of type Text.
P
Publication: Effects of foot massage applied in two different methods on symptom control in colorectal cancer patients: Randomised control trial +
This randomized controlled clinical study aimed to determine the effect of 2 foot massage methods on symptom control in people with colorectal cancer who received chemoradiotherapy. Data were collected between June 16, 2015, and February 10, 2016, in the Department of Radiation Oncology of an oncology training and research hospital. The sample comprised 60 participants. Data were collected using an introductory information form, common terminology criteria for adverse events and European Organization for Research and Treatment of Cancer Quality of Life Questionnaires C30 and CR29. Participants were randomly allocated to 3 arms: classical foot massage, reflexology, and standard care control. The classical massage arm received foot massage using classical massage techniques, and the reflexology arm received foot reflexology focusing on symptom‐oriented reflexes twice a week during a 5‐week chemoradiotherapy treatment schedule. The control arm received neither classical massage nor reflexology. All patients were provided with the same clinic routine care. The classical massage was effective in reducing pain level and distension incidence while foot reflexology was effective in reducing pain and fatigue level, lowering incidence of distension and urinary frequency and improving life quality. +
Publication: Effects of ginger adjunct to the standard prophylaxis on reducing carboplatin and paclitaxel-induced nausea vomiting: a randomized controlled study +
Purpose: To determine effects of ginger on reducing the severity of nausea and/or vomiting among gynecologic cancer patients receiving a combined carboplatin-paclitaxel regimen.
Methods: The research was a randomized, double-blinded, crossover, placebo-controlled trial. Participants were patients with gynecologic malignancies receiving carboplatin-paclitaxel chemotherapy at King Chulalongkorn Memorial Hospital. Either ginger (2 g per day) or placebo was prescribed in adjunct to standard antiemetic prophylaxis, in alternated cycles between groups: in group 1, ginger was prescribed in odd cycles and placebo in even cycles and vice versa in group 2. Patients with gut obstruction or brain or bowel metastasis, those using anticoagulants or other ginger or antiemetic medications, or patients who had ginger allergy were excluded from the study. Statistics were analyzed by STATA version 15.1.
Results: Overall, 47 participants were recruited. Mean age was 53.9 years. Seventeen subjects were chemotherapy-naïve. In an acute phase of nausea, ginger therapy significantly reduced the mean nausea score comparing to placebo (P = 0.03). However, in
the delayed phase, there were no significant differences between groups. For the acute and delayed phase of vomiting, there was no difference between the groups. No serious adverse effects were demonstrated in the ginger group (P > 0.05).
Conclusion: Adjunct ginger therapy on standard nausea and vomiting prophylaxis protocol especially in day 1 has benefit in reducing an acute phase nausea in patients receiving a combined carboplatin-paclitaxel regimen. The benefit on delayed phase nausea and vomiting is still equivocal. +
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 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. +
Publication: Effects of vitamin A on survival in patients with chronic myelogenous leukemia: a SWOG randomized trial +
A national cooperative group trial was conducted in 153 patients with chronic myelogenous leukemia (CML) in chronic phase treated with oral pulse busulfan to determine if oral vitamin A can increase the time to blast crisis and enhance survival of patients. Patients diagnosed within 1 year and in the chronic phase of CML were randomized to receive oral pulse busulfan or the alkylator plus continuous oral vitamin A. Distributions of clinical progression and overall survival were estimated using the method of Kaplan and Meier. Associations of these endpoints with treatment and other patient characteristics were analyzed using the proportional hazards regression method of Cox. Both regimes were well tolerated. Patients in the busulfan plus vitamin A arm had somewhat longer durations of clinical progression-free survival (median 46 months) and overall survival (51 months) compared to those in the busulfan arm (medians 38 and 44 months). However, the differences were not statistically significant (one-tailed P = 0.11 for clinical progression-free survival, 0.081 for survival). After adjustment for significant factors identified in an additional exploratory multivariate analysis, risk of clinical progression or death was 53% (P = 0.022) greater and risk of death 60% (P = 0.014) greater among busulfan patients. Given the relatively large though non-significant difference between treatment arms, the limited statistical power of the study, and the likelihood that oral vitamin A may not be the most effective means of delivering retinoid therapy, we conclude that further investigation of retinoids in chronic phase CML is warranted. +
Publication: Effects of zinc sulfate supplementation on cell-mediated immune response in head and neck cancer patients treated with radiation therapy +
Zinc deficiency is an important factor that impairs cellular immunity and contributes to low T lymphocyte counts in head and neck cancers. Persistent T lymphopenia is clinically relevant in terms of tumor persistence and/or recurrence. The primary objective was to evaluate the impact of zinc sulfate supplementation on the absolute numbers of circulating T lymphocytes and T lymphocyte subpopulations. The secondary objectives were to evaluate overall survival, progression-free survival, and the adverse events of zinc sulfate. Seventy-two head and neck cancer patients were enrolled in a randomized, double-blind, placebo-controlled trial. Zinc sulfate 50 mg in 10 cc and an identically appearing placebo were self-administered 3 times daily at meal times. Blood samples were obtained for complete blood count, total T lymphocytes and T lymphocyte subpopulations before radiation therapy as baselines, at the fifth week during radiation therapy, and at the first month after completion of radiation therapy. The baseline characteristics of patients, tumors, and treatments and the baseline lymphocyte parameters were not significantly different between the 2 groups. Zinc sulfate supplementation during head and neck radiation therapy showed no increase in absolute numbers of circulating T lymphocytes, T lymphocyte subpopulations, or survival with acceptable side effects. +
Publication: Effects of zinc supplementation on clinical outcomes in patients receiving radiotherapy for head and neck cancers: a double-blinded randomized study +
Purpose: To evaluate the impact of zinc supplementation on the survival of patients after receiving radiotherapy for head and neck cancers.
Methods and Materials: Patients were randomly divided into two groups; experimental and control. Patients in the experimental group received a predetermined dose of a zinc supplement, and the control group, a placebo. The 50 patients in each group could be considered homogenous with respect to medical histories, tumor characteristics, and therapeutic details.
Results: Patients in both groups appeared to have similar results for 3-year overall, disease-free, and metastases- free survival rates (p = 0.19, p = 0.54, and p = 0.35, respectively). However, patients in the experimental group had better 3-year local-free survival (LFS), although the difference was only marginal (p = 0.092). Another difference was that patients in the experimental group with Stages III–IV disease had a much better 3-year LFS rate when they received concurrent chemoradiotherapy (p = 0.003).
Conclusions: One impact seen was that zinc supplementation improved LFS at 3 years after beginning treatment for patients with Stages III–IV disease. It is imperative that these patients be followed up for a longer period to draw a definite conclusion. +
Publication: Effects of zinc supplementation on fatigue and quality of life in patients with colorectal cancer +
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. +
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 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. +
Publication: Efficacy and tolerability of proteolytic enzymes as an anti-inflammatory agent in lymphoedema after axillary dissection due to mammary cancer +
Aim of the study was to investigate the influence of a proteolytic enzyme, the drug Wobenzym, (Mucos Emulsionsges. mbH, Wien. Austria), on the volume of the lmyphoedema in the limb and the fibrotic changes in the tissue in secondary lymphoedema patients after axillary lymph node dissection due to mammary cancer who received combined decongestive physical treatment (CDT). Methods: Randomised, placebo controlled, double blinded study, carried out over one year in a lymphoedema treatment centre. 88 patients have been included and analysed according to the blind review report using a univariate one sided Wilcoxon Mann Whitney test for differences for the primary criterion volume reduction (confirmatory analysis). The secondary variables CRP value in the blood, skinfold thickness, tension, and global judgement of efficacy by both the investigator and patient underwent exploratory interpretations. The visits for measurements were scheduled on the days 1, 9, 19 and 45, except for CRP measurement which was performed on days 1 and 19 only. The CDT was applied from day 1 through day 20.
Results: Volume: Starting with baseline measurement of the ill arm of a mean of 2483.0 (verum) and 2420.1 (placebo) both groups show a decrease of volume until day 45 with final means of 2275.1 (verum) and 2225.7 (placebo).
CRP: In patients with positive CRP-values at baseline there has been a mean percent change from baseline of minus 39.8% as compared to visit 3, while in the placebo group there has been a percent change of minus 17.4%.
Skinfold Thickness: A parameter for the fibrosis. Starting with baseline thickness in the lower arm of 3.7mm (verum) and 5.0mm (placebo) both groups show decrease of the thickness until day 45 with final means of 3.0mm (verum) and 4.0mm (placebo). The mean percent change at the final visit 4 from visit 3 was shown with -0.19% for the verum group. The placebo group showed a marginal mean increase at the visit 4 from visit 3 with +2.2%. Starting with a baseline thickness of the skin of the hand of 6.5mm (verum) and 4.3mm (placebo) both groups show decrease of the thickness until day 45 with final means of 3.8mm (verum) and 3.0mm (placebo). The verum group is showing a better development with regard to the means between visit 2 and visit 4. In the upper arm and the fingers no group difference in decreasing the skinfold thickness was shown.
Tension: It was assessed by the investigator by means of a 4-point scale. Starting with a baseline mean tension of 2.0 (verum) and 1.8 (placebo) both groups show a decrease of tension until visit 4 with final means of 0.4 (verum) and 0.5 (placebo).
Conclusion: For the primary criterion Volometer measurements the study failed to demonstrate efficacy of the test preparations Wobenzym. The difference in volume reduction between the two groups is negligible. Nevertheless, fibrotic changes have far better been reduced in the verum group, not from the very beginning of the treatment, but in the second half of the treatment, meaning that the result of the CDT maintains better. The inflammation related parameters (tension, CRP) have a better outcome in the verum group compared to the placebo. The CDT is the golden standard in lymphoedema treatment, an improvement by anti-inflammatory therapy with proteolytic enzymes seems to be possible.
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 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. +
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 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. +
Publication: Efficacy of Topical and Systemic Vitamin E in Preventing Chemotherapy-induced Oral Mucositis +
Background: There is still no consensus regarding the optimum treatment of chemotherapy-induced oral mucositis, and its management is still mainly supportive. Vitamin E has been shown to be effective in reducing the symptoms of oral mucositis. Objectives: The aim of this study was to assess the efficacy of prophylactic systemic and topical vitamin E in reducing the signs and symptoms of oral mucositis in patients receiving chemotherapy. Patients and Methods: We conducted a placebo-controlled randomized clinical trial among 76 patients with a hematologic malignancy treated with chemotherapy. Patients were randomly assigned into three groups: supplementation with vitamin E paste (group 1) and 200 mg/d vitamin E pills (group 2). Group 3 received placebo paste, identical in appearance and taste to the vitamin E paste, but consisting of the vehicle only. Patients were advised to use the administered medication from two days before each cycle of chemotherapy till at least 20 days after completion of each cycle. Oral exams were performed 10-14 days after each cycle of chemotherapy. Results: Patients in groups 2 and 3 did not show any difference in the degree of mucositis or severity of pain. However, after the second cycle, patients who were treated with topical vitamin E showed significantly less oral pain and had fewer cases of severe mucositis compared to groups 2 and 3. Conclusions: Topical vitamin E could be beneficial in reducing the severity of oral mucositis, but no therapeutic gain would be achieved by using systemic vitamin E in this regard. +
Publication: Efficacy of Vitamin A in the Prevention of Locoregional Recurrence and Second Primaries in Head and Neck Cancer +
Chemoprevention with retinoids is currently an experimental approach to prevent local relapses and second primaries in treated head and neck cancer patients. We evaluated the effectiveness of vitamin A in preventing the above events in a randomised trial involving 106 head and neck cancer patients who had achieved complete regression of their disease with radiotherapy and/or surgery. They were randomised to receive retinyl palmitate (200,000 IU per week for 1 year) or placebo. 50 subjects on vitamin A and 43 on placebo completed 1 year supplementation; 49 in the former group and 42 in the latter could be evaluated over a 3 year period from the initiation of the study. One fifth (11/56) of patients in the vitamin A group and one tenth (5/50) in the placebo group had loco-regional recurrence. The frequency of recurrences in stage I patients in the vitamin A group was higher compared to the placebo group, although it was not statistically significant. No second primaries were observed in the vitamin A group; 2 patients in the placebo group had second primaries. No clinically obvious side effects were observed with vitamin A. The higher frequency of recurrences in the vitamin A group is of concern although it may be a chance finding given the small size of the trial. The effect on second primaries is consistent with other observations reported in literature. +
Purpose: To investigate the efficacy and safety of Wobe-Mugos® E (proteolytic enzymes) for amelioration of early side effects of radiotherapy for head-and-neck tumors, particularly oral mucositis.
Patients and Methods: The study was a prospective, randomized, multicenter, placebo-controlled, triple-blind phase III study with parallel groups. 69 patients with carcinomas of the oropharynx or the oral cavity were enrolled between 1996 and 2000 in five centers; 54 of these were recruited in Dresden. Of the 69 patients, 61 (Dresden: 46) were available for analysis. The proteolytic enzymes tested (Wobe-Mugos® E) comprised papain 100 mg, trypsin 40 mg, and chymotrypsin 40 mg.
Results: Wobe-Mugos® E was well tolerated. For the maximum mucositis scores, no statistically significant differences were found between the placebo and the verum group. The average mucositis score over weeks 1–6 revealed a significant difference in favor of the placebo arm, based on an earlier onset of mucositis in the Wobe-Mugos® E group.
Conclusion: The present study failed to demonstrate any effect of treatment with Wobe-Mugos® E on radiotherapy side effects in patients treated for head-and-neck tumors. In particular, there was no beneficial effect on radiation-induced early oral mucositis. +
Publication: Efficacy of ginger for prophylaxis of chemotherapy-induced nausea and vomiting in breast cancer patients receiving adriamycin–cyclophosphamide regimen: a randomized, double-blind, placebo-controlled, crossover study +
Purpose: The purpose of this study is to determine the efficacy of ginger for reducing chemotherapy-induced nausea and vomiting (CINV) in breast cancer patients receiving adriamycin and cyclophosphamide (AC) regimens.
Methods: We enrolled breast cancer patients receiving AC who experienced moderate to severe nausea or vomiting during the first chemotherapy cycle. Subjects were randomized to receive a 500-mg ginger capsule or placebo twice a day for 5 days starting on the first day of the second AC cycle and were switched to the other treatment in the third cycle. All participants also received ondansetron and dexamethasone for CINV prophylaxis. Nausea severity was recorded once a day during the first 5 days of each cycle. The primary outcome was reduction in nausea score.
Results: Thirty-four subjects (68 cycles of AC) were enrolled. Mean (range) maximum nausea score in the first AC cycle was 58 (40–90). Thirty-three subjects (97 %) received the same AC doses in the second as in the third cycle. Mean (±standard error) maximum nausea scores in patients receiving ginger and placebo were 35.36 (±4.43) and 32.17 (±3.71), respectively. The difference in mean maximum nausea scores was 3 (95 % confidence interval, −3 to 9; P = 0.3). There were no significant differences between ginger and placebo in terms of vomiting incidence and severity, rescue medication use, chemotherapy compliance, and adverse events.
Conclusions: Ginger (500 mg) twice daily was safe, but conferred no additional benefit in terms of reducing nausea sever- ity in breast cancer patients receiving AC and ondansetron and dexamethasone for CINV prophylaxis. +
Publication: Efficacy of hydrolytic enzymes in preventing radiation therapy-induced side effects in patients with head and neck cancers +
Purpose: Based on in vitro and on clinical evidence of protection against acute side effects of radiation, a prospective randomized, open study was performed to determine the efficacy of an oral proteolytic enzyme preparation in patients with head and neck cancer receiving conventional fractionated radiation therapy.
Methods: Patients with stage T3/T4 head and neck cancer were eligible. One hundred patients from two centres were entered into the study. 60Co gamma-radiation was delivered at a standard daily radiation dose of 2 Gy in 25–35 fractions over a period of 6–7 weeks. Two lateral parallel opposing fields were used with a portal area of 10 × 15 cm. Patients assigned to the test group arm additionally received enzyme tablets orally t.i.d. starting 3 days prior to radiation therapy, and continuing up to 5 days after completion of the course of radiation therapy. Patients in the control arm were not given any drug or placebo. Acute radiation side effects were described as mucositis, skin reaction, dysphagia, and were graded at each visit during and after radiation therapy, following RTOG/EORTC criteria.
Results: The severity (maximum extent) of acute radiation therapy side effects was significantly less in enzyme-treated patients than in control patients: mucositis (mean: 1.3 vs 2.2, P < 0.001), skin reaction (1.2 vs 2.4, P < 0.001) and dysphagia (1.4 vs 2.2, P < 0.001). The duration of these side effects as well as the sum scores of side effects were also less in the study arm. Conclusions: Combination of enzyme therapy with conventional fractionated radiation therapy was feasible and well-tolerated. There was significant protection against acute side effects of radiation therapy in the study arm. Not only was the severity of acute side effects less but the duration was shorter and the time to onset was also delayed. Prospective randomized double-blind studies would verify this role of an oral enzyme therapy as standard co-medication with radiation therapy to the head and neck region.
Publication: Evaluating the Effect of Zingiber Officinalis on Nausea and Vomiting in Patients Receiving Cisplatin Based Regimens +
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. +
Publication: Evaluation of the cardioprotective effects of l-carnitine and silymarin in cancer patients receiving anthracycline-containing chemotherapy +
Aim: Anthracycline-induced cardiotoxicity is the most common constraint of its use in the treatment of various types of cancer. This study aimed to investigate the benefits of the addition of the l-carnitine / silymarin to anthracycline chemotherapy in patients with breast cancer.
Methods: 83 patients were recruited from Clinical Oncology Department, Tanta University, Egypt, then prospectively randomized to receive their anthracycline-containing therapeutic regimen, control group (n=33), or anthracycline plus l-carnitine, l-carnitine group (n=25), or anthracycline plus silymarin, silymarin group (n= 25). Blood samples were collected at the beginning and after 6 months to measure LDH, CK-MB, cTn I, Anticardiolipin IgG, Fe, ferritin, and TIBC and % of saturation. % EF was documented. Data were statistically analyzed by ANOVA and paired t-test. P <0.05 was statistically significant.
Results: The addition of l-carnitine to anthracycline chemotherapy has a significantly improved EF% (P=0.003), Anticardiolipin IgG (P=0.001), ferritin (P=0.001), and TIBC (P=0.011). The supplementation with silymarin to anthracycline chemotherapy had a statistically significant decrease in Anticardiolipin IgG (P=0.000), iron (P=0.001), ferritin (P= 0.001), TIBC (P=0.007), and % saturation (P=0.001). Silymarin group showed a significant decrease in iron profile compared to the l-carnitine group.
Conclusion: The co-administration of l-carnitine or silymarin with anthracycline chemotherapy represents a new therapeutic strategy for better control of anthracycline-induced cardiotoxicity. Silymarin resulted in more beneficial effects on the iron profile compared to l-carnitine with anthracycline or anthracycline chemotherapy alone. +
Publication: Evaluation of the efficacy of zinc sulfate in the prevention of chemotherapy-induced mucositis: A double-blind randomized clinical trial +
BACKGROUND: Oral mucositis is a serious complication of chemotherapy that results in painful debilitating inflammation, necessitating the administration of analgesics. There is no cure for mucositis. Some studies have evaluated the effect of zinc sulfate on mucositis. The present study aims to evaluate the effect of oral zinc sulfate on prevention of mucositis, xerostomia, and pain induced by chemotherapy. METHODS: This double-blind, randomized controlled trial was carried out on 50 adult patients who underwent chemotherapy during 2008-2009. Patients were divided in two groups. Patients in the intervention group were administered three, 220 mg zinc sulfate capsules daily until the end of their chemotherapy treatment. Patients in the placebo group received three placebo capsules daily, which were similar in shape, taste, and color to the zinc sulfate capsules. Data were analyzed by SPSS version 17 software, using the independent samples t-test, Mann-Whitney U and Friedman tests. RESULTS: The incidence of grade 3 mucositis was lower in the zinc sulfate group. In the first follow up, grade 3 mucositis was detected in 10% of patients. In the placebo group, grade 3 mucositis was seen in 46.6% of patients. By the fourth follow up, grade 3 mucositis was detected in 3.33% of patients in the intervention group and in 20% of patient in the placebo group. At the end of the study there was no grade 3 mucositis detected in the zinc sulfate group, whereas there were 3.57% of patients in the placebo group with grade 3 mucositis. The results also showed that zinc sulfate decreased the effects of xerostomia and pain in patients under chemotherapy treatment. CONCLUSION: It can be concluded that zinc sulfate might decrease the intensity of mucositis. +
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. +