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Evaluating the possible effect of melatonin on oxaliplatin-induced peripheral neuropathy

ABSTRACT: Intervention 1: Intervention group: Treatment with melatonin will be started on the evening of the first chemotherapy dose and continue through 1 month following the last dose of chemotherapy or 6 months after starting melatonin (each one goes earlier). During this period, patients will consume 20 mg of melatonin (4 capsules, each one contains 5mg melatonin) every evening. Melatonin capsule will be supplied by Zahravi Pharmaceutical Company. Intervention 2: Control group: Treatment with melatonin will be started on the evening of the first chemotherapy dose and continue through 1 month following the last dose of chemotherapy or 6 months after starting melatonin/placebo (each one goes earlier). During this period, patients will consume 4 capsules of placebo every evening. Placebo capsules will be supplied by Zahravi Pharmaceutical Company and will be the same as melatonin. Primary outcome(s): Percent of grade 2 and 3 neuropathy according to National Cancer Institute’s Common Toxicity Criteria for adverse events (NCI-CTCAE V.4) will be compered among the two study groups (case and control), as the main outcome of the study. Timepoint: Prior to the start of study; during the chemotherapy (prior to receiving each cycle); 1 month after receiving the last dose of chemotherapy or 6 months after initiation of melatonin (each one happens earlier). Method of measurement: National Cancer Institute’s Common Toxicity Criteria for adverse events (NCI-CTCAE V.4) scale will be used by the oncologist to evaluate severity of neuropathy in the patients. According to this scale severity of neuropathy will be classified from 1 to 5. Study Design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization will be done by block-permutation method, considering 8 blocks, each one consisting 10 patients. Random Allocation software will be used to allocate patients to drug or placebo group. Randomization and allocation will be done by one of the researchers who has no role in the treatment and evaluation of the patients, and also analysis of data, Blinding description: Randomization and allocation will be done by one of the researchers who has no role in the treatment and evaluation of the patients, and also analysis of data. Drug (melatonin) and placebo packaging will be similar and will not be distinguishable by physician and patients who receive them. During the study, melatonin and placebo will be supplied by the same company.

DISEASE(S): Drug-induced Polyneuropathy,Oxaliplatin-induced Peripheral Neuropathy

PROVIDER: 2492862 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Intervention 1: Intervention group: Subjects in the intervention group receive curcumin-piperine capsules (daily intake of 500 mg curcumin plus 5 mg piperine) for 8 weeks (n=36). The participants take one capsule every day, which was contained in an unlabeled bottle. Capsules are from Sami Labs company (Bangalore, India). Intervention 2: Control group: Placebo capsules are prepared by a similar company and are similar to the curcumin capsules regarding the color, shape and size. The control group receive a placebo capsule containing lactose plus 5 mg piperine for a period of 8 weeks (n=36). The participants take one capsule every day, which was contained in an unlabeled bottle. Capsules are from Sami Labs company (Bangalore, India). Primary outcome(s): Tumor necrosis factor alpha. Timepoint: Before the intervention and 8 weeks after taking drug or placebo. Method of measurement: Sandwich and competitive chemiluminescence immunoassays.;Interleukin 6. Timepoint: Before the intervention and 8 weeks after taking drug or placebo. Method of measurement: Sandwich and competitive chemiluminescence immunoassays.;Total quality of life score. Timepoint: Before the intervention and 8 weeks after taking drug or placebo. Method of measurement: Using EORTC QLQ questionnaire. Study Design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were randomly assigned to one of the treatment groups based on random allocation sequence generated by a statistician: 1) Drug: a group receiving liposomal curcumin capsules (500 mg/day) for 8 weeks (n=36), 2) Placebo: the control group who taking a placebo capsule for a period of 8 weeks (n=36).The tables of the Fleiss book were used to generate the random allocation sequence. The allocation scheme was consecutively numbered in envelopes which opened sequentially by an independent person, not involved in the study, Blinding description: All volunteers, care providers and statistician were blinded after assignment to intervention. So that, the capsules containers were coded as A and B by a non-researcher person and remained confidential until statistical analysis. The placebo capsules were similar to the drugs regarding the weight and c

Project description:Intervention 1: group two take a combination of probiotic and honey (two probiotic capsules and 30 grams honey per day, one capsule and 15 grams honey in the morning after breakfast and another one capsule in the evening, and 15 grams honey at night). Intervention 2: group three are the control group receive two placebo capsules (containing 500 mg of corn starch) per day, one capsule in the morning after breakfast and another one in the evening. Intervention 3: group one take probiotics )contained: Lactobacillus casei 1.5 × 109 CFU, Lactobacillus acidophilus 1.5 × 1010 CFU, Lactobacillus rhamnosus 3.5 × 109 CFU, Lactobacillus bulgaricus 2.5 × 108 CFU, Bifidobacterium breve 1 × 1010 CFU, Bifidobacterium longum 5 × 108 CFU and Streptococcus thermophilus 1.5 × 108 CFU per 500 mg(; two probiotic capsules per day, one capsule in the morning after breakfast and another one in the evening.;Treatment - Drugs;Treatment - Drugs;Treatment - Drugs;group two take a combination of probiotic and honey (two probiotic capsules and 30 grams honey per day, one capsule and 15 grams honey in the morning after breakfast and another one capsule in the evening, and 15 grams honey at night);group three are the control group receive two placebo capsules (containing 500 mg of corn starch) per day, one capsule in the morning after breakfast and another one in the evening;group one take probiotics )contained: Lactobacillus casei 1.5 × 109 CFU, Lactobacillus acidophilus 1.5 × 1010 CFU, Lactobacillus rhamnosus 3.5 × 109 CFU, Lactobacillus bulgaricus 2.5 × 108 CFU, Bifidobacterium breve 1 × 1010 CFU, Bifidobacterium longum 5 × 108 CFU and Streptococcus thermophilus 1.5 × 108 CFU per 500 mg(; two probiotic capsules per day, one capsule in the morning after breakfast and another one in the evening Primary outcome(s): Diarrhea grade. Timepoint: Weekly from one week before radiotherapy until end of treatment. Method of measurement: Common Toxicity Criteria system.;Stool consistency score. Timepoint: Weekly from one week before radiotherapy until end of treatment. Method of measurement: Bristol scales.;Blood cell counts. Timepoint: Weekly from one week before radiotherapy until end of treatment. Method of measurement: cell counter machine.;Serum IgA level. Timepoint: Weekly from one week before radiotherapy until end of treatment. Method of measurement: Autoanalyzer machine. Study Design: Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.

Project description:Beneficial effects of long-chain omega-3 polyunsaturated fatty acids (n-3 FAs) are generally well-known from epidemiological studies, but the various mechanisms of action are not completely clarified. Regulation of gene expression is one known mechanism of action, but only very limited data of regulated pathways in humans after n-3 FA supplementation are available. Up to now, no studies compared gene expression changes after n-3 FA supplementation between normolipidemic and dyslipidemic subjects. Therefore, the aim of this study was to investigate the effects of n-3 FA administration on whole genome expression profiles in the blood of normo- and dyslipidemic subjects. We conducted an intervention study with normo- and dyslipidemic men aged between 29 and 51 years, which were subdivided into four groups with a balanced age distribution and randomized to either six fish oil capsules per day providing 1.5 g docosahexaenoic acid and 1.0 g eicosapentaenoic acid or corn oil capsules rich in linoleic acid per day for a period of 12 weeks. Venous blood samples were collected at baseline as well as after 4 hours, 1 week and 12 weeks of supplementation. For each investigation time point, the samples of each group were pooled together to minimize inter-individual variability. All subjects have successfully completed the study, but for the microarray experiments, nine subject samples were excluded. Therefore, the microarray experiments are based on the following group characteristics: normolipidemic fish oil group (FO-N): pool of nine RNAs from normolipidemic subjects supplemented with fish oil; normolipidemic corn oil group (CO-N): pool of six RNAs from normolipidemic subjects supplemented with corn oil; dyslipidemic corn oil group (CO-D): pool of eight RNAs from dyslipidemic subjects supplemented with corn oil; dyslipidemic fish oil group (FO-D): pool of nine RNAs from dyslipidemic subjects supplemented with fish oil. The twenty normolipidemic and the twenty dyslipidemic subjects were subdivided into two groups. Thus, a total of four groups with ten men per group passed through the study. To realize a comparable mean age between groups, the formation of groups was performed by stratified allocation according to subject's age. The four study groups were randomly assigned to different study products by an uninvolved collaborator. Subjects ingested either six FO or six corn oil (CO) capsules per day for a period of twelve weeks. The daily n-3 PUFA intake via FO capsules was 2.7 g (1.14 g DHA and 1.56 g EPA). The predominant FA of the CO capsules was the omega-6 (n-6) PUFA linoleic acid (LA, 18:2n-6). Thus, the daily LA intake via CO capsules was 3.05 g LA. The subjects were instructed to ingest the capsules together with food, three in the morning and three in the evening, and to maintain their usual exercise and dietary habits throughout the intervention time. As an exception, at the first intervention day, all six capsules were ingested at the same time in the morning after a standardised breakfast. During each visit, fasting blood samples were collected by venepuncture. Additionally, participants completed a questionnaire to obtain information about changes in medication, dietary (e.g., changes in weekly fish intake, preferred fish dishes or species, respectively) and lifestyle habits (e.g., physical activity), as well as the tolerability of the capsules. This record summarizes the results of 16 microarrays. The samples originate from whole blood of normo- and dyslipidemic subjects supplemented with either fish oil or corn oil for 4 h, 1 week and 12 weeks. Microarrays were hybridized in a loop design with one common reference using a dye-swap approach.

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Evaluating the possible effect of melatonin on oxaliplatin-induced peripheral neuropathy

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