Dataset Information

Investigating the effect of glutamine in colorectal surgery

ABSTRACT: Intervention 1: Intervention group: They will receive glutamine powder (Karen Company) in the form of 30 grams per day for 10 days before surgery. Intervention 2: Control group: They will receive placebo with starch content (Karen Company) for 10 days before surgery. Primary outcome(s): Carcinoembryonic antigen. Timepoint: At the beginning of the study (10 days before surgery), and one month after surgery. Method of measurement: Quantitative electroluminescence. Study Design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this experiment, the balanced random block method will be used, with a block size of 4 (combination of A and B as groups). Using the Randomization.com website, random allocation will be done for 200 people in the form of 50 blocks of 4. Since body mass index is an important variable in the intervention effect. This intervention will be implemented in a classified manner. In order to carry out this trial correctly, a random allocation list will be produced separately for each of the two classes of body mass index 18.5 to 25 and 25 to 30, Blinding description: One of the nurses will be responsible for randomly selecting patients and prescribing supplements for them. In order to carry out this research blindly, the supplements will be completely similar and closed in terms of appearance. Also, glutamine supplement and placebo are separated

DISEASE(S): Malignant Neoplasm Of Colon, Unspecified,Colorectal Cancer

PROVIDER: 94053 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

ACCESS DATA

Similar Datasets

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:Background: We tested the hypothesis that short-term supplementation with a physiological dose of folate can alter global gene expression in the colon of subjects with colorectal adenoma using a randomised double blind placebo controlled trial design. Materials and Methods: Fourteen subjects with histologically confirmed colorectal adenoma, randomised to receive folic acid (400M-BM-5g/d, n=6) or placebo (n=8) for 10 weeks, had blood samples and colonic tissue biopsies collected before and after the intervention. Blood samples were used to determine serum and red cell folate, plasma homocysteine, and genetic polymorphisms in methylenetetrahydrofolate reductase (MTHFR C677T) and methionine synthase (MS A2756G). RNA extracted from normal-appearing colonic tissue samples was used to determine global gene expression in the colon using AffymetrixM-oM-^CM-^R Microarray GeneChips. Microarray results were confirmed by quantitative real time RT-PCR. Two methods were used to analyse the microarray data: (1) differences between pre- and post-intervention gene expression values in the folic acid and placebo groups separately using paired-sample t tests; (2) differences between the folic acid and placebo groups in the ratio of post-intervention to pre-intervention gene expression values using independent sample t-tests. Results: (1) Following intervention, sixty seven genes were up-regulated and 13 genes were down-regulated in the folic acid group, while 21 genes were up-regulated and none were down-regulated in the placebo group (P<0.05, adjusted for multiple testing). (2) Thirty six genes were up-regulated and 18 genes were down-regulated in the folic acid group when compared with placebo, but none of these were statistically significant after adjustment for multiple testing. These genes are involved in multiple pathways, including cell cycle, signal transduction, cell differentiation, transport, cell division, cell motility, protein transport and immune response. There were no genes involved in 1-carbon metabolism that were altered in expression, although several genes involved in neoplasia were up-regulated. Conclusions: These results indicate that while folic acid can modify gene expression, it is difficult to separate its effects from the natural variability in gene expression in the colon. Fourteen patients with colorectal adenoma were treated with either folate supplementation (6 subjects) or a placebo (8 subjects) for 10 weeks in a randomised double-blind trial. Colonic biopsies of normal tissue were taken before and after the intervention, and analysed for gene expression.

Project description: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.

Dataset Information

Investigating the effect of glutamine in colorectal surgery

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets