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The effect of L-Lysine on biomarkers involved in colorectal cancer

ABSTRACT: Intervention 1: L-Lisyne powder 1.5g twice per day in combination with drugs of chemical therapy for patients in treatment group. The duration of treatment with L-lysin is 3 month. Intervention 2: In control group : placebo is powder as the same shape and color as L-lysine in combination with chemotherapy drugs ,twice a day foe 3 month.;Treatment - Drugs;Treatment - Drugs;L-Lisyne powder 1.5g twice per day in combination with drugs of chemical therapy for patients in treatment group. The duration of treatment with L-lysin is 3 month.;In control group : placebo is powder as the same shape and color as L-lysine in combination with chemotherapy drugs ,twice a day foe 3 month. Primary outcome(s): ERCC1(Excision repair cross-complementing rodent repair deficiency, complementation group 1). Timepoint: Baseline and 3 monhts following the end of treatment. Method of measurement: ELISA kit.;VEGF(Vascular endothelial growth facto). Timepoint: Baseline and 3 monhts following the end of treatment. Method of measurement: ELISA kit.;DPD(Dihydropyrimidine dehydrogenase deficiency. Timepoint: Baseline and 3 monhts following the end of treatment. Method of measurement: ELISA kit.;TS(Thymidylate synthase). Timepoint: Baseline and 3 monhts following the end of treatment. Method of measurement: ELISA kit.;CEA-Carcino Embryonic Antigen. Timepoint: Baseline and 3 monhts following the end of treatment. Method of measurement: ELISA kit. Study Design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention.

DISEASE(S): Malignant Neoplasm Of Rectum,Condition 1: Colonl Cancer. Condition 2: Rectum Cancer,Malignant Neoplasm Of Colon

PROVIDER: 2480091 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Intervention 1: Stinging nettle tablet, produced in the company of barijessence, 400 mg tablet, three times a day for 3 months in intervention group. Intervention 2: Placebo, tablets containing starch, produced in Tehran University of Medical Sciences, 400 mg tablet, three times a day for 3 months in control group.;Treatment - Drugs;Placebo;Stinging nettle tablet, produced in the company of barijessence, 400 mg tablet, three times a day for 3 months in intervention group;Placebo, tablets containing starch, produced in Tehran University of Medical Sciences, 400 mg tablet, three times a day for 3 months in control group. Primary outcome(s): Erythrocyte Sedimentation Rate. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: Automation Method (mm/h).;High- sensitivity C- reactive protein. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: It is measured by kit (ELISA methods) and the unit is mg/dl.;Quality of life. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: Inflammatory Bowel Disease Questionnaire-Short Form.;White blood cell. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: Flow cytometry Method (cells/ml).;Superoxide dismutase. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: It is measured by kit (ELISA methods) and the unit is ng/ml.;Platelet. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: Flow cytometry Method (cells/µl).;Fecal calprotectin. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: It is measured by kit (ELISA methods) and the unit is µg/g.;Tumor necrosis factor alpha. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: It is measured by kit (ELISA methods) and the unit is ng/ml. Study Design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization is done by stratified blocked randomization. Placebo in the form of a double-blind to the participants in this study given. Researchers and patients are blinded to the treatment and placebo groups.

Project description:Intervention 1: Intervention group: Patients with colorectal cancer, stage 4 which receive chemotherapy and vaccine. The allogene vaccine (including three colon cancer cell lines) will be injected in two periods. The first period consists of three consecutive doses: the first dose will be injected one week after diagnosis /surgery, the following two doses will be injected with a week interval. One week after the third injection, chemotherapy will begin. After the first period, chemotherapy begins and continues for six months. The second period of the vaccine starts one month after chemotherapy and includes three consecutive vaccine doses with a distance of one week. Chemotherapy begins and continues two weeks after the sixth injection. 300 million tumor cells (108 cells from each cancer cell line) with 1 million BCG organisms are injected intradermally in the first and second injections. The third, fourth, fifth, and sixth injections contain 300 million irradiated tumor cells. Intervention 2: Control group: Patients with colorectal cancer, stage 4 which receive Chemotherapy treatment 5 weeks after diagnosis /surgery. Primary outcome(s): Measuring the levels of CA19-9. Timepoint: 6 months after the last vaccination. Method of measurement: via Elisa method.;Measuring the levels of CEA. Timepoint: 6 months after the last vaccination. Method of measurement: via Elisa method.;Measuring the levels of alanine aminotransferase. Timepoint: 6 months after the last vaccination. Method of measurement: via Elisa method.;Measuring the levels of aspartate aminotransferase. Timepoint: 6 months after the last vaccination. Method of measurement: via Elisa method.;Measuring the levels of alkaline phosphatase. Timepoint: 6 months after the last vaccination. Method of measurement: via Elisa method.;Measuring the levels of glutamyl tarnspeptidase. Timepoint: 6 months after the last vaccination. Method of measurement: via Elisa method.;Investigation of tumor formation. Timepoint: 6 months after the last vaccination. Method of measurement: via colonoscopy. Study Design: Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.

Project description:Intervention 1: Intervention group: Nanocurcumin 40 mg capsule formulated by Exir Nanosina Inc. thrice a day (after breakfast, lunch and dinner) for 6 21-day courses of XELOX or FOLFOX regimen. Intervention 2: Control group: Placebo with the same appearance prepared by Exir nano Sina Inc. thrice a day (after breakfast, lunch and dinner) for 6 21-day courses of XELOX or FOLFOX regimen. Primary outcome(s): Metastatic extent. Timepoint: after three courses of chemotherapy and the end of six courses. Method of measurement: Periodic Radiography.;Assess CRP levels. Timepoint: At the beginning and after the end of three and six chemotherapy courses. Method of measurement: Blood test.;Assess CEA and CA19-9 levels. Timepoint: At the end of three courses and six courses of chemotherapy. Method of measurement: Blood test.;Radiographic response of the tumor. Timepoint: after three courses of chemotherapy and the end of six courses. Method of measurement: (RECIST1.1), based on the doctor’s clinical examination. Study Design: Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization using Randomization.com will implemented. This method uses simple randomization models such as head or tail, using a random number table or using computer randomization methods, and for example, each client by dropping coin will include in control or intervention group. This method is very simple to implement. Patients will receive enrollment number 1 or 2, respectively, and enter one of two groups of drugs or placebo, Blinding description: Nano-curcumin and placebo soft gels packages in identical bottle will be delivered to the clinician. Patients who meet the inclusion criteria will be selected by clinician to be included in the study, randomly assigned to a drug or placebo group and be given a bottle with A or B mark. The physician and the resident of clinical pharmacy will evaluate patients in the course of treatment. Dat

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The effect of L-Lysine on biomarkers involved in colorectal cancer

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