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Evaluation of oral formulation of Nano Silymarin efficacy, as an adjuvant to XELOX or FOLFOX regimen treatment for metastatic colorectal cancer

ABSTRACT: Intervention 1: Intervention group: Nanosiline Marine 70 mg capsule (softgel sinalive 70mg) prepared by Elixir Nanosina Company twice a day (after breakfast and dinner) for 6 21-day courses of XELOX or FOLFOX diet. Intervention 2: Control group: Placebo with the same appearance prepared by Exiranano Sina Company twice a day (after breakfast and dinner) for 6 21-day courses of XELOX or FOLFOX diet. Primary outcome(s): 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: Then three courses of chemotherapy and the end of six courses. Method of measurement: (RECIST1.1), based on the doctor’s clinical examination.;Metastatic extent. Timepoint: Then three courses of chemotherapy and the end of six courses. Method of measurement: Periodic Radiography. Study Design: Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: With the help of a randomization list provided by randomization.com site, patients in the order of inclusion in the study will receive code 1 or 2 and will be included in placebo or medication group, Blinding description: Nano-silymarin and placebo soft gels packages in identical-looking 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. Data collection and analysis will be performed by the clinical pharmacy resident and the clinical pharmacist. All of them will be unaware that A or B is on medication or placebo until the end of the study and data analysis.

DISEASE(S): Metastatic Colorectal Cancer,Secondary Malignant Neoplasm Of Large Intestine And Rectum

PROVIDER: 2501497 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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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

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: 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 1: Treatment sessions based on Unified Transdiagnostic Treatment book of Barlow & et al will be performed according to the protocol (1 session per week, each session about 90 minutes – 8 sessions during 2 months). Measurements will be performed again in three times: the middle of treatment, the end of treatment and once in two months after the end of treatment. Intervention 2: Intervention group 2: Treatment sessions based on Acceptance and Commitment Therapy book of Hayes, Strosahl, & Wilson will be performed according to the protocol (1 session per week, each session about 90 minutes – 8 sessions during 2 months). Measurements will be performed again in three times: the middle of treatment, the end of treatment and once in two months after the end of treatment. Intervention 3: Control group: This group of 15 randomly selected individuals will receive no treatment for two months. However, the control group, which has been bothering to participate in the research, at the end of the study period is freely and intensively subject to one of the treatments of Acceptance and Commitment Therapy or Unified Transdiagnostic Treatment. Primary outcome(s): Psychological distress. Timepoint: The middle of treatment, after treatment and two months after the end of treatment. Method of measurement: Depression Anxiety and Stress Scale.;Meta-emotion beliefs. Timepoint: The middle of treatment, after treatment and two months after the end of treatment. Method of measurement: Meta-Emotions Scale.;Acceptance. Timepoint: The middle of treatment, after treatment and two months after the end of treatment. Method of measurement: Acceptance and Action Questionnaire.;Post-traumatic growth. Timepoint: The middle of treatment, after treatment and two months after the end of treatment. Method of measurement: Post-traumatic Growth Questionnaire. Study Design: Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The block randomization method is performed by the statistical consultant as follows: randomization is performed in three groups: acceptance and commitment therapy, unified transdiagnostic treatment and control. First, a list of eligible individuals is provided and coded. In block randomization, the number of participants in all groups will be very close together by making blocks of sequences so that the same number of participants are assigned to study groups within each group. We first code the groups in Latin letters as follows: A = acceptance and commitment therapy, B = unified transdiagnostic treatment, and C = control group. In this study with three groups A, B and C, we create the following six groups and assign a number from 1 to 6 to each group: ABC-ACB-BAC-BCA-CAB-CBA, Then, using the table of random numbers, we contract that if the n

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

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Evaluation of oral formulation of Nano Silymarin efficacy, as an adjuvant to XELOX or FOLFOX regimen treatment for metastatic colorectal cancer

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