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IRCT20200408046990N5 IRCT 2020-12-17 Mashhad University of Medical Sciences Evaluation of oral formulation of Nano Silymarin efficacy, as an adjuvant to XELOX or FOLFOX regimen treatment for metastatic colorectal cancer Evaluation of oral formulation of Nano Silymarin efficacy, as an adjuvant to XELOX or FOLFOX regimen treatment for metastatic colorectal cancer: A triple blinded, randomized clinical trial 2021-02-19 anticipated 60 Complete https://irct.ir/trial/52522 interventional 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. 2 Metastatic colorectal cancer. 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. Yes - There is a plan to make this available What will be shared: The findings will be published in an article. Study protocol and statistical analysis will be used for article publication. When: One year after the end of the study it will be published and available in databases. To whom: If the funding sponsor allowed, the findings will be available for researchers, clinicians and scientific centers. Conditions: The other researchers can use our findings in their review articles and meta analysis. Where to obtain: For this purpose, you can contact with Sepideh Elyasi at Clinical Pharmacy Department, School of Pharmacy, Vakil Abad Aven, Mashhad, Iran. Email elyasis@mums.ac.ir How to obtain: After receiving the query, dependent on the requested data, the scientific responsible person of the study will responsible to the query in coordinate with the sponsor within 2 weeks. Comments:
public Hedyieh Karbasforooshan
School of Pharmacy, Ferdowsi University Campus, Vakil Abad Blvd.
Mashhad Iran (Islamic Republic of) 9415945344 +98 51 3180 1588 karbasfh971@mums.ac.ir Mashhad University of Medical Sciences scientific Sepideh Elyasi
School of Pharmacy, Ferdowsi University campus, Vakil Abad Blvd., Mashhad
Mashhad Iran (Islamic Republic of) 9415945344 +98 51 3180 1588 elyasis@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with confirmed histological or cytological diagnosis of metastatic colorectal cancer (stage 4) Based on ultrasound results without NRAS and KRAS mutation or no candidate for target therapy(Contraindications or financial incapacity) Under XELOX or FOLFOX regime treatment Patient consent to study Eastern cooperative oncology group (ECOG) 0/ 1 Hemoglobin≥9g/dL، Neutrophil count≥1.5×103/µL, Platelet count≥10×104/µL Creatinine≤1.5 mg/dl, ALT,AST ≤5 ×ULN، total bilirubin≤2×ULN 18 years 70 years Both use of other antioxidant pregnancy or lactation history of allergy to formulation components diagnosed with more than one cancer history of HF history of autoimmune or immunodeficiency (medical or drug induced) other than chemotherapy history of HBV or HCV candidate of curative surgery C78.5 Secondary malignant neoplasm of large intestine and rectum Treatment - Drugs Placebo 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 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 Metastatic extent. Timepoint: Then 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: Then three courses of chemotherapy and the end of six courses. Method of measurement: (RECIST1.1), based on the doctor's clinical examination. Evaluate patient performance. Timepoint: At the end of three and six chemotherapy courses. Method of measurement: EORTC QLQ-C30, based on the doctor's clinical examination. Incidence of chemotherapy side effects including neuropathy, HFS; based on the doctor's clinical examination. Timepoint: At the beginning and end of six courses. Method of measurement: CTCAE v5, based on the doctor's clinical examination. Evaluation of the patient's liver status. Timepoint: At the beginning and end of six courses. Method of measurement: CTCAE v5, based on the doctor's clinical examination and sonography. Mashhad University of Medical Sciences Approved 2020-11-17 Mashhad University of Medical Sciences, Mashhad University of Medical Sciences,Vakil Abad Blvd Mashhad Razavi Khorasan Iran (Islamic Republic of)