Evaluation of oral nano-formulation of Curcumin efficacy, as an adjuvant to XELOX or FOLFOX regimen treatment for metastatic colorectal cancer: A triple blinded, randomized clinical trial
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ABSTRACT: 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
DISEASE(S): Metastatic Colorectal Cancer,Secondary Malignant Neoplasm Of Large Intestine And Rectum
PROVIDER: 2501499 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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