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

Phase 2

Recruiting

Conditions: Metastatic colorectal cancer.
Secondary malignant neoplasm of large intestine and rectum
C78.5

Registration Number: IRCT20200408046990N7

Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

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 economic incapability)
XELOX or FOLFOX regimen candidate
Patient consent to study
Eastern cooperative oncology group (ECOG) 0/ 1
Hemoglobin=9g/dL? Neutrophil count=1.5×103/µL, Platelet count=10×104/µLCreatinine=1.5 mg/dl, ALT,AST =5 ×ULN? total bilirubin=2×

Exclusion Criteria

current antioxidant users
pregnancy or lactation
history of hypersensitivity 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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Evaluate patient performance. Timepoint: At the end of three and six chemotherapy courses. Method of measurement: EORTC QLQ-C30 questionnare and 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 criteria and based on the doctor's clinical examination.;Liver function test. Timepoint: At the beginning and end of six courses. Method of measurement: CTCAE v5 criteria and based on the clinicin's clinical examination and sonography.