Metastatic colorectal cancer. Secondary malignant neoplasm of large intestine and rectum
Conditions
Interventions
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. Inter
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
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×ULN
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMahdi Jannati Yazdan Abad
Mashhad University of Medical Sciences
Outcome results
None listed