Metastatic colorectal cancer. Secondary malignant neoplasm of large intestine and rectum
Conditions
Interventions
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 o
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 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHedyieh Karbasforooshan
Mashhad University of Medical Sciences
Outcome results
None listed