Study of a Modified Mediterranean Diet's Impact on Gut Bacteria and Clinical Outcomes in Patients with Metastatic Colorectal Cancer Receiving Chemotherapy

What this Trial Is About

Researchers are investigating how a Modified Mediterranean Diet affects the variety of bacteria in the intestines of patients with metastatic colorectal cancer who are receiving chemotherapy with or without biological agents. The study compares this diet's impact on gut microbiota to that of patients following a standard Western diet. It aims to explore how certain bacterial populations that support the intestinal barrier may be promoted by the Modified Mediterranean Diet and to assess how the microbiome influences disease progression, side effects, and quality of life. The study includes a screening visit and baseline visit where nutritional status is assessed through exams, blood tests, and questionnaires. Patients meeting criteria are randomly assigned to either follow the Modified Mediterranean Diet (Arm A) or continue their usual diet (Arm B). Biological samples including stool are collected at baseline and about 45 days later. Follow-up visits occur every 15 to 21 days depending on treatment, with a radiological assessment about 90 days after baseline. Participants will have their nutritional status, lifestyle, and microbiota evaluated through various measurements including bioimpedance and fecal samples. Researchers will monitor the impact of diet on intestinal bacteria at 45 days and review clinical progress and side effects. The study tracks outcomes related to microbiota changes and overall clinical condition during the treatment period.

Study on the Impact of a Modified Mediterranean Diet, in Patients With Colorectal Cancer Undergoing Active Medical Oncology Treatment