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

The study will be divided into:

• Screening visit (V0) and Baseline visit (V1): during a control visit, the patient will be asked to participate in the study. After signing the written informed consent for participation in the MIC-1 study, the patient will be screened for his nutritional status. During the visit, a folder will be used to assess nutritional status. Routine blood tests will be carried out, a serum sample will be taken to measure nutritional markers and lifestyle will be assessed. Furthermore, the detection of anthropometric measurements (weight, height, BMI), bioimpedance analysis, estimation of calorie-protein needs and Malnutrition Universal Screening Tool (MUST) nutritional screening is envisaged. Once the study inclusion criteria are met, the patient will return for a visit and randomization into the study arms will take place. Arm A will then be given the modified Mediterranean diet (DMM), while arm B will continue to follow its usual diet. The patient will deliver the fecal sample. Subsequent patient visits will take place every 15 or 21 days depending on the ongoing therapy.
• Visit V2: this visit will be carried out approximately 45 days after the baseline visit. The patient will deliver the stool sample.
• Visit V3: this visit will be carried out approximately 90 days after the baseline visit. During this visit, as per clinical practice, the radiological re-evaluation will be carried out.

Inclusion criteria

• Eastern Cooperative Oncology Group performance status (ECOG): 0 or 1;
• Age ≥ 18;
• Diagnosis of metastatic colorectal cancer, documented histologically and radiologically according to RECIST 1:1 criteria;
• 1st line chemotherapy treatment +/- biological agent (anti-EGFR, anti-VEGF);
• MUST score 0/1;
• Written informed consent.

Exclusion criteria

• Previous oncological medical therapies;
• Indication for parenteral and/or enteral nutrition;
• MUST score > 2.