Study on the Impact of a Modified Mediterranean Diet, in Patients With Colorectal Cancer Undergoing Active Medical Oncology Treatment (MIC-1)

Azienda Socio Sanitaria della Brianza

Status: Enrolling

Conditions: Undefined

Treatments: Other: Biological samples collection; Other: Nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT06794931

MIC-1

Details and patient eligibility

About

The study plans to evaluate the impact of the Modified Mediterranean Diet on the biodiversity of the intestinal microbiota (the set of physiological bacteria present at the intestinal level) in patients suffering from metastatic colorectal cancer undergoing chemotherapy treatment +/- biological agent, comparing the microbiota with that of patients following a Western or standard diet.

Specifically, as well demonstrated in clinical studies, there are populations of bacteria that play a role in protecting the intestinal barrier and whose proliferation could be promoted by the Modified Mediterranean Diet.

The study also intends to evaluate the influence of the microbiome on the clinical progress of the disease in terms of side effects and quality of life.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

modified Mediterranean diet (DMM)

Experimental group

Description:

It consists of a food plan in favor of bacterial biodiversity which focuses above all on foods containing high quality prebiotic fibres, instead reducing the total quantity of fibers compared to the indications provided by the Reference Intake Levels of Nutrients and Energy (LARN) for the Italian population, in consideration of the gastrointestinal side effects of chemotherapy.

Treatment:

Other: Nutrition

Other: Biological samples collection

standard western diet (DSO)

Other group

Description:

The Western Diet or standard diet represents the diet most commonly used by the population in many developed countries; it reflects participants' daily eating habits, ensuring that the control group accurately represents typical eating behavior.

Treatment:

Other: Biological samples collection