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

NCT ID: NCT06794931

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-24
• Study Completion Date: 2028-07-23

Brief Summary

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.

Detailed 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.

Conditions

Undefined

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

modified Mediterranean diet (DMM)

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.

Group Type: EXPERIMENTAL

Nutrition

Intervention Type: OTHER

The patient will be instructed to follow the modified Mediterranean diet or his usual diet based on the assigned treatment group.

Biological samples collection

Intervention Type: OTHER

Additional biological samples will also be collected.

standard western diet (DSO)

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.

Group Type: OTHER

Biological samples collection

Intervention Type: OTHER

Additional biological samples will also be collected.

Interventions

Nutrition

The patient will be instructed to follow the modified Mediterranean diet or his usual diet based on the assigned treatment group.

Intervention Type: OTHER

Biological samples collection

Additional biological samples will also be collected.

Intervention Type: OTHER

Other Intervention Names

Specific diet; Microbiota analyses

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Milano Bicocca

OTHER

Sponsor Role: collaborator

Azienda Socio Sanitaria della Brianza

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

U.O. di Oncologia di Vimercate, ASST-Brianza

Vimercate, MB, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Salvatore Artale, MD

Role: CONTACT

salvatore.artale@asst-brianza.it

+390396657115

Facility Contacts

Salvatore Artale, MD

Role: primary

salvatore.artale@asst-brianza.it

+390396657115

Other Identifiers

MIC-1

Identifier Type: -

Identifier Source: org_study_id