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

January 24, 2025 updated by: Azienda Socio Sanitaria della Brianza

Randomized Pilot Study on the Impact of a Modified Mediterranean Diet (DMM) on the Intestinal Microbiota and Clinical Outcome in Patients With Colorectal Cancer Undergoing Active Medical Oncology Treatment

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • MB
      • Vimercate, MB, Italy, 20871

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Nutrition
The patient will be instructed to follow the modified Mediterranean diet or his usual diet based on the assigned treatment group.
Other Names:
  • Specific diet
Other: Biological samples collection
Additional biological samples will also be collected.
Other Names:
  • Microbiota analyses
Other: 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.
Other: Biological samples collection
Additional biological samples will also be collected.
Other Names:
  • Microbiota analyses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the impact of the modified Mediterranean diet (DMM, Arm A) compared to a standard Western diet (DSO, Arm B) on microbiota
Time Frame: V2 (45 days after V1)
Comparison of the Firmicutes/Bacteroidetes ratio after 45 days (V2) of first-line chemotherapy +/- biological agent (anti-Epidermal Growth Factor Receptor (EGFR), anti-VEGF) in patients on a modified Mediterranean diet (DMM) compared to patients on a standard Western diet (DSO)
V2 (45 days after V1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the percentage of patients with gastrointestinal effects
Time Frame: V2 (45 days after V1)
Comparison of the percentage of patients with gastrointestinal effects in Arm A versus Arm B.
V2 (45 days after V1)
Comparison of the percentage of patients with severe gastrointestinal effects
Time Frame: V2 (45 days after V1)
Comparison of the percentage of patients with severe gastrointestinal effects (G3/G4) in Arm A versus Arm B.
V2 (45 days after V1)
Variation of the change in the Firmicutes/Bacteroidetes ratio
Time Frame: Baseline (V1), after 45 day from baseline (V2), after 90 days from baseline (V3)
Evaluation of the change in the Firmicutes/Bacteroidetes ratio over 3 time points
Baseline (V1), after 45 day from baseline (V2), after 90 days from baseline (V3)
Variation of the overall composition of the microbiome
Time Frame: Baseline (V1), after 45 day from baseline (V2), after 90 days from baseline (V3)
Evaluation of the overall composition of the microbiome over 3 time points
Baseline (V1), after 45 day from baseline (V2), after 90 days from baseline (V3)
Variation of the microbiome and metabolome
Time Frame: Baseline (V1), after 45 day from baseline (V2), after 90 days from baseline (V3)
Evaluation of the microbiome and metabolome over 3 time points
Baseline (V1), after 45 day from baseline (V2), after 90 days from baseline (V3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Socio Sanitaria della Brianza

Collaborators

University of Milano Bicocca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2024

Primary Completion (Estimated)

July 23, 2028

Study Completion (Estimated)

July 23, 2028

Study Registration Dates

First Submitted

January 21, 2025

First Submitted That Met QC Criteria

January 24, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 24, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIC-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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