Impact of a Modified Mediterranean Diet on Colorectal Cancer Patients
Official title: 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
Run by Azienda Socio Sanitaria della Brianza · NCT06794931 · Data updated 2026-11-12
This study is testing whether a modified Mediterranean diet can improve gut health and outcomes for colorectal cancer patients receiving chemotherapy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Azienda Socio Sanitaria della Brianza Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Vimercate, MB) |
| Status | Recruiting |
| Started | July 24, 2024 |
| Main results expected | July 23, 2028 |
| Study ends | July 23, 2028 |
| Registry record updated | January 27, 2025 |
| Trial ID | NCT06794931 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with a diagnosis of metastatic colorectal cancer who are undergoing first-line chemotherapy.
✕Probably not a fit
Patients with a MUST score greater than 2 or those requiring parenteral or enteral nutrition may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates how a Modified Mediterranean Diet affects the intestinal microbiota in patients with metastatic colorectal cancer undergoing chemotherapy. Participants will be randomized into two groups: one following the modified diet and the other maintaining their usual diet. The study will assess nutritional status, collect biological samples, and monitor clinical progress over several visits. The goal is to understand the relationship between diet, microbiome diversity, and patient outcomes.
Why it matters
Potential benefit: If successful, this study could improve the quality of life and treatment outcomes for colorectal cancer patients through dietary modifications.
How similar studies have gone: Other studies have shown promising results with dietary interventions in cancer treatment, suggesting potential benefits, though this specific approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
U.O. di Oncologia di Vimercate, ASST-Brianza
Vimercate, Mb, Italy Recruiting
Study contacts
- Study coordinator: Salvatore Artale, MD
- Email: salvatore.artale@asst-brianza.it
- Phone: +390396657115
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.