Impact of a Modified Mediterranean Diet on Colorectal Cancer Patients
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
This study is testing whether a modified Mediterranean diet can improve gut health and outcomes for colorectal cancer patients receiving chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Azienda Socio Sanitaria della Brianza Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Vimercate, MB) |
| Trial ID | NCT06794931 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of metastatic colorectal cancer who are undergoing first-line chemotherapy.
Not a fit: Patients with a MUST score greater than 2 or those requiring parenteral or enteral nutrition may not benefit from this study.
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 performed: Other studies have shown promising results with dietary interventions in cancer treatment, suggesting potential benefits, though this specific approach is relatively novel.
Eligibility criteria
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 this trial is running
Vimercate, MB
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.