NCT06794931Recruiting
Study on the Impact of a Modified Mediterranean Diet, in Patients With Colorectal Cancer Undergoing Active Medical Oncology Treatment
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
Source: ClinicalTrials.gov · Last updated 27 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 21 Jan 2025
- Start date
- 24 Jul 2024
- Primary completion date
- 23 Jul 2028
- Lead sponsor
- Azienda Socio Sanitaria della Brianza
- Diseases
- Colorectal cancer
- NCT number
- NCT06794931
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 24 Jul 2024 to the primary completion date, 23 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous oncological medical therapies;
Other
- Indication for parenteral and/or enteral nutrition;
- MUST score \> 2.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| U.O. di Oncologia di Vimercate, ASST-Brianza Coordinator of this site? Confirm its status | Vimercate | Italy | Recruiting |
Related publications
- The Effects of a Modified Mediterranean Diet on Gut Microbiota and Chemotherapy Side Effects in Patients With Metastatic Colorectal Cancer Undergoing First-Line Chemotherapy With or Without Either Antiepidermal Growth Factor Receptor or Antivascular Endothelial Growth Factor Agent: Protocol for a Randomized Pilot Study in Italy.JMIR Res Protoc · 2025 · PMID 41236788
This page is information, not medical advice. Discuss any trial with your doctor.