Study on the Impact of a Modified Mediterranean Diet, in Patients With Colorectal Cancer Undergoing Active Medical Oncology Treatment
Recruiting · NCT06794931 · Interventional (participants receive a specific treatment) · Lead sponsor: Azienda Socio Sanitaria della Brianza
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 is running
1 location listed.
- U.O. di Oncologia di Vimercate, ASST-Brianza - Vimercate, MB, Italy