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
Azienda Socio Sanitaria della Brianza
40 participants
Jul 24, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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;
- st line chemotherapy treatment +/- biological agent (anti-EGFR, anti-VEGF);
- MUST score 0/1;
- Written informed consent.
Exclusion Criteria3
- Previous oncological medical therapies;
- Indication for parenteral and/or enteral nutrition;
- MUST score \> 2.
Interventions
The patient will be instructed to follow the modified Mediterranean diet or his usual diet based on the assigned treatment group.
Additional biological samples will also be collected.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06794931