Actively Recruiting
Study on the Impact of a Modified Mediterranean Diet, in Patients With Colorectal Cancer Undergoing Active Medical Oncology Treatment
Led by Azienda Socio Sanitaria della Brianza · Updated on 2025-01-27
40
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
A
Azienda Socio Sanitaria della Brianza
Lead Sponsor
U
University of Milano Bicocca
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Study on the Impact of a Modified Mediterranean Diet, in Patients With Colorectal Cancer Undergoing Active Medical Oncology Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group performance status (ECOG) of 0 or 1
- Age 18 years or older
- Diagnosis of metastatic colorectal cancer confirmed by histology and imaging using RECIST 1:1 criteria
- Receiving first-line chemotherapy treatment with or without biological agents (anti-EGFR, anti-VEGF)
- Malnutrition Universal Screening Tool (MUST) score of 0 or 1
- Signed written informed consent to participate
You will not qualify if you...
- Previous oncological medical therapies
- Need for parenteral or enteral nutrition
- Malnutrition Universal Screening Tool (MUST) score greater than 2
AI-Screening
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Trial Site Locations
Total: 1 location
1
U.O. di Oncologia di Vimercate, ASST-Brianza
Vimercate, MB, Italy, 20871
Actively Recruiting
Research Team
S
Salvatore Artale, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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