Study on the Impact of a Modified Mediterranean Diet, in Patients With Colorectal Cancer Undergoing Active Medical Oncology Treatment
Launched by AZIENDA SOCIO SANITARIA DELLA BRIANZA · Jan 24, 2025
Trial Information
Current as of November 10, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating how a Modified Mediterranean Diet may affect the gut bacteria in patients with metastatic colorectal cancer who are receiving chemotherapy, with or without additional targeted treatments. The goal is to see if this special diet can help the good bacteria in the gut thrive, which might improve the body's ability to cope with cancer treatment and enhance the patients' quality of life. The researchers will compare the gut bacteria of participants following this diet to those on a standard Western diet.
To participate in this study, individuals must be at least 18 years old, have a confirmed diagnosis of metastatic colorectal cancer, and be starting their first round of chemotherapy. They should also be in good health with a performance status score of 0 or 1, meaning they can carry out normal activities. Participants will need to agree to take part in the study by providing written consent. Throughout the trial, they can expect to receive support and monitoring related to their diet and health, helping to better understand the relationship between diet, gut bacteria, and cancer treatment outcomes.
Gender
ALL
Eligibility 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.
About Azienda Socio Sanitaria Della Brianza
Azienda Socio Sanitaria della Brianza (ASST Brianza) is a prominent healthcare organization based in Italy, dedicated to providing comprehensive medical services and advancing health outcomes in the region of Brianza. As a clinical trial sponsor, ASST Brianza plays a pivotal role in the design, implementation, and oversight of clinical studies, focusing on innovative therapies and patient-centered care. With a commitment to research excellence and collaboration, ASST Brianza aims to enhance clinical knowledge and improve treatment options through rigorous scientific inquiry and adherence to ethical standards.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Vimercate, Mb, Italy
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported