Study on the Impact of a Modified Mediterranean Diet, in Patients With Colorectal Cancer Undergoing Active Medical Oncology Treatment

ConditionUndefined
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAzienda Socio Sanitaria della Brianza

About this trial

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 criteria

Qualifiers

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);

Disqualifiers

Previous oncological medical therapies;

Indication for parenteral and/or enteral nutrition;

MUST score > 2.

Trial design

Treatments tested in this trial

  • Nutrition
  • Biological samples collection

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Azienda Socio Sanitaria della Brianza

Lead sponsor

University of Milano Bicocca

Collaborator