RecruitingNot ApplicableNCT06794931

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


Sponsor

Azienda Socio Sanitaria della Brianza

Enrollment

40 participants

Start Date

Jul 24, 2024

Study Type

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether following a modified Mediterranean diet — rich in vegetables, whole grains, healthy fats, and lean proteins — can improve outcomes for people with advanced (metastatic) colorectal cancer who are currently receiving chemotherapy with or without targeted therapy. **You may be eligible if...** - You are 18 or older - You have been diagnosed with metastatic colorectal cancer (confirmed by biopsy and imaging) - You are currently receiving first-line chemotherapy, with or without a biological drug (like bevacizumab or cetuximab) - You are generally in good health and able to carry out daily activities - You have not been previously treated with cancer medications - You are not malnourished (nutritional screen score 0-1) **You may NOT be eligible if...** - You have received prior chemotherapy or other cancer treatments - You require tube feeding or IV nutrition - You have a nutritional risk score greater than 2 (significant malnutrition) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNutrition

The patient will be instructed to follow the modified Mediterranean diet or his usual diet based on the assigned treatment group.

OTHERBiological samples collection

Additional biological samples will also be collected.


Locations(1)

U.O. di Oncologia di Vimercate, ASST-Brianza

Vimercate, MB, Italy

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NCT06794931


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