RecruitingPhase 2NCT06466434
Prebiotic Food-enriched Diet (PreFED) to Enhance the Microbiome and Response to First-line Immunotherapy in Unresectable Melanoma
Sponsor
M.D. Anderson Cancer Center
Enrollment
75 participants
Start Date
Sep 1, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
To learn about the possible effects of a prebiotic food-enriched diet (PreFED) targeting the gut microbiome in participants with melanoma who are starting immune checkpoint blockade (ICB) therapy.
Eligibility
Min Age: 18 Years
Plain Language Summary
Simplified for easier understanding
This study is testing whether eating a diet rich in prebiotics (foods that feed beneficial gut bacteria) can improve how well immunotherapy drugs work against advanced melanoma (a serious skin cancer) by boosting the gut microbiome.
**You may be eligible if...**
- You are 18 or older
- You have been diagnosed with advanced stage III or IV melanoma that cannot be surgically removed
- You are about to start first-line immunotherapy (anti-PD1 or similar drug)
- Your BMI is between 18.5 and 45
- You speak English and can return to MD Anderson for follow-up visits
**You may NOT be eligible if...**
- You have previously received immunotherapy in the metastatic setting (prior adjuvant use may be allowed)
- You have symptomatic brain metastases
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
OTHERPrebiotic Food-Enriched Diet
Given by PO
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06466434
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