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)

MD Anderson Cancer Center

Houston, Texas, United States

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NCT06466434


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