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Prebiotic Food-enriched Diet (PreFED) for Unresectable Melanoma

This study is exploring if a special diet, called a Prebiotic Food-Enriched Diet (PreFED), can help people with unresectable melanoma (melanoma that cannot be removed by surgery) who are starting immunotherapy. Researchers want to see if this diet changes the good bacteria in your gut, specifically increasing a type called Faecalibacterium. They will also look at how well the immunotherapy works, your quality of life, and any side effects from the diet. You may be able to join if you are at least 18 years old, speak English, and have unresectable melanoma. The study aims to enroll 75 participants, but the current recruitment status is unclear.

Study design
This interventional study plans to enroll 75 participants. It is not specified if it is randomized or blinded.
What's involved
Participants will follow a Prebiotic Food-Enriched Diet (PreFED) given by mouth. Stool samples will be collected at various times, and overall health and diet-related side effects will be monitored.
Compensation
Not stated in the trial record.
Follow-up
The effect of the dietary intervention on Faecalibacterium will be measured for up to 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06466434

Prebiotic Food-enriched Diet (PreFED) to Enhance the Microbiome and Response to First-line Immunotherapy in Unresectable Melanoma

Recruiting
PHASE2Ages 18+InterventionalSupportive care
M.D. Anderson Cancer Center
~75 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:Prebiotic Food-Enriched Diet

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluate the effect of dietary intervention on the abundance of Faecalibacterium in stool samples from baseline.
Measured over Up to 2 years

Conditions

Unresectable Melanoma

Explore related trials

Melanoma

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Erez Baruch, MD,PHD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Erez Baruch, MD,PHD
[email protected],
713-745-5530
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age ≥18 years old
English-speaking
Body mass index (BMI) 18.5-45 kg/m2
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Histologically confirmed stage III/IV, unresectable cutaneous, uveal, acral or mucosal melanoma. Asymptomatic brain metastases are allowed.
Planned initiation of 1st line standard-of-care approved immune checkpoint blockade (anti-PD1 +/- anti-CTLA4 or anti-LAG3 inhibitors or talimogene laherparepvec T-VEC) in the metastatic setting. Prior targeted therapy or ICB in the adjuvant setting is allowed.
Returning to MD Anderson for restaging and follow-up (ICB treatment may occur locally)
Measurable disease per RECIST 1.1 or RANO criteria. Up to 10 patients without measurable can be enrolled.
WOCP must have negative UPT within 1 week of beginning dietary intervention.
Self-reported willingness to eat the provided foods (with some tailoring to their food preferences)
Self-reported willingness to comply with scheduled visits, undergo venipuncture, provide stool samples.

Exclusion

Previous ICB treatment in the metastatic setting
History of inflammatory bowel disease, total colectomy, or bariatric surgery.
Currently taking steroids \> Prednisone 10 mg/day or equivalent
Medical contraindications to the Intervention Diet as determined by the treating physician.
Self-reported major dietary restrictions, including but not limited to relevant food allergies, celiac disease, or diets such as vegan, ketogenic, extended fasting.
Insulin-dependent diabetes or condition requiring bile acid sequestrants
Unable or unwilling to undergo study procedures.
IV antibiotic use in the past month or oral antibiotic use in past 2 weeks.
Regularly taking supplements containing prebiotics, fiber and/or probiotics, and unable/unwilling to discontinue for the purpose of the study.
Current smoker or heavy drinker (defined as \>14 drinks per week) or current illicit drug use.
Currently pregnant, planning to become pregnant, or lactating.
Concurrent malignancy requiring systemic therapy other than hormonal therapy.
Cognitively impaired adults

What this trial measures

  • Evaluate the effect of dietary intervention on the abundance of Faecalibacterium in stool samples from baseline.Up to 2 years