Could prebiotic snacks boost melanoma treatment?
NCT ID NCT06548789
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding a prebiotic-rich diet to standard immunotherapy before surgery can improve immune response in people with melanoma. About 35 adults with resectable melanoma will receive prebiotic snack packs and diet counseling alongside their usual treatment. The main goal is to see if patients can stick with the diet and how it affects their gut microbiome and treatment outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Prebiotic snack packouts and dietary counseling
- What this could lead to
- If it works, this could show that adding prebiotic foods to standard immunotherapy improves treatment response in melanoma patients.
- What could go wrong
- This is a small, early-phase trial with only 35 participants, so results may not apply to everyone. The diet may be hard to follow, and it's unclear if it will meaningfully improve outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 35 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Sep 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 18 years old. 2. Body mass index (BMI) 18.5-45 kg/m2 3. Able to self-complete study assessments monitoring diet and gastrointestinal symptom burden 4. ECOG performance status of 0 or 1 5. Histologically confirmed resectable stage IIIB-D or oligometastatic Stage IV cutaneous melanoma or locally invasive/advanced mucosal melanoma as determined by multidisciplinary review 6. Planned initiation of standard-of-care neoadjuvant ipilimumab +/- nivolumab or nivolumab +/- relatlimab 7. Measurable disease per RECIST 1.1 8. WOCP must have negative UPT within 1 week of beginning dietary intervention. 9. Self-reported willingness to eat the provided foods (with some tailoring to their food preferences) 10. Self-reported willingness to comply with scheduled visits, undergo venipuncture, provide stool samples. 11. Archival tissue specimen or planned to undergo tumor biopsy as part of standard of care treatment. Exclusion Criteria: 1. Uveal melanoma 2. History of inflammatory bowel disease, total colectomy, or bariatric surgery 3. Currently taking steroids \> prednisone 10 mg/day or equivalent 4. Medical contraindications to the intervention diet as determined by the treating physician 5. Self-reported major dietary restrictions, including but not limited to relevant food allergies, celiac disease, or diets such as vegan, ketogenic, extended fasting 6. Insulin-dependent diabetes or conditions requiring bile-acid sequestrants 7. Unable or unwilling to undergo study procedures 8. Intravenous (IV) antibiotic \>1 dose in the past month or 1 dose IV/oral antibiotic use in past 2 weeks 9. Regularly taking supplements containing prebiotics, fiber and/or probiotics, and unable/unwilling to discontinue for the purpose of the study 10. Current smoker or heavy drinker (defined as \>14 drinks per week) or current illicit drug use 11. Currently pregnant, planning to become pregnant, or lactating 12. Concurrent malignancy requiring systemic therapy other than hormonal therapy 13. Cognitively impaired adults
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New antibody GNR-051 tested for safety in Hard-to-Treat cancers
- Blood test could spot Melanoma's BRAF mutation
- Blood test aims to catch Cancer's return earlier
- Your gut bacteria may hold the key to whether immunotherapy works
- Can a CXCR1/2 blocker boost radiation against cancer that spreads to the brain lining?
- Can a DNA repair gene flaw make melanoma vulnerable to chemotherapy?