Lifestyle changes may boost gut health in melanoma fight
NCT ID NCT04866810
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 3 times
Summary
This study looks at whether a high-fiber, plant-based diet and regular exercise can change the gut microbiome in people with melanoma who are receiving immunotherapy. Researchers want to see if these lifestyle changes are feasible and if they might affect how well the treatment works. The study involves 24 adults and is conducted remotely via phone or video calls.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- High-fiber, plant-based diet and exercise prescription
- What this could lead to
- If successful, this could show that lifestyle changes can influence the gut microbiome and possibly improve outcomes for melanoma patients on immunotherapy.
- What could go wrong
- This is a small, early feasibility study (24 participants) that is currently suspended. It is designed to test whether the study procedures work, not to prove any health benefits.
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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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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24 people
The number who actually took part.
- Started
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Jul 2023
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
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 to 120 years
- 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: * Participants must have histologically or cytologically confirmed melanoma that has not been treated with any systemic therapy in the past 30 days. * Participants must be planning to undergo immunotherapy treatment with one of the following options: ipilimumab and nivolumab, relatlimab and nivolumab, pembrolizumab, or nivolumab. Note: This treatment is permissible to have started up to 14 days prior to completion of baseline assessments on this study to still be eligible for enrollment. * Age \>= 18 years and English speaking. English-language ability is required because a portion of the study involves reading and responding to English-language questionnaires, along with creating a free response spoken answer to a question, where the information will be transcribed and analyzed. * Willingness and capability to comply with diet and exercise prescriptions, use the MyFitnessPal app, wear the Garmin (trademark) device, complete surveys, and provide stool samples. Participants must own a smartphone capable of running the MyFitnessPal and Garmin Connect (trademark) apps. * ECOG performance status \<=2 (Karnofsky \>60 percent). * The ability of the subject to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: * Participants who are receiving any investigational agents. * Any concurrent malignancy that requires active systemic therapy * Any health condition that requires treatment with cytotoxic chemotherapy or targeted therapy * Medical contraindications to the study diet and/or exercise prescriptions as determined by a physician * Self-reported dietary and/or exercise restrictions that would preclude adherence to the study diet and exercise prescriptions * Systemic antibiotic use within the past 30 days * Use of probiotic supplements (probiotic foods such as yogurt, kefir, sauerkraut, etc., are permissible), fiber supplements, bile acid sequestrants, weight loss supplements, or appetite suppressants within the last 30 days. * Women known to be pregnant or lactating are excluded from the study because it is unknown if the study diet and exercise prescriptions may have deleterious effects on the child and/or mother in the context of pregnancy/breastfeeding. * Current smoker or \< 8 weeks since smoking cessation. There is evidence that smoking may alter the microbiome. * Heavy drinker defined as \>14 alcoholic drinks per week * Current illicit drug use. There is evidence that illicit drug use may alter the microbiome. * Diagnosis of diabetes mellitus type I or II that requires treatment * Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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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
2 sites. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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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Loma Linda University
Loma Linda, California, 92350, United States
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, 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
- Can a CXCR1/2 blocker boost radiation against cancer that spreads to the brain lining?
- Can a new antibody help the immune system fight Hard-to-Treat tumors?
- Can tumor DNA and immune cells reveal why some cancers resist immunotherapy?
- Can a Two-Drug immune combo shrink melanoma tumors?