Effects of diet and exercise on melanoma treatment and gut health
The Effect of Diet and Exercise on ImmuNotherapy and the Microbiome (EDEN)
This study tests if a high-fiber, plant-based diet and exercise can help adults with untreated melanoma feel better and improve their gut health while they receive immunotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Drugs / interventions | ipilimumab, nivolumab, relatlimab, pembrolizumab, chemotherapy, immunotherapy |
| Locations | 2 sites (Loma Linda, California and 1 other locations) |
| Trial ID | NCT04866810 on ClinicalTrials.gov |
What this trial studies
This study investigates how dietary changes and physical activity can influence the gut microbiome in adults with untreated melanoma undergoing immunotherapy. Participants will be divided into two groups, following specific diet and exercise plans for four months while providing stool samples and completing health surveys. The study aims to determine if a high-fiber, plant-based diet combined with exercise can enhance the effectiveness of immune checkpoint inhibitors by improving gut microbial diversity. Communication will occur through phone or video calls, eliminating the need for in-person visits.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with previously untreated melanoma who are planning to start immunotherapy.
Not a fit: Patients who have received prior systemic therapy for melanoma or those unable to comply with dietary and exercise requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for melanoma patients by enhancing their response to immunotherapy.
How similar studies have performed: Other studies have shown promising results in modulating the microbiome to improve cancer treatment outcomes, suggesting this approach may be viable.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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.
Where this trial is running
Loma Linda, California and 1 other locations
- Loma Linda University — Loma Linda, California, United States (Suspended)
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: James L Gulley, M.D. — National Cancer Institute (NCI)
- Study coordinator: Katherine O Lee-Wisdom, R.N.
- Email: katherine.lee-wisdom@nih.gov
- Phone: (240) 858-3525
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.