The Effect of Diet and Exercise on ImmuNotherapy and the Microbiome (EDEN)

Paused · Not applicable

Conditions studied: Melanoma

In brief

Background: The gut microbiome is made up microorganisms. These include the good and bad bacteria that live in the digestive tract. Changes in the gut microbiome have been linked to the development of cancer. Researchers want to learn more about the effects of modulating the microbiome with diet and exercise. Objective: To see if nutritional intake and physical activity change the gut microbiome in people with melanoma. Eligibility: Adults age 18 and older with previously untreated melanoma who will be getting immunotherapy treatment for their disease. Design: Participants will not have visits at NIH. They will have phone calls or videocalls. Participants will be screened with a medical history and medical record review. Participants will give stool samples. They will fill out surveys about their health, feelings, diet, and exercise. Participants will be put in 1 of 2 groups. They will follow their group s plan for 4 months. They will be contacted throughout the study. Intervention Group participants will follow a plant-based, high-fiber diet. They will do at least 150 minutes of moderate or 75 minutes of high-intensity exercise per week. They will have sessions with psychology staff to help them make positive lifestyle changes. Control Group participants will be taught healthy eating and exercise guidelines. But they will not be asked to change their diet or exercise habits. All participants will record what they eat in the MyFitnessPal app. They will get a scale to measure their weight each week. They will wear a Garmin(R) physical activity tracker at all times. They can take the tracker off to bathe or shower. Participation will last for 6 months....

Key facts

Study ID

NCT04866810

Run by

National Cancer Institute (NCI)

People needed

24

Starts

2023-07-25

Expected to finish

2027-10-31

Last updated by the study team

2026-04-27

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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 it is running

• Loma Linda University — Loma Linda, California, United States
• National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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