SuspendedNot Applicable

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

Stopped: On hold pending planned interim analysis.

United States24 participantsStarted 2023-07-25

Plain-language summary

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....

Who can participate

Age range18 Years – 120 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 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 tar…

What they're measuring

feasibility of conducting a decentralized clinical trial involving diet and exercise prescriptions with stool sample collections in patients receiving immunotherapy

Timeframe: 43 days

Trial details

NCT IDNCT04866810

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2026-10-31