The Effect of Diet and Exercise on ImmuNotherapy and the Microbiome (EDEN) (NCT04866810) | Clinical Trial Compass
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 range
18 Years – 120 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
feasibility of conducting a decentralized clinical trial involving diet and exercise prescriptions with stool sample collections in patients receiving immunotherapy