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

NCT04866810 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-04-27

No results posted yet for this study

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....

Conditions

Interventions

BEHAVIORAL

Intervention Arm

High fiber, plant based diet + exercise prescription with ACT sessions

BEHAVIORAL

Control

Standard diet and exercise recommendations

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • James L Gulley, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-25
Primary Completion
2026-10-31
Completion
2027-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04866810 on ClinicalTrials.gov