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

NCT04866810 | Suspended

• 2 other identifiers: 10000251000251-C
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief 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

Melanoma

Keywords

Ipilimumab; Pembrolizumab; relatlimab; nivolumab; Lymphocyte activation gene 3; LAG-3; Garmin; anti PD-1/PD-L1; Acceptance and Commitment Training (ACT)

Outcome Measures

Primary Outcomes (1)

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

  Assessing compliance with study requirements (e.g., logging diet, physical activity per the fitness tracker, completing PROs), assessed per arm; 60% compliance is a success

  43 days

Secondary Outcomes (3)

• Progression Free Survival (PFS)

  through day 113

• Quality of Life (QOL)

  baseline, day 43 and day 113

• Objective Response Rate (ORR)

  through day 113

Study Arms (2)

1

EXPERIMENTAL

Intervention

Behavioral: Intervention Arm

2

OTHER

Control- Standard diet and Exercise

Behavioral: Control

Interventions

Intervention Arm BEHAVIORAL

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

1

Control BEHAVIORAL

Standard diet and exercise recommendations

2

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

Loma Linda University

Loma Linda, California, 92350, United States

Location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• James L Gulley, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: April 30, 2021
• Study Start: July 25, 2023
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04-23

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active
• Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. Genomic data are made available via dbGaP through requests to the data custodians.

Locations

US (2)