SUSPENDED

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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....

Official Title

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

Quick Facts

Study Start:2023-07-25

Study Completion:2027-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:SUSPENDED

Study ID

NCT04866810

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 120 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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 * 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.

Inclusion Criteria

Exclusion 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.

* 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
* 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.

Contacts and Locations

Principal Investigator

James L Gulley, M.D.

PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Study Locations (Sites)

Loma Linda University

Loma Linda, California, 92350

United States

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-25

Study Completion Date2027-03-31

Study Record Updates

Study Start Date2023-07-25

Study Completion Date2027-03-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Melanoma