Status:
SUSPENDED
The Effect of Diet and Exercise on ImmuNotherapy and the Microbiome (EDEN)
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Melanoma
Eligibility:
All Genders
18-120 years
Phase:
NA
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 o...
Detailed Description
Background: The human gut microbiome is a topic of growing research interest because it modulates many systems, including immune function; and, alterations of the microbiome have been associated with...
Eligibility Criteria
Inclusion
- 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 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.
Exclusion
Key Trial Info
Start Date :
July 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2027
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04866810
Start Date
July 25 2023
End Date
March 31 2027
Last Update
October 24 2025
Active Locations (2)
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1
Loma Linda University
Loma Linda, California, United States, 92350
2
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892