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Diet and Exercise for Melanoma
N/A
Recruiting
Led By James L Gulley, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status <=2 (Karnofsky >60%).
Participants must have histologically or cytologically confirmed melanoma that has not been treated with any systemic therapy in the past 30 days.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 43 and day 113
Awards & highlights
Study Summary
This trial will test whether a plant-based, high-fiber diet and increased exercise can change the gut microbiome in people with melanoma who are about to start immunotherapy treatment.
Who is the study for?
Adults over 18 with untreated melanoma starting immunotherapy can join. They must be able to follow diet and exercise plans, use specific apps, wear a fitness tracker, complete surveys, and provide stool samples. Excluded are those on other trials or treatments, heavy drinkers, drug users, pregnant women, smokers or recent quitters.Check my eligibility
What is being tested?
The EDEN trial is testing how a plant-based diet and regular exercise affect the gut microbiome in melanoma patients receiving immunotherapy. One group will change their lifestyle significantly while the control group won't alter their habits but will receive healthy guidelines.See study design
What are the potential side effects?
Since this trial focuses on dietary changes and increased physical activity rather than medication or invasive procedures, side effects may include typical reactions to new diets or exercise regimens such as digestive discomfort or muscle soreness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can care for myself but may not be able to do active work.
Select...
My melanoma has not been treated with any systemic therapy in the last 30 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, day 43 and day 113
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 43 and day 113
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
feasibility of conducting a decentralized clinical trial involving diet and exercise prescriptions with stool sample collections in patients receiving immunotherapy
Secondary outcome measures
Objective Response Rate (ORR)
Progression Free Survival (PFS)
Quality of Life (QOL)
Trial Design
2Treatment groups
Experimental Treatment
Group I: 2Experimental Treatment1 Intervention
Control- Standard diet and Exercise
Group II: 1Experimental Treatment2 Interventions
Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Control
2011
Completed Phase 4
~15780
Intervention Arm
2017
N/A
~7590
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,662 Previous Clinical Trials
40,925,993 Total Patients Enrolled
557 Trials studying Melanoma
193,109 Patients Enrolled for Melanoma
James L Gulley, M.D.Principal InvestigatorNational Cancer Institute (NCI)
19 Previous Clinical Trials
35,706 Total Patients Enrolled
3 Trials studying Melanoma
25,071 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently using illegal drugs.I can care for myself but may not be able to do active work.I am currently receiving treatment for another cancer.I am not pregnant or breastfeeding.My melanoma has not been treated with any systemic therapy in the last 30 days.I plan to, or have started immunotherapy with specific drugs, within the last 14 days.I haven't taken probiotics, fiber, bile acid sequestrants, weight loss supplements, or appetite suppressants in the last 30 days.I do not have any severe illnesses that could interfere with the study.You have specific diet or exercise restrictions that would make it hard for you to follow the study's recommended diet and exercise plan.I have not taken antibiotics in the last 30 days.I need treatment with strong cancer drugs or targeted therapy.You drink more than 14 alcoholic drinks per week.You are currently smoking or stopped smoking less than 8 weeks ago.I have diabetes (type 1 or 2) and am receiving treatment for it.I am 18 or older and can speak and understand English.You are not taking any experimental medications, except for relatlimab or nivolumab.
Research Study Groups:
This trial has the following groups:- Group 1: 1
- Group 2: 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the upper limit to the amount of participants in this clinical investigation?
"Affirmative. Based on the information found at clinicaltrials.gov, this research is still in need of participants. Initially posted on December 5th 2022, and last updated November 29th 2022, 80 individuals are sought out from a single study centre for enrolment."
Answered by AI
Is there space available for new participants in this research?
"Affirmative. Evidenced on clinicaltrials.gov, this scientific trial is actively recruiting at the moment. It was first made available to public view on December 5th 2022 and has been revised as recently as November 29th 2022. The study requires 80 individuals spread across 1 location to take part in it."
Answered by AI
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