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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 below
Select...
I can care for myself but may not be able to do active work.
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My melanoma has not been treated with any systemic therapy in the last 30 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 43 and day 113
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 43 and day 113 for reporting.

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
13,728 Previous Clinical Trials
40,965,923 Total Patients Enrolled
559 Trials studying Melanoma
195,362 Patients Enrolled for Melanoma
James L Gulley, M.D.Principal InvestigatorNational Cancer Institute (NCI)
19 Previous Clinical Trials
35,710 Total Patients Enrolled
3 Trials studying Melanoma
25,071 Patients Enrolled for Melanoma

Media Library

Control Clinical Trial Eligibility Overview. Trial Name: NCT04866810 — N/A
Melanoma Research Study Groups: 1, 2
Melanoma Clinical Trial 2023: Control Highlights & Side Effects. Trial Name: NCT04866810 — N/A
Control 2023 Treatment Timeline for Medical Study. Trial Name: NCT04866810 — N/A
~21 spots leftby Oct 2024
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