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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.

Must not have

Any concurrent malignancy that requires active systemic therapy

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, day 43 and day 113

Awards & highlights

No Placebo-Only Group

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.

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.

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

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently receiving treatment for another cancer.

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I am not pregnant or breastfeeding.

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I haven't taken probiotics, fiber, bile acid sequestrants, weight loss supplements, or appetite suppressants in the last 30 days.

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I do not have any severe illnesses that could interfere with the study.

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I need treatment with strong cancer drugs or targeted therapy.

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I have diabetes (type 1 or 2) and am receiving treatment for it.

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

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Objective Response Rate (ORR)

Progression Free Survival (PFS)

Quality of Life (QOL)