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High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial

Recruiting

Modulating Immune-Microbiome Axis Through High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* Age ≥18 years.
* Histologically diagnosed with melanoma.
* Having been or newly receiving immunotherapy for at least one month.
* Having a plan to continue immunotherapy for at least 8 weeks at the time of recruitment.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2, indicating the ability to fulfill physical fitness and function assessments.
* Ability to understand and willingness to provide informed consent.

Exclusion Criteria:

* Participating in ≥ 150 minutes of moderate-to-vigorous aerobic exercise per week over the past month.
* Consuming ≥ 30 grams/day of dietary fiber over the past month.
* Having chronic medical conditions that are clinically unstable or uncontrolled with medications, deemed high-risk for exercise. These include but are not limited to unstable cardiac diseases, uncontrolled diabetes, and bone metastases with imminent risk of fracture.
* Having a high risk for noncompliance with study procedures. This will be determined by the study team based on the history of missed oncology appointments (i.e., ≥3 no-shows in 6 months) and poor responsiveness during recruitment (i.e., ≥3 unreturned contacts).
* Patients who are non-English speaking and cannot complete the participant surveys.

About the study

The purpose of this study is to determine whether high-intensity exercise and high-fiber diet are feasible and improve various health outcomes among participants with advanced melanoma receiving immunotherapy.

The names of the groups in this research study are:

* High-Intensity Exercise (EX) * High-fiber Diet (DT) * Combined High-Intensity Exercise and High-Fiber Diet (COMB) * Attention Control (AC)

What is being tested

Sponsor: Fred Hutchinson Cancer Center · Participants: 40 · Started: Jul 1, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06298734

Locations in the U.S.

WashingtonFred Hutch/University of Washington Cancer Consortium, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.