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High-Intensity Exercise and High-Fiber Diet for Melanoma Patients on Immunotherapy

This study, called the DUO Trial, is looking at whether high-intensity exercise and a high-fiber diet can help people with advanced melanoma who are receiving immunotherapy. Researchers want to see if these lifestyle changes are practical and if they improve health outcomes. You could join if you are at least 18 years old, have melanoma, and have been or will be on immunotherapy for at least one month, continuing for at least 8 weeks. The study will measure how many participants complete the exercise and diet sessions over 10 weeks to understand if these interventions are feasible. This study is currently unclear on its recruitment status and plans to enroll about 40 people.

Study design
This is a pilot randomized study with four groups: High-Intensity Exercise, High-fiber Diet, a combination of both, and an Attention Control group. About 40 people are expected to participate.
What's involved
You would undergo screening, study visits, provide stool samples, have blood tests, and complete questionnaires. Your participation is expected to last up to 9 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at post-intervention (Week 10), which is when the intervention sessions are completed.

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NCT06298734

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

Recruiting
NAAges 18+InterventionalSupportive care
Fred Hutchinson Cancer Center
~40 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:Exercise ProgramDiet Program

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of Participants Completing the Intervention Sessions
Measured over Post-intervention (Week 10)

Conditions

Melanoma (Skin)
Skin Cancer
Advanced Melanoma

Explore related trials

Melanoma

Where it's being run

2 sites across 2 states
Massachusetts1
Washington1

Study leadership

  • Dong-Woo Kang, PhD · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium

Who to contact

Dong-Woo Kang, PhD
[email protected]
206-667-5188
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Proportion of Participants Completing the Intervention SessionsPost-intervention (Week 10)

    The primary outcome is feasibility and will be assessed by the proportion of participants completing the intervention sessions with \>70% completion considered feasible.