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

Recruiting now · Not applicable

Conditions studied: Melanoma (Skin), Skin Cancer, Advanced Melanoma

In brief

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)

Key facts

Study ID

NCT06298734

Run by

Fred Hutchinson Cancer Center

People needed

40

Starts

2024-07-01

Expected to finish

2027-03-31

Last updated by the study team

2026-06-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States (enrolling)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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