Actively Recruiting
High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial
Led by Fred Hutchinson Cancer Center · Updated on 2026-04-01
40
Participants Needed
2
Research Sites
143 weeks
Total Duration
On this page
Sponsors
F
Fred Hutchinson Cancer Center
Lead Sponsor
W
World Cancer Research Fund International
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically diagnosed with melanoma
- Receiving immunotherapy for at least one month
- Planning to continue immunotherapy for at least 8 weeks
- Eastern Cooperative Oncology Group Performance Status of 0-2
- Able to understand and willing to provide informed consent
You will not qualify if you...
- Currently doing 150 minutes or more of moderate-to-vigorous aerobic exercise per week
- Consuming 30 grams or more of dietary fiber daily
- Having unstable or uncontrolled chronic medical conditions that make exercise high-risk, such as unstable cardiac disease, uncontrolled diabetes, or bone metastases with fracture risk
- At high risk for not following study procedures, based on missed oncology appointments or poor responsiveness
- Not able to speak English or unable to complete study surveys
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
D
Dong-Woo Kang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
4
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