High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial
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
- Exercise Program (behavioral)
- Diet Program (behavioral)
Sponsor: Fred Hutchinson Cancer Center · Participants: 40 · Started: Jul 1, 2024
Contact the study team
- Dong-Woo Kang, PhD · Phone: 206-667-5188
Official record on ClinicalTrials.gov — NCT06298734
Locations in the U.S.
| Washington | Fred 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.