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

NCT06298734 · Fred Hutchinson Cancer Center
In plain English

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Official title
Modulating Immune-Microbiome Axis Through High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial
About this study
This single-center, four-arm, pilot randomized research study is to test if high-intensity exercise and high-fiber diet are feasible and effective in improving the gut microbiome health, immune function, physical fitness, treatment-related side effects, and treatment outcomes in participants with advanced melanoma receiving immunotherapy. Participants will be randomized into 1 of 4 study groups: Group A Exercise, Group B Diet, Group C Combined, and Group D Attention Control. Randomization means a participant will be placed into an intervention group by chance. The information learned by doing this research may help determine whether participating in such lifestyle interventions are tolerable during immunotherapy and exert health benefits among melanoma participants. The research study procedures include screening for eligibility, study visits, stool samples, blood tests, and questionnaires. Participation in this study is expected to last up to a total of 9 weeks. It is expected about 40 people will take part in this research study. This study is sponsored by the World Cancer Research Fund International and American Association for Cancer Research.
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.
Study design
Enrollment target: 40 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-07-01
Estimated completion: 2027-03-31
Last updated: 2026-04-01
Interventions
Behavioral: Exercise ProgramBehavioral: Diet Program
Primary outcomes
  • Proportion of Participants Completing the Intervention Sessions (Post-intervention (Week 10))
Sponsor
Fred Hutchinson Cancer Center · other
With: World Cancer Research Fund International, American Association for Cancer Research
Contacts & investigators
ContactDong-Woo Kang, PhD · contact · dkang@fredhutch.org · 206-667-5188
InvestigatorDong-Woo Kang, PhD · principal_investigator, Fred Hutch/University of Washington Cancer Consortium
All locations (2)
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Fred Hutch/University of Washington Cancer ConsortiumRecruiting
Seattle, Washington, United States