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

RecruitingNA

Sponsor: Fred Hutchinson Cancer Center

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

Interventions: Exercise Program, Diet Program

Countries: United States

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)

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (2)

Boston, Massachusetts, United States
Seattle, Washington, United States