High-intensity exercise and high-fiber diet for melanoma patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot randomized study investigates the feasibility and effectiveness of high-intensity exercise and a high-fiber diet in improving health outcomes for patients with advanced melanoma undergoing immunotherapy. Participants will be randomly assigned to one of four groups: exercise, diet, combined exercise and diet, or an attention control group. The study aims to assess the impact of these lifestyle interventions on gut microbiome health, immune function, physical fitness, and treatment-related side effects over a period of 9 weeks. Approximately 40 participants will be involved, with various assessments including stool samples, blood tests, and questionnaires.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fred Hutch/University of Washington Cancer Consortium
  Seattle, Washington, United States Recruiting
• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Active not recruiting

Study contacts

• Principal investigator: Dong-Woo Kang, PhD — Fred Hutch/University of Washington Cancer Consortium
• Study coordinator: Dong-Woo Kang, PhD
• Email: dkang@fredhutch.org
• Phone: 206-667-5188

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.