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

Modulating Immune-Microbiome Axis Through High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial

This study is testing whether high-intensity exercise and a high-fiber diet can help improve health for melanoma patients receiving immunotherapy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fred Hutchinson Cancer Center (other)
• Drugs / interventions: immunotherapy
• Locations: 2 sites (Boston, Massachusetts and 1 other locations)
• Trial ID: NCT06298734 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically diagnosed advanced melanoma who are receiving immunotherapy.

Not a fit: Patients currently undergoing other tumor-directed systemic treatments or those with medical conditions that contraindicate exercise may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance treatment outcomes and quality of life for melanoma patients receiving immunotherapy.

How similar studies have performed: While similar lifestyle interventions have shown promise in other cancer types, this specific approach in advanced melanoma is relatively novel.

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.

Where this trial is running

Boston, Massachusetts and 1 other locations

• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (RECRUITING)
• Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States (RECRUITING)

Study contacts

• Principal investigator: Dong-Woo Kang, PhD — Fred Hutch/University of Washington Cancer Consortium
• Study coordinator: Dong-Woo Kang, PhD

Conditions: Melanoma, Skin Cancer, Advanced Melanoma