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

NCT ID: NCT06298734Sponsor: Fred Hutchinson Cancer CenterLast updated: 2026-06-17

Summary

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)

Detailed description

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.

Arms & interventions

  • BehavioralExercise Program

    A high-intensity interval training, aerobic exercise program virtually supervised, home-based, and appointment-based program under direct one-on-one supervision by a trained oncology exercise specialist. Sessions will be conducted via the Zoom platform. Participants will be provided with home stationary bike, heart rate monitor, blood pressure monitor. For participants who do not have a smart device, a Wi-Fi enabled tablet will be provided.

  • BehavioralDiet Program

    A virtual dietary consultation program supervised by trained research staff. Appointments will be conducted via the Zoom platform. Participants will receive an education handout at the baseline visit.

Outcome measures

Primary

  • Proportion of Participants Completing the Intervention Sessions

    The primary outcome is feasibility and will be assessed by the proportion of participants completing the intervention sessions with \>70% completion considered feasible.

    Time frame: Post-intervention (Week 10)

Secondary

  • Change in Gut Microbiome Diversity

    Time frame: Baseline (Week 1) and post-intervention (Week 10)

  • Change in Systemic Immune Function

    Time frame: Baseline (Week 1) and post-intervention (Week 10)

  • Change in Cardiopulmonary Fitness

    Time frame: Baseline (Week 1) and post-intervention (Week 10)

  • Change in Short Physical Performance Battery (SPPB)

    Time frame: Baseline (Week 1) and post-intervention (Week 10)

  • Change in Percent Body Fat

    Time frame: Baseline (Week 1) and post-intervention (Week 10)

  • Change in Lean mass

    Time frame: Baseline (Week 1) and post-intervention (Week 10)

  • Change in Hip circumference

    Time frame: Baseline (Week 1) and post-intervention (Week 10)

  • Change in Waist circumference

    Time frame: Baseline (Week 1) and post-intervention (Week 10)

  • Change in Health-Related Quality of life (EORTC-QLQ C30)

    Time frame: Baseline (Week 1) and post-intervention (Week 10)

  • Change in MDASI-Immunotherapy Questionnaire Score

    Time frame: Baseline (Week 1) and post-intervention (Week 10)

  • Change in Anxiety (HADS)

    Time frame: Baseline (Week 1) and post-intervention (Week 10)

  • Change in Depression (HADS)

    Time frame: Baseline (Week 1) and post-intervention (Week 10)

  • Change in Sleep Quality (PSQI)

    Time frame: Baseline (Week 1) and post-intervention (Week 10)

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (2)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Active Not Recruiting

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109

Recruiting
Dong-Woo Kang, PhD · Contact
206-667-5188dkang@fredhutch.org
Dong-Woo Kang, PhD · Principal Investigator