NCT06298734 High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial
| NCT ID | NCT06298734 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fred Hutchinson Cancer Center |
| Condition | Melanoma (Skin) |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-07-01 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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)
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.
Contact & Investigator
Dong-Woo Kang, PhD
PRINCIPAL INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Frequently Asked Questions
Who can join the NCT06298734 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Melanoma (Skin). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06298734 currently recruiting?
Yes, NCT06298734 is actively recruiting participants. Contact the research team at dkang@fredhutch.org for enrollment information.
Where is the NCT06298734 trial being conducted?
This trial is being conducted at Boston, United States, Seattle, United States.
Who is sponsoring the NCT06298734 clinical trial?
NCT06298734 is sponsored by Fred Hutchinson Cancer Center. The principal investigator is Dong-Woo Kang, PhD at Fred Hutch/University of Washington Cancer Consortium. The trial plans to enroll 40 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.