NCT06298734Recruiting
High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial
Modulating Immune-Microbiome Axis Through High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial
Source: ClinicalTrials.gov · Last updated 19 Aug 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 1 Mar 2024
- Start date
- 1 Jul 2024
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Fred Hutchinson Cancer Center
- Diseases
- Melanoma
- NCT number
- NCT06298734
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 1 Jul 2024 to the primary completion date, 31 Jul 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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).
Other
- 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.
- Patients who are non-English speaking and cannot complete the participant surveys.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Active, not recruiting |
| Fred Hutch/University of Washington Cancer Consortium Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.