Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Melanoma | Melanoma | CURATED_BROADER | 0.78 |
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
| Skin Cancer | Malignant Skin Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diet Program | Behavioral | — | UNRESOLVED |
| Exercise Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Group A: High-Intensity Exercise (EX)
- description
- 10 participants will complete: * In-office baseline visit. * Virtual exercise sessions 3x weekly. * Post-intervention in-office visit.
- interventionNames
- Behavioral: Exercise Program
- type
- EXPERIMENTAL
- label
- Group B: High-Fiber Diet (DT)
- description
- 10 participants will complete: * In-office baseline visit. * 1x weekly appointment with research staff to review to review diet adherence. * Post-intervention in-office visit.
- interventionNames
- Behavioral: Diet Program
- type
- EXPERIMENTAL
- label
- Group C: Combined High-Intensity Exercise and High-fiber Diet (COMB)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available