High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFred Hutchinson Cancer Center
About this trial
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
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Exercise Program
- Diet Program
Treatment groups
40 Participants
are divided into 4 treatment groupsSponsors and collaborators
Fred Hutchinson Cancer Center
Lead sponsor
World Cancer Research Fund International
Collaborator
American Association for Cancer Research
Collaborator
Source ClinicalTrials.gov