This clinical trial tests whether high-intensity exercise and high-fiber diet are feasible and improve various health outcomes among individuals with melanoma receiving immunotherapy. Growing evidence demonstrates that exercise and diet interventions are closely associated with the gut microbiome. High-intensity exercise has been found feasible and safe in several types of cancer patients and is a superior modality compared to moderate continuous exercise in terms of improving health-related outcomes. Eating a diet high in fiber may be more efficient and provide synergistic effects on regulating gut microbiota, involving the changes of energy metabolism and immune regulation, which may in turn immunotherapy outcomes. High-intensity exercise and high-fiber diet may be feasible and effective in improving the gut microbiome health, immune function, physical fitness, treatment-related side effects, and treatment outcomes in patients with melanoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06298734.
Locations matching your search criteria
United States
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer ConsortiumStatus: Active
Contact: Dong-Woo Kang
Phone: 206-667-5188
PRIMARY OBJECTIVE:
I. To investigate the feasibility of 8-week high-fiber diet and/or exercise in patients with melanoma receiving immunotherapy.
SECONDARY OBJECTIVES:
I. To examine the effects of diet and/or exercise on the gut microbiome diversity in patients with melanoma receiving immunotherapy.
II. To examine the effects of diet and/or exercise on systemic immune function in patients with melanoma receiving immunotherapy.
III. To examine the effects of diet and/or exercise on physical fitness and function in patients with melanoma receiving immunotherapy.
IV. To examine the effects of diet and/or exercise on patient-reported outcomes in patients with melanoma receiving immunotherapy.
EXPLORATORY OBJECTIVE:
I. To explore the preliminary impacts of the high-fiber diet and/or high-intensity exercise interventions on immune-mediated adverse reactions (irAEs)/symptoms and immunotherapy response rate.
OUTLINE: Patients are randomized to 1 of 4 groups.
GROUP A: Patients undergo home-based high-intensity interval training over 60 minutes with a virtual-instructor, 3 times a week for 8 weeks. Patients receive home-based exercise-related equipment that includes home stationary bike, heart rate monitor and blood pressure monitor. Patients also undergo blood and stool sample collection on study.
GROUP B: Patients receive a handout that contains information about high-fiber diet including the benefits of high-fiber diet, fiber contents for common foods, tips to adhere to high-fiber diet, serving sizes, and recommended recipes to achieve high-fiber intake for 8 weeks. Patients also undergo blood and stool sample collection on study.
GROUP C: Patients undergo home-based high-intensity interval training over 60 minutes with a virtual-instructor, 3 times a week for 8 weeks. Patients receive home-based exercise-related equipment that includes home stationary bike, heart rate monitor and blood pressure monitor. Patients also receive a handout that contains information about high-fiber diet including the benefits of high-fiber diet, fiber contents for common foods, tips to adhere to high-fiber diet, serving sizes, and recommended recipes to achieve high-fiber intake for 8 weeks. Patients also undergo blood and stool sample collection on study.
GROUP D: Patients receive a general healthy lifestyle guidebook on study. Patients also undergo blood and stool sample collection on study.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
Principal InvestigatorDong-Woo Kang
