High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial
Trial Parameters
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; due to the rarity of the disease in those \<18 years, this age bracket will not be included. * Histologically diagnosed with advanced melanoma. * Having been or newly receiving immune checkpoint inhibitor, including anti-PD1, antiCTLA4, and/or anti-LAG3 monoclonal antibodies, with palliative intent for at least one month with a plan to continue immunotherapy for at least 8 weeks (i.e., study intervention period) at the time of recruitment. * Not receiving other concurrent tumor-directed systemic treatment (e.g., chemotherapy or targeted therapy). * Medically cleared to participate in high-intensity exercise and high-fiber diet by their treating oncologist. * Not having medical conditions that could exacerbate with exercise, such as bone disease at imminent risk of fracture or uncontrolled cardiopulmonary or metabolic diseases (e.g., uncontrolled hypertension or diabetes). * Currently not meeting the physical activity guideline (i.e., more than 150 m