RecruitingNot ApplicableNCT06298734

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


Sponsor

Fred Hutchinson Cancer Center

Enrollment

40 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

The DUO Trial tests whether a combination of high-intensity exercise and a high-fiber diet can improve how well immunotherapy works in people with advanced melanoma (skin cancer) who are receiving immune checkpoint inhibitor drugs. **You may be eligible if...** - You are 18 or older with advanced melanoma confirmed by tissue testing - You have been receiving or are newly starting immunotherapy (anti-PD1, anti-CTLA4, or anti-LAG3) for at least one month, with plans to continue for at least 8 more weeks - You are not doing enough exercise (less than 150 minutes per week) and not eating enough fiber (less than 30g per day) - Your oncologist has cleared you for high-intensity exercise and a high-fiber diet - You can read and write in English and travel to the study center **You may NOT be eligible if...** - You are receiving other cancer treatments such as chemotherapy or targeted therapy at the same time - You have bone disease at risk of fracture or uncontrolled heart, lung, or metabolic conditions - You are already exercising intensively or already meeting fiber intake guidelines Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALExercise Program

A high-intensity interval training, aerobic exercise program virtually supervised, home-based, and appointment-based program under direct one-on-one supervision by a trained oncology exercise specialist. Sessions will be conducted via the Zoom platform. Participants will be provided with home stationary bike, heart rate monitor, blood pressure monitor. For participants who do not have a smart device, a Wi-Fi enabled tablet will be provided.

BEHAVIORALDiet Program

A virtual dietary consultation program supervised by trained research staff. Appointments will be conducted via the Zoom platform. Participants will receive an education handout at the baseline visit.


Locations(2)

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06298734


Related Trials