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Exercise and Diet Interventions During Immunotherapy in Melanoma Patients

Melanoma (Skin) Clinical Trial

Official title:
Modulating Immune-Microbiome Axis Through High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial

Clinical Trial 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)

Clinical Trial Description

This single-center, four-arm, pilot randomized research study is to test if high-intensity exercise and high-fiber diet are feasible and effective in improving the gut microbiome health, immune function, physical fitness, treatment-related side effects, and treatment outcomes in participants with advanced melanoma receiving immunotherapy. Participants will be randomized into 1 of 4 study groups: Group A Exercise, Group B Diet, Group C Combined, and Group D Attention Control. Randomization means a participant will be placed into an intervention group by chance. The information learned by doing this research may help determine whether participating in such lifestyle interventions are tolerable during immunotherapy and exert health benefits among melanoma participants. The research study procedures include screening for eligibility, study visits, stool samples, blood tests, and questionnaires. Participation in this study is expected to last up to a total of 9 weeks. It is expected about 40 people will take part in this research study. This study is sponsored by the World Cancer Research Fund International. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06298734
Study type Interventional
Source Dana-Farber Cancer Institute
Contact Dong-Woo Kang, PhD
Phone 857-215-2229
Email Dong-Woo_Kang@dfci.harvard.edu
Status Not yet recruiting
Phase N/A
Start date July 2024
Completion date March 31, 2026
View Details
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