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Exercise to Improve Chemotherapy Outcomes and Survival in Metastatic Colorectal Cancer Patients Comparing Aerobic and Muscle Strength Training Effects on Treatment and Immune Function
Led by Radboud University Medical Center · Updated on 2023-11-18
228
Participants Needed
13
Research Sites
39 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating how exercise might affect treatment outcomes for patients with metastatic colorectal cancer receiving chemotherapy. The study focuses on whether exercise can prevent changes to chemotherapy doses caused by toxicity, improve immune function, and enhance progression-free survival. It also seeks to identify the best type and amount of exercise for these benefits. This is a randomized, multi-arm trial using a Bayesian adaptive design to efficiently compare different exercise programs while minimizing patient exposure to less effective options. Participants are randomly assigned to one of three groups a resistance and continuous aerobic exercise group, an aerobic interval and continuous aerobic exercise group, or a usual care group. Those in the exercise groups engage in supervised moderate-to-high intensity sessions twice a week, plus a third session at home. The exercise includes activities like walking, cycling, and resistance exercises targeting large muscle groups. The usual care group receives standard treatment with exercise guidelines provided. The study uses several interim analyses to potentially stop less effective exercise arms early. During the study, participants undergo regular assessments including chemotherapy dose modifications, progression-free survival, immune cell function, hospitalization, treatment-related toxicities, fitness, muscle strength and mass, quality of life, fatigue, resilience, empowerment, and physical activity levels. These measures are taken from baseline through multiple chemotherapy cycles over several months, with outcomes monitored for up to two years. The study aims to better understand how exercise affects treatment effectiveness and patient well-being in metastatic colorectal cancer.
CONDITIONS
Brief Title
Aerobic Fitness or Muscle Mass Training to Improve Colorectal Cancer Outcome
Research Team
L
Laurien M Buffart, PhD
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