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Search / Trial NCT04754672

Aerobic Fitness or Muscle Mass Training to Improve Colorectal Cancer Outcome

Launched by RADBOUD UNIVERSITY MEDICAL CENTER · Feb 11, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Exercise Muscle Strength Cardiorespiratory Fitness Colorectal Cancer Chemotherapy Dose Modification Progression Free Survival Bayesian Adaptive Trial

ClinConnect Summary

This clinical trial is studying how different types of exercise can help people with metastatic colorectal cancer who are receiving palliative chemotherapy. The researchers want to find out if aerobic exercise (like running or cycling) or resistance training (like weight lifting) can reduce the side effects of chemotherapy and help patients maintain their treatment without needing to lower their medication doses. They believe that exercise might not only improve patients' physical well-being but also support their immune system, which is crucial for fighting cancer.

To be eligible for this trial, participants need to be adults aged 65 to 74 with metastatic colorectal cancer who are about to start their first round of chemotherapy. They should be able to walk or bike and agree to participate. Those who have serious health issues that prevent them from exercising safely, or have cognitive disorders, won't be able to join. Participants in the trial can expect to be assigned to one of three groups where they will either do aerobic exercise, resistance training, or receive usual care without exercise. This innovative design allows the researchers to quickly determine which type of exercise is most beneficial, ensuring that participants are not exposed to less effective options for too long. Overall, the goal is to improve the quality of life and treatment outcomes for patients battling colorectal cancer.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • mCRC with indication for palliative chemotherapy
  • scheduled for treatment with first-line doublet or triplet chemotherapy, according to the national guideline
  • able and willing to give written informed consent.
  • Exclusion Criteria:
  • life expectancy \<6 months
  • unable to perform basic activities of daily living such as walking or biking
  • presence of cognitive disorders or severe emotional instability (e.g., Schizophrenia, Alzheimer, alcohol addiction);
  • presence of other disabling co-morbidities that might hamper physical exercise (e.g. heart failure (NYHA classes 3 and 4), chronic obstructive pulmonary disease (COPD, gold 3 and 4), orthopaedic conditions and neurological disorders (e.g., hernia, paresis, amputation, active rheumatoid arthritis);
  • insufficient mastery of the Dutch language;
  • presence of serious cardiovascular or cardiopulmonary conditions (e.g. unstable angina, arrhythmia or valve disease) such that exercise safety is at risk, as judged by the treating physician.
  • Already participating in structured vigorous aerobic and/or resistance exercise ≥ 2 times per week comparable to our intervention

About Radboud University Medical Center

Radboud University Medical Center is a leading academic medical institution located in Nijmegen, the Netherlands, dedicated to advancing healthcare through innovative research and education. As a prominent sponsor of clinical trials, Radboud UMC leverages its multidisciplinary expertise to conduct high-quality research that aims to improve patient outcomes and enhance medical knowledge. The center is committed to ethical standards and regulatory compliance, fostering collaboration among researchers, healthcare professionals, and patients to translate scientific discoveries into effective clinical applications. With a focus on personalized medicine and cutting-edge technologies, Radboud University Medical Center plays a pivotal role in shaping the future of healthcare through its rigorous clinical trial initiatives.

Locations

Arnhem, , Netherlands

Eindhoven, , Netherlands

Den Bosch, , Netherlands

Amsterdam, , Netherlands

Almere, , Netherlands

Nijmegen, Gelderland, Netherlands

Amersfoort, , Netherlands

Utrecht, , Netherlands

Amstelveen, , Netherlands

Amsterdam, , Netherlands

Breda, , Netherlands

Hoofddorp, , Netherlands

Nijmegen, , Netherlands

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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