Exercise to improve outcomes in colorectal cancer patients
Aerobic Fitness or Muscle Mass Training to Improve Colorectal Cancer Outcome (AMICO). The Effects of Exercise on Chemotherapy Dose Modification and Progression Free Survival in Patients With Metastatic Colorectal Cancer
This study is testing whether aerobic and resistance exercise can help people with metastatic colorectal cancer feel better and handle chemotherapy without needing to change their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 228 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Radboud University Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 13 sites ('s-Hertogenbosch and 12 other locations) |
| Trial ID | NCT04754672 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of aerobic and resistance exercise on patients with metastatic colorectal cancer undergoing palliative chemotherapy. It aims to determine whether exercise can reduce chemotherapy-related toxicity and prevent dose modifications, which are common in this patient population. The study will compare different types of exercise interventions to identify the optimal approach for enhancing physical fitness and quality of life during treatment. By exploring the relationship between exercise and cancer outcomes, the research seeks to provide evidence for integrating exercise into standard cancer care.
Who should consider this trial
Good fit: Ideal candidates are patients with metastatic colorectal cancer who are scheduled for first-line palliative chemotherapy.
Not a fit: Patients with a life expectancy of less than six months or those unable to perform basic daily activities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes and quality of life for colorectal cancer patients undergoing chemotherapy.
How similar studies have performed: Previous studies have shown positive effects of exercise on cancer treatment outcomes, but this specific approach is novel and aims to clarify optimal exercise prescriptions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
's-Hertogenbosch and 12 other locations
- Jeroen Bosch Ziekenhuis — 's-Hertogenbosch, Netherlands (Recruiting)
- Flevoziekenhuis — Almere Stad, Netherlands (Recruiting)
- Meander Medisch Centrum — Amersfoort, Netherlands (Recruiting)
- Ziekenhuis Amstelland — Amstelveen, Netherlands (Recruiting)
- Amsterdam UMC — Amsterdam, Netherlands (Recruiting)
- Netherlands Cancer Institute — Amsterdam, Netherlands (Recruiting)
- Rijnstate Ziekenhuis — Arnhem, Netherlands (Recruiting)
- Ziekenhuis Amphia — Breda, Netherlands (Recruiting)
- Catharina Ziekenhuis — Eindhoven, Netherlands (Recruiting)
- Spaarne Gasthuis — Hoofddorp, Netherlands (Recruiting)
- Radboudumc — Nijmegen, Netherlands (Recruiting)
- Canisius Wilhelmina Ziekenhuis — Nijmegen, Netherlands (Recruiting)
- Umcu — Utrecht, Netherlands (Recruiting)
Study contacts
- Study coordinator: Laurien M Buffart, PhD
- Email: laurien.buffart@radboudumc.nl
- Phone: +31243613674
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.