Status:
RECRUITING
Aerobic Fitness or Muscle Mass Training to Improve Colorectal Cancer Outcome
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
UMC Utrecht
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Colorectal Cancer
Chemotherapeutic Toxicity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Evidence from randomized controlled trials shows that exercise during cancer treatment benefits physical fitness, fatigue and quality of life. Since the effect of exercise on clinical outcome is curre...
Detailed Description
First-line treatment of metastatic colorectal cancer (mCRC) generally includes the chemotherapies fluoropyrimidines in combination with oxaliplatin and/or irinotecan, known as doublet or triplet chemo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT04754672
Start Date
March 2 2021
End Date
December 1 2026
Last Update
November 18 2023
Active Locations (13)
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1
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands, 5223 GZ
2
Flevoziekenhuis
Almere Stad, Netherlands, 1315 RA
3
Meander Medisch Centrum
Amersfoort, Netherlands, 3813TZ
4
Ziekenhuis Amstelland
Amstelveen, Netherlands, 1186AM