NL-OMON54043RecruitingNot Applicable
Aerobic fitness or Muscle mass training to Improve Colorectal cancer Outcomes (AMICO): to study safe and feasible exercise dosages (phase 2) and the effects of exercise on chemotherapy dose modifications and progression free survival (phase 3) in patients with metastatic colorectal cancer. - AMICO
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 228
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •-age >=18 years;
- •-mCRC with indication for chemotherapy, with initially unresectable metastatic
- •-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
Investigators
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