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.

Recruiting

Conditions: coloncarcinoma
10017991

Registration Number: NL-OMON54043

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 228

Inclusion Criteria

-age >=18 years;
-mCRC with indication for chemotherapy, with initially unresectable metastatic
disease
-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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Phase 2 (feasbility):<br /><br>1. recruitment<br /><br>2. adherence and compliance<br /><br>3. participant*s and counsellors satisfaction, perceived facilitators and<br /><br>barriers for implementation<br /><br>4. contamination<br /><br>5. adverse events<br /><br><br /><br>Phase 3 (effects):<br /><br>1. Chemotherapy dose modifications (dose reductions, treatment delay,<br /><br>discontinuation or switch)<br /><br>2. Progression free survival (PFS)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Both phase 2 & 3:<br /><br>1. clinical data<br /><br>-treatment-related toxicity<br /><br>-treatment modifications (dose reductions, treatment delay,<br /><br>discontinuation, or switch) / primary outcome in phase 3 trial<br /><br>-hospitalization<br /><br>2. aerobic fitness<br /><br>3. Immune function<br /><br>4. muscle strength and mass<br /><br>5. physical activity (objective and self-report)<br /><br>6. physical performance (age > 70)<br /><br>7. Patient reported outcomes: HRQoL, symptoms related to mCRC and its<br /><br>treatment, resilience and self-efficacy.<br /><br>8. Demographic and clinical covariables (tumor stage and location, ECOG,<br /><br>nutritional status)</p><br>