metastatic colorectal cancer
Conditions
Interventions
 
Participants will be randomized into one of three study arms: 1) Continuous 
aerobic exercise (moderate intensity) combined with resistance exercise aiming 
to maintain muscle mass for 60 minutes twice a week
2) Continuous aerobic 
exercise (moderate intensity) combined with high-intensity aerobic interval 
exercise aiming to maintain aerobic fitness for 60 minutes twice a week
and 3) 
a usual care control group that receives usual care. Both intervention groups 
will be asked to be physically active an additional third time a week (for at 
least 30 min with moderate intensity) on their own according to the American 
College of Sports Medicine (ACSM) guidelines [26]. 
The intervention starts with the first cycle of chemotherapy and will continue 
until the end of the sixth cycle (3-week cycle) or the eight cycle (2-week 
cycle). After completion, 3 sessions will be offered to guide self-management 
to maintain exercise levels on their own. Patients from both intervention 
groups will be asked to stay physically active for 3 times a week and to keep 
doing the same sort of exercises as prescribed in the first period (T0-T2), 
i.e., resistance versus aerobic interval exercises. The intervention ends 
after 27 weeks or ends in case of disease progression or treatment switch to 
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 2 (feasbility): 1. recruitment 2. adherence and compliance 3. participant*s and counsellors satisfaction, perceived facilitators and barriers for implementation 4. contamination 5. adverse events Phase 3 (effects): 1. Chemotherapy dose modifications (dose reductions, treatment delay, discontinuation or switch) 2. Progression free survival (PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Both phase 2 & 3: 1. clinical data -treatment-related toxicity -treatment modifications (dose reductions, treatment delay, discontinuation, or switch) / primary outcome in phase 3 trial -hospitalization 2. aerobic fitness 3. Immune function 4. muscle strength and mass 5. physical activity (objective and self-report) 6. physical performance (age > 70) 7. Patient reported outcomes: HRQoL, symptoms related to mCRC and its treatment, resilience and self-efficacy. 8. Demographic and clinical covariables (tumor stage and location, ECOG, nutritional status)9. Diversity and abundance of oral and gut microbiome | — |
Countries
Netherlands
Contacts
Public ContactL.M. Buffart
Radboud Universitair Medisch Centrum
Outcome results
None listed