Structured Exercise after Adjuvant Chemotherapy for Colon Cancer
- Study type
- Clinical trial
- Study name
- CHALLENGE (CCTG CO.21)
- Phase
- Phase 3
- Design
- Multicentre randomised trial (55 centres)
- Sample size
- 889 patients
- Source
- N Engl J Med · 2025
- Trial registration
- NCT00819208
In plain words
People who, after surgery and chemotherapy for bowel cancer, did regular exercise with the help of a coach for 3 years were less likely to have their cancer come back and lived longer than those who received only an information leaflet.
Key results
Treatment arms and regimens
No drug (behavioural exercise intervention). A 36-month personalised physical activity programme with a physical activity consultant, plus health education materials. The physical activity prescription was tailored to baseline fitness testing, activity history, performance status and patient preference (mostly walking; any activity of at least moderate intensity was acceptable).
- Phase 1 (first 6 months, intensive): 12 mandatory in-person behavioural support sessions every two weeks plus 12 mandatory supervised physical activity sessions (12 further supervised sessions in alternate weeks were recommended); target: an increase of 10 MET-hours per week over baseline.
- Phase 2 (months 6 to 12, reduced): 12 mandatory in-person or telephone behavioural support sessions every two weeks, with 12 recommended supervised sessions; target: an increase of 20 MET-hours per week.
- Phase 3 (months 12 to 36, minimal): mandatory monthly in-person or telephone behavioural support sessions with recommended supervised sessions; target: up to a total of 27 MET-hours per week.
445 patients.
No drug: general health education materials only, given once at the start of the study (444 patients). Fitness testing and questionnaires were done as in the exercise group.
Source of the regimen details: No drug; structure, targets and sessions of the exercise intervention from ClinicalTrials.gov NCT00819208 (Arms/Interventions and Outline sections)
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
Patients with completely resected colon adenocarcinoma, stage 3 (at least one positive lymph node or tumour deposit) or high-risk stage 2 (T4, fewer than 12 nodes sampled or poorly differentiated), who had completed fluorouracil-based adjuvant chemotherapy (at least one cycle) 60 to 180 days before enrolment; CEA no more than 5 µg/L; physical activity below recommended levels (less than 150 minutes of moderate-to-vigorous or 75 minutes of vigorous activity per week); ECOG 0 or 1; no metastases or local recurrence on imaging within the previous 60 days; rectal cancer and prior radiotherapy to the primary tumour were exclusion criteria (ClinicalTrials.gov). 55 centres; enrolment from 2009 to 2024.
Endpoints
Primary endpoint: disease-free survival (recurrence, new primary cancer or death). Secondary endpoints: overall survival, adverse events and patient-reported outcomes.
Safety and side effects
Musculoskeletal adverse events were more frequent in the exercise group (18.5% vs 11.5%).
Clinical significance and place in guidelines
The first phase 3 trial to show that an exercise intervention improves disease-free survival in cancer; a preplanned economic analysis (JCO 2026) showed that the programme was both cheaper and more effective from the perspective of the Canadian public payer.
Limitations
Blinding was not possible; long enrolment period (15 years); overall survival was a secondary endpoint; implementation requires coaching infrastructure and behavioural support.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.