Background
The phase III Canadian Cancer Trials Group CO.21/CHALLENGE trial, demonstrated a 3-year structured exercise program (SEP) led to significantly improved disease-free and overall survival compared to health education materials (HEM) alone after adjuvant chemotherapy for colon cancer. Here, we report quality-of-life (QOL) and objective fitness outcomes.
Methods
Six a priori key secondary endpoints related to QOL were SF-36 physical function and physical component scores, FACT-Fatigue (fatigue subscale and FACT-G), HADS depression subscale, and PSQI subjective sleep quality. Fitness outcomes included the 6 Senior Fitness Test (SFT) components. Analyses included cross-sectional analysis of mean changes from baseline, linear mixed modelling of central trends, comparisons of proportions of patients improved/worsened, and sensitivity analyses.
Results
445 participants were randomized to SEP; 444 to HEM alone. PRO completion rates: baseline >95%; 24-months >70%. Mean change scores from baseline showed significant between-arm differences at 6-months for all key PRO domains. Between-arm differences in SF-36 physical were sustained to 36-months. Generalised linear modelling confirmed a significant positive impact of the intervention for all 6 measures. Analysis of proportions improved/unchanged/worsened at each time-point: more SEP improved in physical functioning (59% vs 44%), and fewer worsened (20% vs 30%, p< 0.001). SEP participants had significantly greater improvement across all six SFT measures at most post-baseline assessments.
Conclusions
A structured exercise program improved survival and overall QOL, physical functioning, sleep quality and physical fitness, and reduced fatigue and depression in colon cancer patients after adjuvant chemotherapy. Benefits were observed early and sustained across many outcomes. Referral pathways to a structured exercise program should be standard of care for adjuvant colon cancer survivors.