Feasibility, Safety, and Preliminary Efficacy of Exercise During and After Neoadjuvant Rectal Cancer Treatment: A Phase II Randomized Controlled Trial.
Level 2 - randomized trial
Individual randomized controlled trial
PubMed 34158253 · doi:10.1016/j.clcc.2021.05.004
What was done
A phase II randomized controlled trial (EXERT) evaluated the feasibility, safety, and preliminary efficacy of an exercise intervention in 36 patients with rectal cancer scheduled for neoadjuvant chemoradiation (NACRT). Participants were randomly assigned to usual care (n = 18) or an exercise intervention (n = 18) involving supervised exercise during NACRT and unsupervised exercise after NACRT. The primary outcome was cardiorespiratory fitness (VO2 peak); clinical outcomes included toxicities, treatment completion, and treatment response (pathologic complete response, pCR).
What was found
Median attendance at supervised exercise sessions during NACRT was 82%, and median self-reported exercise after NACRT was 90 min/wk. From baseline to post-NACRT, VO2 peak changed by +0.4 mL·kg⁻¹·min⁻¹ in the exercise group versus -0.8 mL·kg⁻¹·min⁻¹ in the usual care group (P = .47). There were no significant differences in grade 3/4 toxicities or treatment completion. Ten of 18 (56%) patients in the exercise group achieved a pCR or near-pCR compared with 3 of 17 (18%) in the usual care group (P = .020).
Why it matters
This study provides preliminary randomized evidence that structured exercise during and after neoadjuvant rectal cancer treatment is feasible and may enhance tumor response, supporting the need for adequately powered phase III trials.
Limits
The sample size was very small (n = 36), limiting statistical power for clinical endpoints. Post-NACRT exercise adherence was self-reported, one control participant was not evaluated for treatment response, and the change in the primary outcome (VO2 peak) was not statistically significant.
Cited by
- partial Cancer patients who exercise while undergoing chemoradiation therapy are more likely to achieve a complete pathological response prior to surgery.
- supports In a study of rectal cancer patients undergoing neoadjuvant chemoradiation, patients who exercised were more likely to achieve a complete pathological response prior to surgery.