Study  protocol for a randomised controlled trial

Loughney, Lisa; West, Malcolm; Kemp, Graham; Rossiter, Harry; Burke, Shaunna; Cox, Trevor;
Barben, Christopher; Mythen, Michael; Calverley, Peter; Palmer, Daniel;
Grocott, Michael; Jack, Sandy.

Trials, December 2016, Vol. 17 Issue: Number 1 p1-13, 13p;

Abstract: The standard treatment pathway for
locally advanced rectal cancer is neoadjuvant chemoradiotherapy (CRT)
followed by surgery. Neoadjuvant CRT has been shown to decrease
physical fitness, and this decrease is associated with increased
post-operative morbidity. Exercise training can stimulate skeletal
muscle adaptations such as increased mitochondrial content and improved
oxygen uptake capacity, both of which are contributors to physical
fitness. The aims of the EMPOWER trial are to assess the effects of
neoadjuvant CRT and an in-hospital exercise training programme on
physical fitness, health-related quality of life (HRQoL), and physical
activity levels, as well as post-operative morbidity and cancer
staging. The EMPOWER Trial is a randomised controlled
trial with a planned recruitment of 46 patients with locally advanced
rectal cancer and who are undergoing neoadjuvant CRT and surgery.
Following completion of the neoadjuvant CRT (week 0) prior to surgery,
patients are randomised to an in-hospital exercise training programme
(aerobic interval training for 6 to 9 weeks) or a usual care control
group (usual care and no formal exercise training). The primary
endpoint is oxygen uptake at lactate threshold (VO2 at AT)
measured using cardiopulmonary exercise testing assessed over several time points throughout the
study. Secondary endpoints include HRQoL, assessed using
semi-structured interviews and questionnaires, and physical activity
levels assessed using activity monitors. Exploratory endpoints include
post-operative morbidity, assessed using the Post-Operative Morbidity
Survey (POMS), and cancer staging, assessed by using magnetic resonance
tumour regression grading.   The EMPOWER trial is the
first randomised controlled trial comparing an in-hospital exercise
training group with a usual care control group in patients with locally
advanced rectal cancer. This trial will allow us to determine whether
exercise training following neoadjuvant CRT can improve physical
fitness and activity levels, as well as other important clinical
outcome measures such as HRQoL and post-operative morbidity. These
results will aid the design of a large, multi-centre trial to determine
whether an increase in physical fitness improves clinically relevant
post-operative outcomes.