The effects of neoadjuvant chemoradiotherapy and an in-hospital exercise training programme on physical fitness and quality of life in locally advanced rectal cancer patients: A randomised controlled trial (The EMPOWER Trial)

Abstract BackgroundThe EMPOWER trial aimed to assess the effects of a 9-week exercise prehabilitation programme on physical fitness compared with a usual care control group. Secondary aims were to investigate the effect of 1) the exercise prehabilitation programme on psychological health; and 2) neoadjuvant chemoradiotherapy (NCRT) on physical fitness and psychological health.MethodsBetween October 2013 and December 2016, adults with locally advanced rectal cancer undergoing standardised NCRT and surgery were recruited to a multi-centre trial. Patients underwent cardiopulmonary exercise testing (CPET) and HRQoL questionnaires (EORTC-QLQ-C30 and EQ-5D-5L) pre-NCRT and post-NCRT (week 0/baseline). At week 0, patients were randomised to exercise prehabilitation or usual care (no intervention). CPET and HRQoL questionnaires were assessed at week 0, 3, 6 and 9, whilst semi structured interviews were assessed at week 0 and week 9. Changes in oxygen uptake at anaerobic threshold (VO2 at AT (ml.kg− 1.min− 1)) between groups was compared using linear mixed modelling.ResultsThirty-eight patients were recruited, mean age 64 (10.4) years. Of the 38 patients, 33 were randomised: 16 to usual care and 17 to exercise prehabilitation (26 male and seven female). Exercise prehabilitation significantly improved VO2 at AT compared to the usual care. The change from baseline to week 9, when adjusted for baseline, between the randomised groups was + 2.9 ml.kg− 1.min− 1; 95% CI (0.8 to 5.1); p = 0.011.ConclusionA 9-week exercise prehabilitation programme significantly rescued fitness following NCRT. These findings have informed the WesFit trial (NCT03509428) which is investigating the effects of community-based multimodal prehabilitation before cancer surgery.Trial registrationClinicalTrials.gov NCT01914068. Registered 1 August 2013, https://clinicaltrials.gov/ct2/show/NCT01914068.