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 (The EMPOWER Trial): study protocol for a randomised controlled trial

摘要: 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 associated with increased post-operative morbidity. Exercise training can stimulate skeletal muscle adaptations such as mitochondrial content improved oxygen uptake capacity, both of which are contributors fitness. aims the EMPOWER trial assess effects an in-hospital exercise programme on health-related quality life (HRQoL), activity levels, well morbidity staging. Trial a randomised controlled planned recruitment 46 patients who undergoing Following completion (week 0) prior surgery, (aerobic interval 6 9 weeks) or usual care control group (usual no formal training). primary endpoint at lactate threshold ( $$ \overset{\cdotp }{\mathrm{V}}{\mathrm{o}}_2 $$ {\widehat{\uptheta}}_{\mathrm{L}} ) measured using cardiopulmonary testing assessed over several time points throughout study. Secondary endpoints include HRQoL, semi-structured interviews questionnaires, levels monitors. Exploratory morbidity, Post-Operative Morbidity Survey (POMS), staging, magnetic resonance tumour regression grading. first comparing in cancer. This will allow us determine whether following improve fitness other important clinical outcome measures HRQoL These results aid design large, multi-centre increase improves clinically relevant outcomes. ClinicalTrials.gov NCT01914068 (received: 7 June 2013). Sponsor: University Hospital Southampton NHS Foundation Trust.