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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

Loughney, Lisa, West, Malcolm A., Kemp, Graham J., Rossiter, Harry B., Burke, Shaunna M., Cox, Trevor, Barben, Christopher P., Mythen, Michael G., Calverley, Peter, Palmer, Daniel H., Grocott, Michael P.W. and Jack, Sandy (2016) 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 Trials, 17, (24), pp. 1-13. (doi:10.1186/s13063-015-1149-4). (PMID:26762365).

Record type: Article

Abstract

BACKGROUND: 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.

METHODS/DESIGN: 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 ([Formula: see text] at [Formula: see text]) 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.

DISCUSSION: 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.

TRIAL REGISTRATION: ClinicalTrials.gov NCT01914068 (received: 7 June 2013).

SPONSOR: University Hospital Southampton NHS Foundation Trust.

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Accepted/In Press date: 29 December 2015
Published date: 13 January 2016
Keywords: neoadjuvant chemoradiotherapy, exercise training, physical activity, surgery, surgical outcome
Organisations: Clinical & Experimental Sciences

Identifiers

Local EPrints ID: 389812
URI: http://eprints.soton.ac.uk/id/eprint/389812
ISSN: 1745-6215
PURE UUID: 5b187414-70d3-4eea-850c-7538a733af5f

Catalogue record

Date deposited: 15 Mar 2016 16:46
Last modified: 17 Jul 2017 19:32

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Contributors

Author: Lisa Loughney
Author: Malcolm A. West
Author: Graham J. Kemp
Author: Harry B. Rossiter
Author: Shaunna M. Burke
Author: Trevor Cox
Author: Christopher P. Barben
Author: Michael G. Mythen
Author: Peter Calverley
Author: Daniel H. Palmer
Author: Sandy Jack

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