THE PROTECT TRIAL - PREOPERATIVE EXERCISE THERAPY FOR PATIENTS WITH CANCER: A PILOT RANDOMISED-CONTROLLED TRIAL

Abstract

INTRODUCTION & AIMS Prehabilitation exercise is a promising strategy in oncology to optimise pre-operative cardiorespiratory fitness (CRF), which could reduce post-operative complications, mortality and enhance quality of life. This trial aimed to investigate the safety, feasibility, and effects of an aerobic prehabilitation exercise program in breast, colorectal, and prostate cancer patients. Primary outcomes were serious adverse events (SAE), adverse events (AE), participant adherence and compliance. Secondary outcomes were CRF variables and patient well-being. METHODS A CONSORT-compliant pilot randomised controlled trial (RCT) was conducted at a regional hospital in Ballarat, Australia. Prostate, breast, and colorectal cancer patients scheduled for surgery were randomised 1:1 into prehabilitation (PREHAB) or usual care (UCARE). PREHAB involved aerobic exercises informed by baseline cardio-pulmonary testing findings, with supervised sessions every two/three days for a minimum of 2-weeks. UCARE involved standard oncology treatment. Data on physical activity (actigraphy), resting vitals, and post-operative outcomes (Clavien-Dindo) were also collected. RESULTS Among 47 approached patients, 23 were randomised. Overall, 11 patients were analysed in the PREHAB and 9 in the UCARE groups. No SAEs were reported, and an exercise-related AE occurred every 756 minutes (total 3780). Participants attended 91.3% of PREHAB sessions. PREHAB participants attended 5.25 (SD = 2.16) sessions and had an average of 15 days from baseline testing to surgery. No significant time x group interactions were observed in V̇O2peak, ventilatory threshold (VT), or overall patient well-being (p = 0.90, 0.58, 0.82); PREHAB achieved small within-group increases in absolute V̇O2peak and VT (+4.9% and +1.8%, respectively). CONCLUSIONS The PROTECT trial demonstrated the safety and feasibility of delivering prehabilitation, revealing small clinically relevant increases in CRF fitness measures. Potentially due to the sample size, no significant improvements were observed in well-being or post-operative complications; future research should prioritise larger-scale RCTs further to explore the benefits of prehabilitation in this population.