Exercise for advanced prostate cancer: a multicomponent, feasibility, trial protocol for men with metastatic castrate-resistant prostate cancer (EXACT)

Abstract

Background Men with metastatic castrate-resistant prostate cancer can experience an array of treatment-related side effects. Accumulating evidence suggests exercise may alleviate some of these adversities and assist in disease management. However, empirical evidence in advanced prostate cancer patients remains limited. The purpose of this study is to determine whether men with metastatic prostate cancer, who are ineligible for high-intensity exercise, can partake in a home-based, moderate-intensity exercise program and the impact of doing so on quality of life and physical fitness parameters. Methods Thirty men with adenocarcinoma of the prostate and progressive systemic, metastatic disease will be recruited. Clinicians will screen patients against inclusion criteria to determine eligibility. All men enrolled will be prescribed a tailored, home-based, moderate-intensity exercise intervention consisting of aerobic and strengthening components for 12 weeks. Patients will receive supplementary education materials and weekly behavioural change consultations throughout the intervention. The primary outcome will be the feasibility of delivering such an intervention in men with metastatic disease. Secondary endpoints including skeletal events will be monitored for safety, as will the feasibility of patient-reported outcome measures and the sampling time points, generating data pertaining to completion rates and potential effect in future trials. General physical fitness will be assessed during these visits, using timed sit-to-stand testing and a 6-min walking test. Prior to each visit, objective physical activity levels will be captured for 7 days using an accelerometer, to determine the feasibility of this technology and the quality of data obtained. In parallel with the feasibility aspects of the trial, changes compared to baseline will be reported. Direct regular contact will also serve as a feedback loop, should any issues arise. This study has received ethical approval from the Office for Research Ethics Committees Northern Ireland. Conclusions This study aims to determine the potential utility of a home-based exercise intervention in managing side effects associated with advanced prostate cancer and its treatment. This feasibility trial will inform the design and implementation of a larger randomised control trial to determine the efficacy of moderate aerobic and strengthening exercise as an adjuvant therapy in men with metastatic prostate cancer. Collecting such evidence provides further support for exercise in this paradigm and potential for its inclusion as a low-toxicity therapy in standard cancer care, in the longer term. Trial registration ClinicalTrials.gov, NCT03658486 Trial sponsor: Queen’s University Belfast (Reference: B18/15). Contact: Dr. Paula Tighe, Research and Enterprise, Queen’s University Belfast. Telephone: 02890 973,296. Email: p.tighe@qub.ac.uk. The sponsor rev...

Feasibility of home-based exercise training during adjuvant treatment for metastatic castrate-resistant prostate cancer patients treated with an androgen receptor pathway inhibitor (EXACT)

“…This 12-week, home-based intervention has been described previously [ 31 ] and consisted of progressive, moderate-intensity walking and resistance exercise, 2–5 times per week (supplementary materials table 1 ). This intervention was designed in consultation with the ACSM exercise guidelines for oncology patients [ 30 ], with the aim of achieving these by week 9.…”

Efficacy and Safety of an mHealth App and Wearable Device in Physical Performance for Patients With Hepatocellular Carcinoma: Development and Usability Study

“…First, the study population was small and the intervention period was short. In most of the previously conducted feasibility or pilot studies regarding new protocols of exercise interventions among a cancer population, 10-30 patients were enrolled [36][37][38][39]. Since this was the first study to apply an IoT-based individualized exercise program among compensated HCC patients who had completed therapy, we considered that the final participant number of 31 was sufficient.…”

Usability, Acceptability, and Safety Analysis of a Computer-Tailored Web-Based Exercise Intervention (ExerciseGuide) for Individuals With Metastatic Prostate Cancer: Multi-Methods Laboratory-Based Study

“…The time-related demands and financial pressures faced by men with metastatic prostate cancer may lead to reluctance or inability to attend supervised clinic-based exercise programs [ 4 , 10 ]. Recently, Brown et al [ 11 ] commenced research into a home-based exercise approach for individuals with metastatic prostate cancer, which uses a one-time face-to-face exercise assessment, print-based material, and weekly telephone contact for remote supervision and behavioral change counseling. To further increase the scalability, accessibility, and adherence to home-based exercise, the addition of digital technologies to this type of home-based exercise intervention may be advantageous.…”