Bladder cancer and exercise training during intravesical therapy – the BRAVE trial: a study protocol for a phase II, prospective, single-center randomized controlled trial
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BMJ Open. Sep 24, 2021; 11 (9): e055782. doi: 10.1136 / bmjopen-2021-055782.
INTRODUCTION: Non-muscle invasive bladder cancer (NMIBC) accounts for approximately 75% of newly diagnosed bladder cancers. Treatment of NMIBC involves surgical removal of the tumor followed by 6 weekly instillations of immunotherapy or chemotherapy directly into the bladder (i.e. intravesical therapy). NMIBC has a high rate of recurrence (31% -78%) and progression (15%). In addition, bladder cancer and its treatment can affect the functioning and quality of life of patients. Exercise is a safe and effective intervention for many groups of cancer patients, however, no studies have examined exercise during intravesical treatment for NMIBC. The primary objective of the BRAVE trial (Bladder Cancer and Exercise Training During Intravesical Therapy) is to examine the safety and feasibility of an exercise intervention in patients with cancer of the bladder. bladder following intravesical therapy. The secondary objectives are to study the preliminary effectiveness of exercise on health-related fitness and the outcomes reported by patients; examine social cognitive predictors of exercise adherence; and explore the potential effects of exercise on tumor recurrence and progression.
METHODS AND ANALYSIS: BRAVE is a phase II randomized controlled trial which aims to include 66 patients with NMIBC who are scheduled to receive intravesical treatment. Participants will be randomly assigned to the exercise intervention or usual care. The intervention consists of three high-intensity supervised interval training sessions per week for 12 weeks. Feasibility will be assessed based on eligibility, recruitment, membership and attrition rates. Preliminary efficacy will focus on changes in cardiorespiratory condition and patient reported outcomes from baseline (before intravesical treatment) to pre-cystoscopy (3 months). Cancer results will be followed up at 3 months and followed up at 1 year by cystoscopy. Analysis of covariance will compare the differences between groups after the procedure (pre-cystoscopy) for all health and fitness outcomes reported by patients.
ETHICS AND DISSEMINATION: The study was approved by the Health Research Ethics Board of Alberta-Cancer Committee (# 20-0184). The dissemination will include publications and presentations at scientific conferences and public channels.
TEST REGISTRATION NUMBER: NCT04593862; Pre-results.