A prospective, single-center, phase II randomized controlled trial to evaluate the safety, feasibility, and preliminary efficacy of exercise during intravesical therapy for nonmuscle invasive bladder cancer.

TPS600 Background: Non-muscle invasive bladder cancer (NMIBC) accounts for about 75% of newly diagnosed bladder cancers. The treatment for NMIBC initially involves transurethral resection of the bladder tumor followed by six weeks of induction intravesical therapy. NMIBC has a high rate of recurrence (31-78%) and progression (15%). Moreover, bladder cancer and its treatments may affect patient functioning, quality of life, and increase the risk of cardiovascular mortality. Exercise is a safe and effective intervention for many cancer patients groups, however, no studies have examined exercise during intravesical therapy for NMIBC. Bladder cancer and exeRcise trAining during intraVesical thErapy (BRAVE) is the first phase II randomized controlled trial designed to evaluate the safety, feasibility, and preliminary efficacy of exercise for NMIBC patients during intravesical therapy. An exploratory aim is to track the short-term bladder cancer recurrence and progression rates for each trial arm. Methods: BRAVE has a target sample size of 66 men or women diagnosed with NMIBC undergoing intravesical therapy with chemotherapy or immunotherapy agents. Participants are being randomly assigned to usual care or exercise intervention, which consists of three supervised, high-intensity interval training sessions/week for 12-weeks. Safety is being evaluated by any adverse events during the physical fitness assessments or exercise sessions. Feasibility will be evaluated by eligibility, recruitment, adherence, and attrition rates. Preliminary efficacy endpoints are cardiorespiratory fitness assessed by peak oxygen consumption (VO2peak) at 6-week (post-intravesical therapy) and 3-month surveillance cystoscopy; and complete response (CR), defined as negative cytology, imaging, and cystoscopy and, when indicated, a negative biopsy. CR will be assessed at 3-month and one-year surveillance cystoscopy follow-up. Statistical analyses will follow the intention-to-treat approach. Analysis of covariance will compare between-group VO2peak differences at post-intervention (pre-cystoscopy). Study enrolment started May 24, 2021 and is ongoing. As of October 4, 2021, we have screened 17 NMIBC patients scheduled for intravesical therapy for eligibility; 16 (94%) were ineligible for medical (n = 11), language (n = 3), or location (n = 2) reasons. All the medical reasons included severe cardiovascular diseases. One eligible patient declined due to travel distance to the facility. In the face of a slower-than-expected recruitment rate, eligibility was extended to patients in the maintenance phases of treatment for NMIBC, where patients receive three weekly instillations of intravesical therapy. Clinical trial information: NCT04593862.