Bladder Cancer and ExeRcise Training During IntraVesical ThErapy

Last updated: September 10, 2024
Sponsor: University of Alberta
Overall Status: Completed

Phase

2

Condition

Urothelial Carcinoma

Bladder Cancer

Urothelial Cancer

Treatment

High-Intensity Interval Training

Clinical Study ID

NCT04593862
HEBRA - CC 20-0184
  • Ages > 18
  • All Genders

Study Summary

Bladder cancer is the fifth most common cancer in Canada and has the eighth highest cancer mortality rate. The treatment for the most frequent type of bladder cancer is surgically removing the tumour followed by six weeks of medication placed within the bladder. There are physical and psychosocial challenges from bladder cancer and its treatment that may affect how patients feel and function, and consequently their quality of life. Moreover, bladder cancer patients are at a high risk of their bladder cancer coming back and getting worse. Exercise is a low-cost intervention that may lower the chances of bladder cancer coming back or getting worse, manage side effects related to treatment, help patients feel better, and improve quality of life. To date, however, no study has examined if it is safe or even possible for bladder cancer patients to exercise when they are receiving drugs placed into their bladder. The Bladder cancer and exeRcise trAining during intraVesical thErapy (BRAVE) Trial will be the first study to test the safety, feasibility, and efficacy of exercise in bladder cancer patients during this drug therapy. The investigators will ask some patients to do a supervised exercise program during their drug treatment while other patients will be asked not to exercise. The investigators will compare the 2 groups on how they fare with their bladder cancer treatment. This study will provide information on whether exercise may help patients feel better, function better, and possibly even lower their chances of the disease coming back or getting worse.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Eligible participants will include men and women that (1) are ≥ 18 years old, (2)have a confirmed diagnosis of non-muscle invasive bladder cancer (clinical stagecis, Ta or T1), and (3) are scheduled to receive induction intravesical therapy withchemotherapy (e.g., Gemcitabine or Mitomycin) or immunotherapy (e.g., BCG) agents.

Exclusion

Exclusion Criteria:

  • Exclusion criteria for participants include: (1) not being medically cleared toparticipate in the exercise intervention by their treating urologist and a certifiedexercise physiologist using the Physical Activity Readiness Questionnaire forEveryone (PAR-Q+), (2) having contraindications for cardiopulmonary stress and/orphysical fitness tests, (3) already exercising according to the Godin Leisure-TimeExercise Questionnaire (GLTEQ), (4) not having the ability to read and comprehendEnglish, and (5) not willing to be randomized to a supervised exercise trainingprogram or usual care (no exercise) for 12 weeks.

Study Design

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: High-Intensity Interval Training
Phase: 2
Study Start date:
December 09, 2021
Estimated Completion Date:
August 30, 2024

Connect with a study center

  • Fernanda Zane Arthuso

    Edmonton, Alberta
    Canada

    Site Not Available

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