Clinical trial NCT04593862: Bladder Cancer and ExeRcise Training During IntraVesical ThErapy
Official title: Feasibility and Preliminary Efficacy of High-Intensity Interval Training in Bladder Cancer Patients Receiving Intravesical Therapy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bladder Cancer
Keywords: Non-muscle invasive bladder cancer
Exercise
High-intensity interval training
Randomized Controlled Trial
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Northern Alberta Urology Centre
name: Cross Cancer Institute
First posted: 2020-10-20
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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 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 stage cis, Ta or T1), and (3) are scheduled to receive induction intravesical therapy with chemotherapy (e.g., Gemcitabine or Mitomycin) or immunotherapy (e.g., BCG) agents.

Exclusion Criteria:

* Exclusion criteria for participants include: (1) not being medically cleared to participate in the exercise intervention by their treating urologist and a certified exercise physiologist using the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+), (2) having contraindications for cardiopulmonary stress and/or physical fitness tests, (3) already exercising according to the Godin Leisure-Time Exercise Questionnaire (GLTEQ), (4) not having the ability to read and comprehend English, and (5) not willing to be randomized to a supervised exercise training program or usual care (no exercise) for 12 weeks.

Primary outcomes:
measure: Changes of Peak Oxygen Consumption (VO2peak)
timeFrame: At baseline, after the intravesical therapy (6-week), and 3-month follow-up
Secondary outcomes:
measure: Lower body strength
timeFrame: At baseline, after the intravesical therapy (6-week), and 3-month follow-up
measure: Upper body strength
timeFrame: At baseline, after the intravesical therapy (6-week), and 3-month follow-up
measure: Lower body Flexibility
timeFrame: At baseline, after the intravesical therapy (6-week), and 3-month follow-up
measure: Upper body Flexibility
timeFrame: At baseline, after the intravesical therapy (6-week), and 3-month follow-up
measure: Agility
timeFrame: At baseline, after the intravesical therapy (6-week), and 3-month follow-up
measure: Functional Capacity
timeFrame: At baseline, after the intravesical therapy (6-week), and 3-month follow-up
measure: Anthropometry and body composition measurements
timeFrame: At baseline, after the intravesical therapy (6-week), and 3-month follow-up
measure: Health-related quality of life (HRQoL)
timeFrame: At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
measure: Bladder Cancer-Specific Quality of Life
timeFrame: At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
measure: Fear of cancer recurrence/progression
timeFrame: At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
measure: Anxiety
timeFrame: At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
measure: Depression
timeFrame: At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
measure: Perceived Stress
timeFrame: At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
measure: Fatigue
timeFrame: At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
measure: Self-esteem
timeFrame: At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
measure: Sleep quality
timeFrame: At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
measure: Social cognitive predictors of exercise adherence: motivation, perceived benefits, enjoyment, support from others, self-efficacy, and barriers
timeFrame: At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
Other outcomes:
measure: Complete response
timeFrame: 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy) and one-year follow-up
measure: Intravesical therapy adherence
timeFrame: 6-week follow-up
measure: Treatment toxicities
timeFrame: 6-week follow-up
measure: Incidence of Adverse events related to the High-Intensity Interval Training during Intravesical Therapy
timeFrame: Through study completion, an average of 1 year
measure: Eligibility rate of non-muscle invasive bladder cancer patients to a high-intensity interval
timeFrame: At baseline
measure: Recruitment rate of non-muscle invasive bladder cancer patients to a high-intensity interval training during Intravesical Therapy
timeFrame: At baseline
measure: Adherence rate of non-muscle invasive bladder cancer patients to a high-intensity interval
timeFrame: Through exercise intervention completion, an average of 12-weeks
measure: Follow-up assessment rate of non-muscle invasive bladder cancer patients to a high-intensity interval program during Intravesical Therapy
timeFrame: After the intravesical therapy (6-week), at the 3-month follow-up, and at 1 year follow-up
Locations:
city: Edmonton
country: Canada
facility: Fernanda Zane Arthuso
state: Alberta
Study officials:
affiliation: University of Alberta
name: Kerry S Courneya
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arthuso FZ, Fairey AS, Boule NG, Courneya KS. Bladder cancer and exeRcise trAining during intraVesical thErapy-the BRAVE trial: a study protocol for a prospective, single-centre, phase II randomised controlled trial. BMJ Open. 2021 Sep 24;11(9):e055782. doi: 10.1136/bmjopen-2021-055782.