Bladder Cancer and exeRcise Training During intraVesical thErapy

Bladder Cancer Clinical Trial

— BRAVE  

Official title:

Feasibility and Preliminary Efficacy of High-Intensity Interval Training in Bladder Cancer Patients Receiving Intravesical Therapy: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04593862
• Other study ID #: HEBRA - CC 20-0184
• Status: Recruiting
• Phase: Phase 2
• Start date: December 9, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: May 2024
• Source: University of Alberta
• Contact: Fernanda Z Arthuso
• Phone: 7804922829
• Email: arthuso[@]ualberta.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Other:
• High-Intensity Interval Training
The intervention will be performed on a treadmill and will include a warm-up and cool-down at 50-60% and 40% of the VO2peak respectively, for up to five minutes. The HIIT protocol will be 4x4, which consists of four bouts of four minutes at a workload corresponding to vigorous intensity (75-95% of the baseline and 6-week VO2peak) alternating with three minutes of recovery intervals at 40% of the VO2peak. The exercise session will last 35 minutes and include 16 minutes of high intensity exercise.

Locations

Country	Name	City	State
Canada	Fernanda Zane Arthuso	Edmonton	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
University of Alberta	Cross Cancer Institute, Northern Alberta Urology Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complete response	Negative cytology, imaging, and cystoscopy and, when the TURBT is indicated, a negative biopsy.	3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy) and one-year follow-up
Other	Intravesical therapy adherence	Intravesical therapy adherence will be tracked by medical records of attendance and self-report drug retention time	6-week follow-up
Other	Treatment toxicities	Treatment toxicities will be abstracted from medical records	6-week follow-up
Other	Incidence of Adverse events related to the High-Intensity Interval Training during Intravesical Therapy	To evaluate the safety of the program, any adverse events during the physical assessments (baseline, post- intravesical therapy, and post-intervention) and during the exercise sessions will be recorded.	Through study completion, an average of 1 year
Other	Eligibility rate of non-muscle invasive bladder cancer patients to a high-intensity interval	The eligibility rate will be the number of non-muscle invasive bladder cancer patients	At baseline
Other	Recruitment rate of non-muscle invasive bladder cancer patients to a high-intensity interval training during Intravesical Therapy	The recruitment rate will be the number of non-muscle invasive bladder cancer patients enrolled in the study divided by the number of eligible patients.	At baseline
Other	Adherence rate of non-muscle invasive bladder cancer patients to a high-intensity interval	Adherence to the program will be measured by the number of exercise sessions completed without dose modifications. Reasons for not completing the exercise session or for dose adjustments will be recorded.	Through exercise intervention completion, an average of 12-weeks
Other	Follow-up assessment rate of non-muscle invasive bladder cancer patients to a high-intensity interval program during Intravesical Therapy	The follow-up assessment rate will be determined by the number of participants who do not complete the post-intervention or follow-up assessments for any reason.	After the intravesical therapy (6-week), at the 3-month follow-up, and at 1 year follow-up
Primary	Changes of Peak Oxygen Consumption (VO2peak)	VO2 peak will be directly measured by the modified Bruce treadmill protocol exercise test, using a metabolic measurement system system (Parvo Medics TrueOne® 2400; Sandy, UT, USA).VO2peak will be defined as the highest oxygen-uptake value recorded during the test and will be expressed as relative to body mass (i.e., ml O2·kg-1·min-1).	At baseline, after the intravesical therapy (6-week), and 3-month follow-up
Secondary	Lower body strength	30-second chair stand; Scores are compared with normative data based on sex and age, with "normal" defined as the middle 50% of the population. Those scoring above this range would be considered above average for their age and those below the range as below average	At baseline, after the intravesical therapy (6-week), and 3-month follow-up
Secondary	Upper body strength	Arm curl; Scores are compared with normative data based on sex and age, with "normal" defined as the middle 50% of the population. Those scoring above this range would be considered above average for their age and those below the range as below average	At baseline, after the intravesical therapy (6-week), and 3-month follow-up
Secondary	Lower body Flexibility	Chair sit-and-reach; Scores are compared with normative data based on sex and age, with "normal" defined as the middle 50% of the population. Those scoring above this range would be considered above average for their age and those below the range as below average	At baseline, after the intravesical therapy (6-week), and 3-month follow-up
Secondary	Upper body Flexibility	Back Scratch; Scores are compared with normative data based on sex and age, with "normal" defined as the middle 50% of the population. Those scoring above this range would be considered above average for their age and those below the range as below average	At baseline, after the intravesical therapy (6-week), and 3-month follow-up
Secondary	Agility	8-foot up-and-go; Scores are compared with normative data based on sex and age, with "normal" defined as the middle 50% of the population. Those scoring above this range would be considered above average for their age and those below the range as below average	At baseline, after the intravesical therapy (6-week), and 3-month follow-up
Secondary	Functional Capacity	6-minute walk test; Scores are compared with normative data based on sex and age, with "normal" defined as the middle 50% of the population. Those scoring above this range would be considered above average for their age and those below the range as below average	At baseline, after the intravesical therapy (6-week), and 3-month follow-up
Secondary	Anthropometry and body composition measurements	Height, weight, waist, hip, and calf circumference	At baseline, after the intravesical therapy (6-week), and 3-month follow-up
Secondary	Health-related quality of life (HRQoL)	Assessment of health-related quality of life (HRQoL) using the European Organization for Research and Treatment of Cancer (EORTC) core 30-item questionnaire (QLQ-C30) version 3.0.; The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / quality of life scale, and six single items.; All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.	At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
Secondary	Bladder Cancer-Specific Quality of Life	European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for non-muscle invasive bladder cancer core 24-item (EORTC QLQ NMIBC C24).; EORTC QLQ NMIBC C24 is composed of scales assessing urinary symptoms, bowel symptoms, sexual, and side effects of intravesical treatment (fever, malaise, convenience of and worry due to repeated cystoscopies).; All of the scales a range in score from 0 to 100. A high scale score represents a higher response level.	At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
Secondary	Fear of cancer recurrence/progression	Fear of cancer recurrence/progression will be assessed by the Fear of Cancer Recurrence Inventory; Minimum: 0 Maximum:168 Higher score= higher levels of fear of cancer recurrence/progression	At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
Secondary	Anxiety	Anxiety will be assessed using the 10-item State-trait Anxiety Inventory.; Minimum: 20 Maximum: 80 Higher score= worse anxiety	At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
Secondary	Depression	Depression will be assessed using the Epidemiologic Studies Depression Scale (CES-D) questionnaire.; Minimum: 0 Maximum: 30 (cut off point: 10) Higher score= worse depression	At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
Secondary	Perceived Stress	Perceived stress will be assessed using the Perceived Stress Scale (PSS) questionnaire.; questionnaire.; Minimum: 0 Maximum: 56 Higher score=worse perceived stress	At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
Secondary	Fatigue	Fatigue will be assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire; Minimum: 0 Maximum: 52 Higher score=worse fatigue	At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
Secondary	Self-esteem	Self-esteem using the Rosenberg self-esteem scale; Minimum: 10 Maximum: 40 Higher score= better self-esteem	At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
Secondary	Sleep quality	Sleep quality will be assessed by the Insomnia Severity Index (ISI); Minimum: 0 Maximum: 28 Higher score= worse insomnia	At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up
Secondary	Social cognitive predictors of exercise adherence: motivation, perceived benefits, enjoyment, support from others, self-efficacy, and barriers	Standard scales for the Theory of Planned Behaviour	At baseline, 3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy), and at one-year follow-up