Bladder Cancer and ExeRcise Training During IntraVesical ThErapy

NCT04593862 | Completed Phase 2

• 1 other identifier: HEBRA - CC 20-0184
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Keywords

Non-muscle invasive bladder cancer; Exercise; High-intensity interval training; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Lower body strength

  At baseline, after the intravesical therapy (6-week), and 3-month follow-up

• Upper body strength

  At baseline, after the intravesical therapy (6-week), and 3-month follow-up

• Lower body Flexibility

  At baseline, after the intravesical therapy (6-week), and 3-month follow-up

• Upper body Flexibility

  At baseline, after the intravesical therapy (6-week), and 3-month follow-up

• Agility

  At baseline, after the intravesical therapy (6-week), and 3-month follow-up

Other Outcomes (8)

• Complete response

  3-month (post-exercise intervention/prior to the 3-month surveillance cystoscopy) and one-year follow-up

• Intravesical therapy adherence

  6-week follow-up

• Treatment toxicities

  6-week follow-up

Study Arms (2)

Exercise Group

EXPERIMENTAL

The exercise intervention will consist of 36 high-volume high-intensity interval sessions over a 12-week period. The exercise frequency will be three times per week during the 6 weeks of intravesical therapy and the 6 weeks of recovery (total 12 weeks) prior to a surveillance cystoscopy.

Other: High-Intensity Interval Training

Usual Care:

NO INTERVENTION

Patients randomized to the control group will be asked not to initiate any exercise program or to increase their exercise level from baseline during the 12-week study. After the post-intervention assessments and 3-month cystoscopy, patients in the control group will be offered a 4-week supervised exercise program at the Behavioural Medicine Fitness Centre, University of Alberta.

Interventions

High-Intensity Interval Training OTHER

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.

Exercise Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead
• Northern Alberta Urology Centre: collaborator
• Cross Cancer Institute: collaborator

Study Sites (1)

Fernanda Zane Arthuso

Edmonton, Alberta, Canada

Location

Related Publications (1)

• 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.

  PMID: 34561265 DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms; Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kerry S Courneya

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and investigators will not be blinded to group assignment given the nature of the intervention. Outcome assessors will be blinded to group assignment for the clinical outcomes of tumour recurrence and progression.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: October 20, 2020
• Study Start: December 9, 2021
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)