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Exercise Training for Bladder Cancer (BRAVE Trial)

Phase 2

Waitlist Available

Led By Kerry S Courneya

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Confirmed diagnosis of non-muscle invasive bladder cancer (clinical stage cis, Ta or T1)

Scheduled to receive induction intravesical therapy with chemotherapy (e.g., Gemcitabine or Mitomycin) or immunotherapy (e.g., BCG) agents

Must not have

Not willing to be randomized to a supervised exercise training program or usual care (no exercise) for 12 weeks

Contraindications for cardiopulmonary stress and/or physical fitness tests

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if supervised exercise can help bladder cancer patients who are receiving medication directly into their bladder. The study aims to see if exercise can improve their physical and mental well-being, manage side effects, and lower the chances of the cancer coming back.

Who is the study for?

This trial is for men and women over 18 with non-muscle invasive bladder cancer, scheduled for chemotherapy or immunotherapy. Participants must understand English and be medically cleared to exercise. Those already following a regular exercise routine or unwilling to be assigned randomly to an exercise program are excluded.

What is being tested?

The BRAVE Trial is testing the safety and effectiveness of high-intensity interval training during intravesical therapy for bladder cancer patients. It will compare outcomes between those who participate in supervised exercise programs and those who do not during their treatment.

What are the potential side effects?

While specific side effects aren't listed, exercising can sometimes lead to muscle soreness, fatigue, or injury if not done correctly. The study aims to ensure that high-intensity workouts are safe alongside bladder cancer treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My bladder cancer is not muscle-invasive.

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I am scheduled for bladder treatment with chemo or immunotherapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not open to being assigned randomly to an exercise program or no exercise for 12 weeks.

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I cannot undergo stress or fitness tests due to health reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes of Peak Oxygen Consumption (VO2peak)

Secondary study objectives

Agility

Anthropometry and body composition measurements

Anxiety

+14 more

Other study objectives

Adherence rate of non-muscle invasive bladder cancer patients to a high-intensity interval

Complete response

Eligibility rate of non-muscle invasive bladder cancer patients to a high-intensity interval

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Exercise GroupExperimental Treatment1 Intervention

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.

Group II: Usual Care:Active Control1 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.

0 / 4Eligibility criteria met