Study on How Patient Position and BCG Dwell Time Affect Treatment for Non-Muscle Invasive Bladder Cancer

Sponsor: Ohio State University Comprehensive Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT07474519

This clinical trial is exploring whether the position a patient is in while receiving BCG treatment for bladder cancer affects how long the medication stays in the bladder, which could improve treatment outcomes.

Patient Parameters

Program Overview

This study is investigating if the position a patient is in during BCG treatment for non-muscle invasive bladder cancer affects how long the medication stays in the bladder. BCG has been used for over 40 years to treat this type of cancer, and it's important for the medication to stay in the bladder for a certain amount of time, usually 2 hours. However, some patients find it hard to hold the medication for that long due to bladder issues or movement restrictions. By studying the relationship between patient position and how long the medication stays in the bladder, researchers hope to improve treatment, especially for those with limited bladder capacity or severe urinary symptoms.

Description

The main goals of this study are to see if there's a link between how long BCG stays in the bladder and the position a patient is in during treatment, and to test if a fitness tracker can help monitor patient activity and health during treatment.

Here's how the study works:

  • Patients will receive standard BCG treatment once a week for three weeks, as long as their cancer doesn't get worse or they don't experience severe side effects.

  • During the first treatment, patients will receive BCG and be asked not to urinate for 2 hours, with no restrictions on activity.

  • During the second treatment, patients will receive BCG and stay lying down for as long as they can hold the medication, up to 2 hours.

  • During the third treatment, patients will receive BCG and stay sitting for as long as they can hold the medication, up to 2 hours.

  • Patients will also wear a Fitbit activity tracker throughout the study to monitor their activity and health.

Eligibility Criteria

Inclusion Criteria

  • Have intermediate or high risk non-muscle invasive bladder cancer and choose BCG treatment.
  • Have not started BCG treatment yet.
  • Can stay lying down for 2 hours (head can be raised on up to two pillows).
  • Can stay sitting for 2 hours.
  • Willing to wear a fitness tracker for at least five days during the study.
  • Can participate in a video or phone call.
  • Able to give informed consent.

Exclusion Criteria

  • Have received BCG treatment in the past year.
  • Cannot hold BCG in the bladder.
  • Have a history of urinary incontinence with a high score on a bladder survey.
  • Do not want to wear a fitness tracker during the study.

Locations

FACILITYZIPCITYSTATE
Ohio State University Comprehensive Cancer Center43210ColumbusOhio

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