Intravesical Hyaluronic Acid (HA) for Preventing Radiation Cystitis on Bladder Cancer
NCT07125924 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54
Last updated 2025-08-15
Summary
To evaluate the efficacy and safety of intravesical hyaluronic acid (HA) instillation therapy for the prevention of radiation-induced cystitis in patients undergoing radiotherapy for bladder cancer.
Conditions
- Bladder Cancer
- Radiation Cystitis
Interventions
- DEVICE
-
Blad-Care (sodium hyaluronate 1.6%, 800 mg/50 mL, BioPlus Co., Ltd.)
Bladder instillation of Blad-Care (sodium hyaluronate 1.6%, 800 mg/50 mL, BioPlus Co., Ltd.) will be administered aseptically once weekly for a total of five times following each session of radiotherapy.
- OTHER
-
Normal Saline (NS)
Normal saline will be instilled into the bladder following the same schedule as the intervention group, i.e., five times after each radiotherapy session.
Sponsors & Collaborators
-
National Cancer Center, Korea
lead OTHER_GOV
Principal Investigators
-
Sung Uk Lee, MD, PhD · Center for Proton Therapy, National Cancer Center, Korea
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-08-22
- Primary Completion
- 2027-12-31
- Completion
- 2027-12-31
Countries
- South Korea
Study Locations
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