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.
Study Design: Single-blind, Randomized, Controlled trial. * Primary endpoint \- To assess patient-reported outcomes (PROs) related to symptoms of radiation-induced cystitis in patients with bladder cancer undergoing radiotherapy. * Secondary endpoint * To evaluate tumor control rates in patients with bladder cancer undergoing radiotherapy. * To assess the incidence and severity of radiation-induced cystitis using RTOG/EORTC criteria, CTCAE grading, and cystoscopic findings. * To compare healthcare costs between the treatment group receiving intravesical hyaluronic acid instillation and the control group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
54
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.
Normal saline will be instilled into the bladder following the same schedule as the intervention group, i.e., five times after each radiotherapy session.
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, South Korea
Primary endpoint
To assess patient-reported outcomes (PROs) related to symptoms of radiation-induced cystitis using the EORTC QLQ-BLM30 questionnaire (Korean version) in patients with bladder cancer undergoing radiotherapy.
Time frame: 12 months
Tumor Control
To evaluate tumor control rates in patients with bladder cancer undergoing radiotherapy.
Time frame: 12 months
Radiation-induced cystitis
To assess the incidence and severity of radiation-induced cystitis using RTOG/EORTC criteria.
Time frame: 12 months
healthcare costs
To compare healthcare costs between the treatment group receiving intravesical hyaluronic acid instillation and the control group.
Time frame: 12 months
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