Intravesical Hyaluronic Acid (HA) for Preventing Radiation Cystitis on Bladder Cancer (NCT07125924) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Intravesical Hyaluronic Acid (HA) for Preventing Radiation Cystitis on Bladder Cancer
South Korea54 participantsStarted 2025-08-22
Plain-language 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.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. Pathologic confirmed Muscle-Invasive Urothelial Carcinoma I. Clinical stage: T2-T4a MIBC II. No or limited nodal involvement (N0 or partial N1, only isolated or regional) III. No distant metastasis (M0) IV. Transurethral resection of bladder tumor (TURBT): Maximal TURBT is available \> Most tumors must be resected, and residual disease should be minimized.
✓. Age ≥ 19
✓. Karnofsky performance score (KPS) ≥ 70 or ECOG performance status 0\~2
✓. Patients who are candidates for bladder-preserving therapy, specifically those scheduled to undergo concurrent chemoradiotherapy (CCRT) instead of radical cystectomy.
✓. Patients scheduled to receive radiotherapy in combination with one or more of the following chemotherapeutic agents prior to study enrollment: Cisplatin-based chemotherapy (e.g. weekly cisplatin), Gemcitabine or 5-FU/mitomycin, in accordance with standard clinical practice.
✓. Written informed consent obtained from the patients prior to study participation
Exclusion criteria
✕. Present of distant metastasis (M1)
✕. Tumor invasion beyond the bladder wall into adjacent organs (T4b)
✕. Non-urothelial carcinoma (including histologic variant) or predominant of non-urothelial components in mixed histology
✕. Medically inoperable status or poor general condition (ECOG performance status \> 2)
. History of active cystitis or recurrent urinary tract infections within the past 6 months
✕. Known hypersensitivity to hyaluronic acid or related compounds
✕. Any condition in which, in the investigator's judgment, administration of the study drug or procedure is deemed inappropriate
✕. Pregnant or breastfeeding women, or women of childbearing potential who are unable or unwilling to use adequate contraception during the study period