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Not yet recruiting NCT07125924

Intravesical Hyaluronic Acid (HA) for Preventing Radiation Cystitis on Bladder Cancer

No phase Interventional Bladder Cancer Radiation Cystitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blad-Care (sodium hyaluronate 1.6%, 800 mg/50 mL, BioPlus Co., Ltd.), Normal Saline (NS).
Who it may be relevant to
Registry conditions: Bladder Cancer, Radiation Cystitis. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Intravesical Hyaluronic Acid (HA) for Preventing Radiation Cystitis on Bladder Cancer : A Randomized Controlled Trial

Overview

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.

Detailed description

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.

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.

Primary outcome measures

  • Primary endpoint [Time frame: 12 months]
Secondary outcome measures (3)
  • Tumor Control [Time frame: 12 months]
  • Radiation-induced cystitis [Time frame: 12 months]
  • healthcare costs [Time frame: 12 months]

Eligibility criteria

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.

V. Preserved bladder function is required: patients must have normal bladder capacity and maintain adequate voiding function.

VI. Unifocal or localized tumor (except multifocal) VII. No extensive carcinoma in situ (CIS)

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

South Korea · 1 center
  • National Cancer Center, Korea — Goyang-si

Identifiers

NCT: NCT07125924 · National Cancer Center, Korea

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗