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

NCT07125924 | Not Yet Recruiting

• 1 other identifier: National Cancer Center, Korea
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hyaluronic acid; Radiation Cystitis; Intravesical treatment; Prevention

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (3)

• Tumor Control

  12 months

• Radiation-induced cystitis

  12 months

• healthcare costs

  12 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Blad-Care (sodium hyaluronate 1.6%, 800 mg/50 mL, BioPlus Co., Ltd.)

Device: Blad-Care (sodium hyaluronate 1.6%, 800 mg/50 mL, BioPlus Co., Ltd.)

Control group

SHAM COMPARATOR

Normal saline (N.S.)

Other: Normal Saline (NS)

Interventions

Blad-Care (sodium hyaluronate 1.6%, 800 mg/50 mL, BioPlus Co., Ltd.) DEVICE

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.

Intervention group

Normal Saline (NS) OTHER

Normal saline will be instilled into the bladder following the same schedule as the intervention group, i.e., five times after each radiotherapy session.

Control group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, 10408, South Korea

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Sung Uk Lee, MD, PhD

  Center for Proton Therapy, National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eui Hyun Jung, PhD

CONTACT

821046593407; jeh0315@ncc.re.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: August 3, 2025
• First Posted: August 15, 2025
• Study Start: August 22, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)