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

ConditionsBladder CancerRadiation Cystitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorNational Cancer Center, Korea

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Normal Saline (NS)

    Other intervention

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

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupSham comparator 1 intervention

Trial outcomes

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.

Time frame
12 months

Secondary outcomes

1

Tumor Control

To evaluate tumor control rates in patients with bladder cancer undergoing radiotherapy.

Time frame
12 months
2

Radiation-induced cystitis

To assess the incidence and severity of radiation-induced cystitis using RTOG/EORTC criteria.

Time frame
12 months
3

healthcare costs

To compare healthcare costs between the treatment group receiving intravesical hyaluronic acid instillation and the control group.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Cancer Center, Korea

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: