Bladder CancerNCT07125924
Intravesical Hyaluronic Acid (HA) for Preventing Radiation Cystitis on Bladder Cancer
A study testing Blad-Care (sodium hyaluronate 1.6%, 800 mg/50 mL, BioPlus Co., Ltd.) and Normal Saline (NS) in people with Bladder Cancer and Radiation Cystitis, run by National Cancer Center, Korea at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bladder Cancer, Radiation Cystitis
- What is being tested?
- Blad-Care (sodium hyaluronate 1.6%, 800 mg/50 mL, BioPlus Co., Ltd.) and Normal Saline (NS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Aug 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Preserved bladder function is required: patients must have normal bladder capacity and maintain adequate voiding function.
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, 10408
Eui Hyun Jung, PhD, 82319202451, jeh0315@ncc.re.kr
About this study
Official title: Intravesical Hyaluronic Acid (HA) for Preventing Radiation Cystitis on Bladder Cancer : A Randomized Controlled 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.
Read the 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.
- Conditions
- Bladder Cancer, Radiation Cystitis
- Being tested
- Blad-Care (sodium hyaluronate 1.6%, 800 mg/50 mL, BioPlus Co., Ltd.), Normal Saline (NS)
- Keywords
- Hyaluronic acid, Radiation Cystitis, Intravesical treatment, Prevention
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Normal saline will be instilled into the bladder following the same schedule as the intervention group, i.e., five times after each radiotherapy session.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Blad-Care (sodium hyaluronate 1.6%, 800 mg/50 mL, BioPlus Co., Ltd.) Receives: Device: Blad-Care (sodium hyaluronate 1.6%, 800 mg/50 mL, BioPlus Co., Ltd.) |
| Control group | Sham comparator | Normal saline (N.S.) Receives: Other: Normal Saline (NS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
Tumor Control
To evaluate tumor control rates in patients with bladder cancer undergoing radiotherapy.
Measured: 12 months
Radiation-induced cystitis
To assess the incidence and severity of radiation-induced cystitis using RTOG/EORTC criteria.
Measured: 12 months
healthcare costs
To compare healthcare costs between the treatment group receiving intravesical hyaluronic acid instillation and the control group.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start22 Aug 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sung Uk Lee, National Cancer Center, Korea
- Investigators
- Sung Uk Lee, MD, PhD, Principal investigator, Center for Proton Therapy, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125924
- Sponsor's protocol ID
- National Cancer Center, Korea
- Status last verified
- Aug 2025
- First submitted
- 3 Aug 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravesical Hyaluronic Acid (HA) for Preventing Radiation Cystitis on Bladder Cancer : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07125924
- Acronym / sponsor ID
- National Cancer Center, Korea
- Conditions
- Bladder Cancer, Radiation Cystitis
- Keywords
- Hyaluronic acid, Radiation Cystitis, Intravesical treatment, Prevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- 22 Aug 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Blad-Care (sodium hyaluronate 1.6%, 800 mg/50 mL, BioPlus Co., Ltd.)Blad-Care (sodium hyaluronate 1.6%, 800 mg/50 mL, BioPlus Co., Ltd.) |
| Control group | Sham comparator | Other: Normal Saline (NS)Normal saline (N.S.) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Intervention group |
| 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. | Other | Control group |
Primary outcome
Primary endpoint
Time frame: 12 months
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.
3 secondary outcomes
Tumor Control
Time frame: 12 months
Radiation-induced cystitis
Time frame: 12 months
healthcare costs
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sung Uk Lee, MD, PhD principal investigator
Center for Proton Therapy, National Cancer Center, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blad-Care (sodium hyaluronate 1.6%, 800 mg/50 mL, BioPlus Co., Ltd.) and Normal Saline (NS) in people with Bladder Cancer and Radiation Cystitis, run by National Cancer Center, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eui Hyun Jung, PhD (821046593407, jeh0315@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.