NCT07125924Not yet recruiting
Intravesical Hyaluronic Acid (HA) for Preventing Radiation Cystitis on Bladder Cancer
Intravesical Hyaluronic Acid (HA) for Preventing Radiation Cystitis on Bladder Cancer : A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 15 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 54 (estimated)
- First submitted
- 3 Aug 2025
- Start date
- 22 Aug 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- National Cancer Center, Korea
- Diseases
- Bladder cancer
- NCT number
- NCT07125924
What you commit to
- Study type: Interventional
- Planned participants: 54
- From 22 Aug 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- 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
- Pregnant or breastfeeding women, or women of childbearing potential who are unable or unwilling to use adequate contraception during the study period
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Cancer Center - Korea Coordinator of this site? Confirm its status | Goyang-si | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.