Early versus delayed Blad‑Care (hyaluronic acid + chondroitin) during BCG therapy
Optimal Timing of Intravesical GAG Restoration Therapy for BCG-Induced Bladder Toxicity in Patients With Non-Muscle-Invasive Bladder Cancer: A Prospective Randomized Study
NA · BLAD-HYA Group · NCT07495072
This trial will test whether giving Blad‑Care (hyaluronic acid and chondroitin sulfate) early during BCG treatment reduces bladder irritation in adults with non‑muscle‑invasive bladder cancer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | BLAD-HYA Group (other) |
| Locations | 1 site (Seoul, Dongdaemun-gu) |
| Trial ID | NCT07495072 on ClinicalTrials.gov |
What this trial studies
Patients with non‑muscle‑invasive bladder cancer receiving intravesical BCG are randomized to receive intravesical Blad‑Care either early during BCG induction or delayed after induction. Blad‑Care contains hyaluronic acid and chondroitin sulfate intended to restore the bladder glycosaminoglycan (GAG) layer and protect the urothelium. The study prospectively compares bladder irritation symptoms, adverse events, and BCG treatment adherence between the two timing strategies. The multicenter trial at Korean sites seeks to identify whether early administration reduces BCG‑induced cystitis without compromising oncologic therapy.
Who should consider this trial
Good fit: Adults (≥19 years) with histologically confirmed non‑muscle‑invasive bladder cancer who are candidates for intravesical BCG, have a negative urine culture, and can provide written informed consent.
Not a fit: Patients with hypersensitivity to Blad‑Care components, contraindications to BCG, neurogenic bladder or major urinary tract abnormalities, severe renal dysfunction, or other investigator‑determined exclusions are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, early Blad‑Care could reduce BCG‑related urinary pain and urgency, improve quality of life, and help patients complete their BCG treatment.
How similar studies have performed: Previous small studies of GAG‑replacement therapies have shown symptom improvement in chemical cystitis, but evidence for benefit specifically during BCG therapy is limited and the optimal timing is unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged ≥19 years * Histologically confirmed non-muscle-invasive bladder cancer * Candidates for intravesical BCG therapy * Negative urine culture prior to BCG therapy * Ability to provide written informed consent Exclusion Criteria: * Hypersensitivity to components of Blad-Care * Contraindication to BCG therapy * Neurogenic bladder or significant urinary tract abnormalities * Severe renal dysfunction * Any condition considered unsuitable for study participation by the investigator
Where this trial is running
Seoul, Dongdaemun-gu
- Kyung Hee University Hospital — Seoul, Dongdaemun-gu, South Korea (RECRUITING)
Study contacts
- Principal investigator: Chunwoo Lee — Kyung Hee University Hospital
- Study coordinator: Chunwoo Lee, M.D., Ph.D.
- Email: lcw200@hanmail.net
- Phone: +8229588897
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Urinary Bladder Neoplasms, BCG-Induced Cystitis, Hyaluronic Acid, BCG-induced Cystitis, BCG-related Bladder Pain, Non-Muscle Invasive Bladder Cancer, Interstitial Cystitis