Treatment for radiation cystitis using pentosan polysulfate sodium

A Randomized, Controlled, Phase II/III Trial to Evaluate the Efficacy and Safety of U101 Oral Capsules in Radiation-induced Cystitis

This study is testing if a medication called pentosan polysulfate sodium can help people with radiation cystitis feel better after pelvic radiation therapy.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: National Taiwan University Hospital (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Taipei)
• Trial ID: NCT05245591 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of pentosan polysulfate sodium (PPS) compared to a placebo in patients suffering from radiation cystitis following pelvic radiation therapy. It is a randomized controlled trial involving approximately 72 participants who will receive oral PPS for 16 weeks, with a dosage of 100 mg three times a day for the first 8 weeks, followed by 100 mg twice daily for the next 8 weeks. The trial aims to determine whether PPS can alleviate symptoms associated with radiation cystitis.

Who should consider this trial

Good fit: Ideal candidates are adults aged 20 and older who have experienced radiation cystitis at least 6 months after receiving pelvic radiation therapy.

Not a fit: Patients with significant liver, kidney, or coagulation abnormalities, as well as those who are pregnant or breastfeeding, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from radiation cystitis.

How similar studies have performed: While there have been studies on treatments for radiation cystitis, the specific use of pentosan polysulfate sodium in this context is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in the study protocol.
2. Patients must be ≥20 years of age
3. Patients must have received definitive radiation therapy for cancer in pelvic area.
4. Time from the end of radiation therapy to radiation cystitis must be longer than 6 months.
5. Radiation cystitis with lower urinary tract symptoms or hematuria.

Exclusion Criteria:

1. Abnormal liver function with indication of AST, ALT, or total bilirubin ≥ 1.5 times higher than normal
2. Abnormal renal function with serum creatinine ≥ 1.5 times higher than normal
3. Abnormal coagulation profile with PT/INR higher than normal
4. Thrombocytopenia with platelet counts \< 100,000/μL
5. Pregnant or breastfeeding, expecting to pregnancy, or positive for pregnancy test
6. Patients who have systemic inflammatory symptoms during screening period (ie, fever up to 38℃ or WBC counts \>12,000/μL)
7. Patients with known urinary tract infection within 6 months of randomization.
8. Any previous intravesical instillation within 6 months of randomization (ie, hyaluronic acid instillation)
9. Any previous hyperbaric oxygen therapy within 6 months of randomization
10. Any previous treatment with pentosan polysulfate sodium within 6 months of randomization
11. Has history of thrombocytopenia, hemophilia or bladder cancer
12. Has known history of Human Immunodeficiency Virus (HIV) or organ transplantation
13. Has known history of drug allergy to pentosan polysulfate sodium
14. Has hematuria caused by clinically active urolithiasis or urothelial carcinoma

Where this trial is running

Taipei

• National Taiwan University Hospital — Taipei, Taiwan (Recruiting)

Study contacts

• Principal investigator: Chao-Yuan Huang, MD, PhD — National Taiwan University Hospital
• Study coordinator: Chi-Shin Tseng, MD

Conditions Radiation Cystitis