Radiation Cystitis Treated With Pentosan Polysulfate Sodium Trial

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Radiation Cystitis

In brief

The purpose of this study is to evaluate the efficacy and safety of pentosan polysulfate sodium versus placebo and in patients with radiation cystitis who have received radiation therapy in pelvic region.

Key facts

Study ID

NCT05245591

Run by

National Taiwan University Hospital

People needed

72

Starts

2022-04-29

Expected to finish

2029-11-01

Last updated by the study team

2022-05-04

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Patients must be ≥20 years of age
• Patients must have received definitive radiation therapy for cancer in pelvic area.
• Time from the end of radiation therapy to radiation cystitis must be longer than 6 months.
• Radiation cystitis with lower urinary tract symptoms or hematuria.

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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