Radiation Cystitis Treated With Pentosan Polysulfate Sodium Trial

Launched by NATIONAL TAIWAN UNIVERSITY HOSPITAL · Feb 16, 2022

Keywords

ClinConnect Summary

The Radiation Cystitis Treated With Pentosan Polysulfate Sodium Trial is a study looking at how effective and safe a medication called pentosan polysulfate sodium is for treating radiation cystitis, a condition that can occur after patients receive radiation therapy in the pelvic area. The trial is currently recruiting participants who are at least 20 years old and have experienced symptoms of radiation cystitis for more than six months after their radiation treatment. Eligible patients should also be able to give their consent to participate in the study.

Participants in this trial will be randomly assigned to receive either the medication or a placebo (a sugar pill with no active ingredients). Throughout the study, they can expect to be monitored for their symptoms and any side effects. This trial is important because it may help find a new treatment option for those suffering from radiation cystitis, potentially improving their quality of life. If you or a loved one is dealing with this condition and meets the eligibility criteria, this trial may be a valuable opportunity to consider.

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ALL

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