Radiation Cystitis
Conditions
Brief summary
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.
Detailed description
RCT-PPS is a phase II/III study evaluating the efficacy, safety, and tolerability of pentosan polysulfate sodium (PPS) versus placebo to patients with radiation cystitis who have received radiation therapy in pelvic region. Approximately 72 patients were planned to be randomized in RCT-PPS trial in a 1:1 ratio to treatment with either PPS or placebo. Patients will receive oral treatment with 16 weeks (PPS 100mg three times a day for 8 weeks and then with PPS 100mg twice daily for another 8 weeks).
Interventions
DRUGPentosan Polysulfate Sodium 100 MG Oral Capsule
Pentosan Polysulfate Sodium 100 mg three times daily (tid) for 0-8 weeks Pentosan Polysulfate Sodium 100 mg twice daily (bid) for 9-16 weeks
DRUGPlacebo
Placebo 100 mg three times daily (tid) for 0-8 weeks Placebo 100 mg twice daily (bid) for 9-16 weeks
Sponsors
TCM Biotech International Corporation
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of symptoms | From date of randomization to study completion up to 5 years | Functional Assessment of Expanded Prostate Cancer Index Composite-26 (EPIC-26) |
| Time to complete remission | From date of randomization to study completion up to 5 years | Time from randomization to complete remission of lower urinary tract syndromes and hematuria |
| Time to hematuria recurrence | From date of randomization to study completion up to 5 years | Time from randomization to recurrence of hematuria |
| Assessment of quality of life | From date of randomization to study completion up to 5 years | Functional Assessment of 36-Item Short Form Survey (SF-36) |
| Rate of complete remission in lower urinary tract symptoms and hematuria | From date of randomization throughout the treatment period up to 5 years | Number of participants without lower urinary tract symptoms and hematuria assessed by ESOU 2019 and CTCAE v5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of invasive procedures | From date of randomization to study completion up to 5 years | Percentage of patients underwent transurethral cauterization of bladder bleeders or transurethral clots evacuation. |
| Number of adverse events | From date of randomization to study completion up to 5 years | Percentage of patients with any adverse event (AE), adverse event (AE) leading to study drug discontinuation, serious adverse event (SAE), and adverse event (AE) related to study drug. |
| Duration of hospitalization | From date of randomization to study completion up to 5 years | Overall days of hospitalization due to radiation cystitis |
Countries
Taiwan
Contacts
Primary ContactChi-Shin Tseng, MD
Outcome results
None listed