Radiation Cystitis Treated With Pentosan Polysulfate Sodium Trial
ConditionRadiation Cystitis
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age20+
SponsorNational Taiwan University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Pentosan Polysulfate Sodium 100 MG Oral Capsule
DrugPentosan Polysulfate Sodium 100 mg three times daily (tid) for 0-8 weeks Pentosan Polysulfate Sodium 100 mg twice daily (bid) for 9-16 weeks
Placebo
DrugPlacebo 100 mg three times daily (tid) for 0-8 weeks Placebo 100 mg twice daily (bid) for 9-16 weeks
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Pentosan Polysulfate SodiumExperimental treatment 1 intervention
Group B: Placebo ControlPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Rate of complete remission in lower urinary tract symptoms and hematuria
Number of participants without lower urinary tract symptoms and hematuria assessed by ESOU 2019 and CTCAE v5.0
Time frame
From date of randomization throughout the treatment period up to 5 years2
Time to complete remission
Time from randomization to complete remission of lower urinary tract syndromes and hematuria
Time frame
From date of randomization to study completion up to 5 years3
Time to hematuria recurrence
Time from randomization to recurrence of hematuria
Time frame
From date of randomization to study completion up to 5 years4
Assessment of quality of life
Functional Assessment of 36-Item Short Form Survey (SF-36)
Time frame
From date of randomization to study completion up to 5 yearsSecondary outcomes
1
Duration of hospitalization
Overall days of hospitalization due to radiation cystitis
Time frame
From date of randomization to study completion up to 5 years2
Number of invasive procedures
Percentage of patients underwent transurethral cauterization of bladder bleeders or transurethral clots evacuation.
Time frame
From date of randomization to study completion up to 5 years3
Number of adverse events
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.
Time frame
From date of randomization to study completion up to 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
National Taiwan University Hospital
Lead sponsor
TCM Biotech International Corporation
Collaborator
Source ClinicalTrials.gov