RecruitingPhase 2/3

Radiation Cystitis Treated With Pentosan Polysulfate Sodium Trial

Taiwan72 participantsStarted 2022-04-29

Plain-language 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.

Who can participate

Age range20 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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)

What they're measuring

Rate of complete remission in lower urinary tract symptoms and hematuria

Timeframe: From date of randomization throughout the treatment period up to 5 years

Time to complete remission

Timeframe: From date of randomization to study completion up to 5 years

Time to hematuria recurrence

Timeframe: From date of randomization to study completion up to 5 years

Assessment of quality of life

Timeframe: From date of randomization to study completion up to 5 years

Assessment of symptoms

Timeframe: From date of randomization to study completion up to 5 years

Trial details

NCT IDNCT05245591

SponsorNational Taiwan University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-01

Contact for this trial

Chi-Shin Tseng, MD

+886223123456 clifford1987tcs@gmail.com

View on ClinicalTrials.gov More Radiation Cystitis trials

Who can participate

Age range20 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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)

What they're measuring

Rate of complete remission in lower urinary tract symptoms and hematuria

Timeframe: From date of randomization throughout the treatment period up to 5 years

Time to complete remission

Timeframe: From date of randomization to study completion up to 5 years

Time to hematuria recurrence

Timeframe: From date of randomization to study completion up to 5 years

Assessment of quality of life

Timeframe: From date of randomization to study completion up to 5 years

Assessment of symptoms

Timeframe: From date of randomization to study completion up to 5 years