Actively Recruiting
Radiation Cystitis Treated With Pentosan Polysulfate Sodium Trial
Led by National Taiwan University Hospital · Updated on 2022-05-04
72
Participants Needed
1
Research Sites
391 weeks
Total Duration
On this page
Sponsors
N
National Taiwan University Hospital
Lead Sponsor
T
TCM Biotech International Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Radiation Cystitis Treated With Pentosan Polysulfate Sodium Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give signed informed consent and follow study requirements
- 20 years of age or older
- Have received definitive radiation therapy for cancer in the pelvic area
- More than 6 months have passed since the end of radiation therapy
- Have radiation cystitis with lower urinary tract symptoms or hematuria
You will not qualify if you...
- Abnormal liver function with AST, ALT, or total bilirubin 1.5 times higher than normal
- Abnormal kidney function with serum creatinine 1.5 times higher than normal
- Abnormal blood clotting with PT/INR higher than normal
- Low platelet count under 100,000/µL
- Pregnant, breastfeeding, trying to become pregnant, or positive pregnancy test
- Having fever up to 38°C or high white blood cell count during screening
- Known urinary tract infection within 6 months before randomization
- Previous intravesical instillation treatment within 6 months before randomization
- Previous hyperbaric oxygen therapy within 6 months before randomization
- Previous treatment with pentosan polysulfate sodium within 6 months before randomization
- History of thrombocytopenia, hemophilia, or bladder cancer
- Known history of HIV or organ transplantation
- Known allergy to pentosan polysulfate sodium
- Hematuria caused by active urolithiasis or urothelial carcinoma
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital
Taipei, Taiwan
Actively Recruiting
Research Team
C
Chi-Shin Tseng, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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