Chemoprevention Trial for Uremia-Associated Urothelial Carcinoma
Primary Objective: To study if lycopene can improve the biomarker status of urothelial cells in patients with uremia-associated urothelial carcinoma.
Secondary Objective: To evaluate the general safety and tolerability of oral lycopene 30 mg per day for 12 weeks in uremic patients.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
- changes of intermediate biomarker status after lycopene supplementation
- safety and tolerability
|Study Start Date:||January 2006|
This is a renal function-stratified phase II chemoprevention trial. After 8 weeks of a run-in and washout period, participants will take lycopene, 30 mg per day for 12 weeks. The expression of intermediate biomarkers will be determined upon study entry after 8 weeks of run-in/washout, and after 6 and 12 weeks of lycopene supplementation. It takes at least 20 weeks to complete the course.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00172367
|National Taiwan University Hospital|
|Principal Investigator:||Yeong-Shiau Pu, MD, PhD||National Taiwan University Hospital|