Carcinoma, Transitional Cell Clinical Trial
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.
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. ;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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