Spots Global Cancer Trial Database for Chemoprevention Trial for Uremia-Associated Urothelial Carcinoma

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Trial Identification

Brief Title: Chemoprevention Trial for Uremia-Associated Urothelial Carcinoma

Official Title:

Study ID: NCT00172367

Conditions

Carcinoma, Transitional Cell

Interventions

Lycopene

Study Description

Brief Summary: 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.

Detailed Description: 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.