Clinical Trial: Chemoprevention Trial for Uremia-Associated Urothelial Carcinoma

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title:

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 Summary: 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.
Sponsor: National Taiwan University Hospital

Current Primary Outcome: changes of intermediate biomarker status after lycopene supplementation

Original Primary Outcome: Same as current

Current Secondary Outcome: safety and tolerability

Original Secondary Outcome: Same as current

Information By: National Taiwan University Hospital

Dates:
Date Received: September 12, 2005
Date Started: January 2006
Date Completion:
Last Updated: September 25, 2008
Last Verified: November 2004