Trials / Withdrawn
WithdrawnNCT00172367
Chemoprevention Trial for Uremia-Associated Urothelial Carcinoma
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- National Taiwan University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lycopene |
Timeline
- Start date
- 2006-01-01
- First posted
- 2005-09-15
- Last updated
- 2008-09-26
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT00172367. Inclusion in this directory is not an endorsement.