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.
Interventional
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
Yeong-Shiau Pu, MD, PhD
Principal Investigator
National Taiwan University Hospital
Taiwan: Department of Health
930906
NCT00172367
January 2006
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