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Sponsored by: |
National Taiwan University Hospital |
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Information provided by: | National Taiwan University Hospital |
ClinicalTrials.gov Identifier: | NCT00172367 |
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.
Condition | Intervention | Phase |
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Carcinoma, Transitional Cell |
Drug: Lycopene |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 80 |
Study Start Date: | January 2006 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Taiwan | |
National Taiwan University Hospital | |
Taipei, Taiwan |
Principal Investigator: | Yeong-Shiau Pu, MD, PhD | National Taiwan University Hospital |
Study ID Numbers: | 930906 |
Study First Received: | September 12, 2005 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00172367 History of Changes |
Health Authority: | Taiwan: Department of Health |
Urothelial carcinoma Lycopene uremia prevention |
biomarker progression anti-oxidant |
Anticarcinogenic Agents Radiation-Protective Agents Antioxidants Lycopene Uremia |
Disease Progression Carcinoma, Transitional Cell Transitional Cell Carcinoma Neoplasms, Glandular and Epithelial Carcinoma |
Anticarcinogenic Agents Radiation-Protective Agents Neoplasms by Histologic Type Antioxidants Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Lycopene Physiological Effects of Drugs |
Carcinoma, Transitional Cell Protective Agents Pharmacologic Actions Carcinoma Neoplasms Therapeutic Uses Neoplasms, Glandular and Epithelial |