Chemoprevention Trial for Uremia-Associated Urothelial Carcinoma

Study Overview
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Brief Summary
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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
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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
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Carcinoma, Transitional Cell

Intervention / Treatment
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* Drug: Lycopene


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients have pathologically-proven urothelial carcinoma (UC) with a clinical stage <= T3N0M0 Patients have no visible or identifiable residual UC after treatment with a life expectancy of > 6 months Patients have remaining urothelium at risk of recurrence (transplanted renal unit excluded) No other active malignancy. Patients who have other primary malignancies should be treated successfully prior to the study entry and should be in a cure or remission state for at least one year. Patients are able to take lycopene capsules orally. Patients who sign and give informed consents and are willing to conform to the scheduled sampling of the blood, urine and/or tissue Exclusion Criteria: Patients who have clinical stage > T3N0M0 or metastatic disease Positive urine cytology. Patients who have positive cytology should be subjected to a serial diagnostic workup which may include renal echo, cystoscopy and ureterorenoscopy, and image studies (intravenous urography, computed tomography, magnetic resonance urography, retrograde or antegrade pyelography). If no recurrent or residual tumors are found, patients are still eligible for the study. Patients who have ever received systemic chemotherapy within 12 months Patients who have gastrointestinal malabsorption regardless of the etiology Have known allergic reaction to tomato or lycopene Patients who are participating or will participate in other clinical trials Patients who have active urinary tract infection can not be accrued until infection is effectively controlled Patient's age is less than 18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lycopene|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of intermediate biomarker status after lycopene supplementation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and tolerability |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urothelial carcinoma, Lycopene, uremia, prevention, biomarker, progression, anti-oxidant