Clinical trial NCT00172367: Chemoprevention Trial for Uremia-Associated Urothelial Carcinoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Carcinoma, Transitional Cell
Keywords: Urothelial carcinoma
Lycopene
uremia
prevention
biomarker
progression
anti-oxidant
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: changes of intermediate biomarker status after lycopene supplementation
Secondary outcomes:
measure: safety and tolerability
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yeong-Shiau Pu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: