Chemoprevention Trial for Uremia-Associated Urothelial Carcinoma

NCT00172367 | Withdrawn Phase 2

• 1 other identifier: 930906
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Transitional Cell

Keywords

Urothelial carcinoma; Lycopene; uremia; prevention; biomarker; progression; anti-oxidant

Outcome Measures

Primary Outcomes (1)

• changes of intermediate biomarker status after lycopene supplementation

Secondary Outcomes (1)

• safety and tolerability

Interventions

Lycopene DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Transitional Cell; Uremia; Disease Progression

Interventions

Lycopene

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Yeong-Shiau Pu, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: January 1, 2006
• Last Updated: September 26, 2008

Record last verified: 2004-11

Locations

TW (1)