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Chemoprevention Trial for Uremia-Associated Urothelial Carcinoma

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ClinicalTrials.gov Identifier: NCT00172367
Recruitment Status : Withdrawn (This study was for National Science Council project. The study was not funded, so the study was withdrawn.)
First Posted : September 15, 2005
Last Update Posted : September 26, 2008
Sponsor:
Information provided by:
National Taiwan University Hospital

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.


Condition or disease Intervention/treatment Phase
Carcinoma, Transitional Cell Drug: Lycopene Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : January 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Lycopene




Primary Outcome Measures :
  1. changes of intermediate biomarker status after lycopene supplementation

Secondary Outcome Measures :
  1. safety and tolerability


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00172367


Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Yeong-Shiau Pu, MD, PhD National Taiwan University Hospital

ClinicalTrials.gov Identifier: NCT00172367     History of Changes
Other Study ID Numbers: 930906
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: September 26, 2008
Last Verified: November 2004

Keywords provided by National Taiwan University Hospital:
Urothelial carcinoma
Lycopene
uremia
prevention
biomarker
progression
anti-oxidant

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Lycopene
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents