Status:
COMPLETED
Selenium in Preventing Cancer Recurrence in Patients With Bladder Cancer
Lead Sponsor:
KU Leuven
Collaborating Sponsors:
Agentschap voor Innovatie door Wetenschap en Technologie
Conditions:
Bladder Cancer
Eligibility:
All Genders
18-100 years
Phase:
PHASE3
Brief Summary
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of selenium may keep bladder cancer from growing or coming back. It is not yet know...
Detailed Description
OBJECTIVES: Primary * To determine the effect of selenium, when administered with standard care, in preventing the recurrence of bladder cancer in patients with non-muscle-invasive transitional cell...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histopathologically confirmed non-muscle-invasive transitional cell carcinoma (TCC) of the bladder (\< pT2 )
- PATIENT CHARACTERISTICS:
- Able to swallow pills
- Not pregnant
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years
- No known hypersensitivity or adverse reactions to selenium
- No other serious medical or psychiatric illness that would preclude giving informed consent
- No condition that, in the opinion of the investigator, may interfere with the safety of the patient or the evaluation of the study objectives
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 30 days since prior daily dietary supplements containing selenium
- No other concurrent selenium (contained in individual supplements, antioxidant mix, or multivitamin) intake
- No concurrent participation in another study involving a medical, surgical, nutritional, or lifestyle intervention
- Concurrent participation in the follow-up phase of another study allowed
Exclusion
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT00729287
Start Date
September 1 2009
End Date
December 1 2015
Last Update
May 12 2016
Active Locations (1)
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1
Department of public Health, KU Leuven
Leuven, Belgium, B-3000