Selenium in Preventing Cancer Recurrence in Patients With Bladder Cancer
NCT ID: NCT00729287
Last Updated: 2016-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
276 participants
INTERVENTIONAL
2009-09-30
2015-12-31
Brief Summary
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PURPOSE: This randomized phase III trial is studying selenium to see how well it works compared with a placebo in preventing cancer recurrence in patients with bladder cancer.
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Detailed Description
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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 carcinoma of the bladder at risk for recurrence.
Secondary
* To determine the effect of selenium on the recurrence of bladder cancer, in terms of histological type, number, and size.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral placebo daily in addition to standard care.
* Arm II: Patients receive oral selenium daily in addition to standard care.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm I
Patients receive oral placebo daily in addition to standard care.
placebo
Given orally
Arm II
Patients receive oral selenium daily in addition to standard care.
selenium
Given orally
Interventions
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selenium
Given orally
placebo
Given orally
Eligibility Criteria
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Inclusion Criteria
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
18 Years
100 Years
ALL
No
Sponsors
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Agentschap voor Innovatie door Wetenschap en Technologie
OTHER
KU Leuven
OTHER
Responsible Party
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Maria Goossens
Prof. dr. Frank Buntinx
Principal Investigators
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Frank Buntinx, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of public Health, KU Leuven
Locations
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Department of public Health, KU Leuven
Leuven, , Belgium
Countries
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References
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Goossens ME, Buntinx F, Joniau S, Ackaert K, Ameye F, Billiet I, Braeckman J, Breugelmans A, Darras J, Dilen K, Goeman L, Kellen E, Tombal B, Van Bruwaene S, Van Cleyenbreuge B, Van der Aa F, Vekemans K, Van Poppel H, Zeegers MP. Designing the selenium and bladder cancer trial (SELEBLAT), a phase lll randomized chemoprevention study with selenium on recurrence of bladder cancer in Belgium. BMC Urol. 2012 Mar 21;12:8. doi: 10.1186/1471-2490-12-8.
Other Identifiers
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CDR0000602239
Identifier Type: -
Identifier Source: org_study_id
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