Clinical trial NCT00729287: Selenium in Preventing Cancer Recurrence in Patients With Bladder Cancer
Official title: Phase III Randomized Chemoprevention Study of Selenium on the Recurrence of Non-invasive Bladder Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bladder Cancer
Keywords: stage 0 bladder cancer
stage I bladder cancer
transitional cell carcinoma of the bladder
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Agentschap voor Innovatie door Wetenschap en Technologie
First posted: 2008-08-07
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 known whether selenium is more effective than a placebo in preventing cancer recurrence in patients with bladder cancer.

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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Effect of selenium in preventing the recurrence of bladder cancer
timeFrame: 3 years
Secondary outcomes:
measure: Effect of selenium on the progression of bladder cancer, in terms of histological type, number, and size
timeFrame: 3 years
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Department of public Health, KU Leuven
Study officials:
affiliation: Department of public Health, KU Leuven
name: Frank Buntinx, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.