Designing the selenium and bladder cancer trial (SELEBLAT), a phase lll randomized chemoprevention study with selenium on recurrence of bladder cancer in Belgium

Abstract Background In Belgium, bladder cancer is the fifth most common cancer in males (5.2%) and the sixth most frequent cause of death from cancer in males (3.8%). Previous epidemiological studies have consistently reported that selenium concentrations were inversely associated with the risk of bladder cancer. This suggests that selenium may also be suitable for chemoprevention of recurrence. Method The SELEBLAT study opened in September 2009 and is still recruiting all patients with non-invasive transitional cell carcinoma of the bladder on TURB operation in 15 Belgian hospitals. Recruitme... Mehr ...

Verfasser: Goossens Maria E
Buntinx Frank
Joniau Steven
Ackaert Koen
Ameye Filip
Billiet Ignace
Braeckman Johan
Breugelmans Alex
Darras Jochen
Dilen Kurt
Goeman Lieven
Kellen Eliane
Tombal Bertrand
Van Bruwaene Siska
Van Cleyenbreuge Ben
Van der Aa Frank
Vekemans Kris
Van Poppel Hendrik
Zeegers Maurice P
Dokumenttyp: Artikel
Erscheinungsdatum: 2012
Reihe/Periodikum: BMC Urology, Vol 12, Iss 1, p 8 (2012)
Verlag/Hrsg.: BMC
Schlagwörter: Selenium / Bladder cancer / Transitional Cell Carcinoma / Chemoprevention / Randomized clinical trial / Urology / Diseases of the genitourinary system. Urology / RC870-923
Sprache: Englisch
Permalink: https://search.fid-benelux.de/Record/base-28971339
Datenquelle: BASE; Originalkatalog
Powered By: BASE
Link(s) : https://doi.org/10.1186/1471-2490-12-8

Abstract Background In Belgium, bladder cancer is the fifth most common cancer in males (5.2%) and the sixth most frequent cause of death from cancer in males (3.8%). Previous epidemiological studies have consistently reported that selenium concentrations were inversely associated with the risk of bladder cancer. This suggests that selenium may also be suitable for chemoprevention of recurrence. Method The SELEBLAT study opened in September 2009 and is still recruiting all patients with non-invasive transitional cell carcinoma of the bladder on TURB operation in 15 Belgian hospitals. Recruitment progress can be monitored live at http://www.seleblat.org. Patients are randomly assigned to selenium yeast (200 μg/day) supplementation for 3 years or matching placebo, in addition to standard care. The objective is to determine the effect of selenium on the recurrence of bladder cancer. Randomization is stratified by treatment centre. A computerized algorithm randomly assigns the patients to a treatment arm. All study personnel and participants are blinded to treatment assignment for the duration of the study. Design The SELEnium and BLAdder cancer Trial (SELEBLAT) is a phase III randomized, placebo-controlled, academic, double-blind superior trial. Discussion This is the first report on a selenium randomized trial in bladder cancer patients. Trial registration ClinicalTrials.gov identifier: NCT00729287