Phase III randomised chemoprevention study with selenium on the recurrence of non-invasive urothelial carcinoma. The SELEnium and BLAdder cancer Trial.
In Belgium, bladder cancer (BC) is the fifth most common cancer in men. The per-patient lifetime cost is high. Previous epidemiological studies have consistently reported that selenium concentrations were inversely associated with the risk of BC. We therefore hypothesised that selenium may be suitable for chemoprevention of recurrence of BC.



The Selenium and Bladder Cancer Trial (SELEBLAT) was an academic phase III placebo-controlled, double-blind, randomised clinical trial designed to determine the effect of selenium on recurrence of non-invasive urothelial carcinoma conducted in 14 Belgian hospitals. Patients were randomly assigned by a computer program to oral selenium yeast 200 μg once a day or placebo for three years, in addition to standard care. All study personnel and participants were blinded to treatment assignment for the duration of the study. All randomised patients were included in the intention to treat (ITT) and safety analyses. Per protocol analyses (PPAs) included all patients in the study three months after start date.



Between September 18, 2009 and April 18, 2013, 151 and 141 patients were randomised in the selenium and placebo group. Patients were followed until December 31, 2015. The ITT analysis resulted in 43 (28%; 95% CI, 0.21-0.35) and 45 (32%; 95% CI, 0.24-0.40) recurrences in the selenium and placebo group. The hazard ratio (HR) was 0.85 (95% CI, 0.56-1.29; p = 0.44) while the HR for the PPA resulted in 42 and 39 (28%; 95% CI, 0.20-0.35) recurrences in the selenium and placebo group (HR = 0.96 [95% CI, 0.62-1.48]; p = 0.93).



Selenium supplementation does not lower the probability of recurrence in BC patients.
Department of General Practice, University of Leuven, ACHG-KU Leuven, Kapucijnenvoer 33, Blok J, Bus 7001, 3000, Leuven, Belgium. Electronic address: Mieke.Goossens@kuleuven.be.
Maria E
ME
Goossens
University of Maastricht, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht, The Netherlands; CAPHRI School for Public Health and Primary Care, University of Maastricht, The Netherlands; School of Cancer Sciences, University of Birmingham, Birmingham, UK.
Maurice P
MP
Zeegers
Department of Urology, UZ Leuven, Leuven, Belgium.
Hendrik
H
van Poppel
Department of Urology, UZ Leuven, Leuven, Belgium.
Steven
S
Joniau
Department of Urology, Sint-Elisabethziekenhuis, Turnhout, Belgium.
Koen
K
Ackaert
Department of Urology, AZ Maria Middelares, Gent, Belgium.
Filip
F
Ameye
Department of Urology, AZ Groeninge, Kortrijk, Belgium.
Ignace
I
Billiet
Department of Urology, UZ Brussel, Brussel, Belgium.
Johan
J
Braeckman
Department of Urology, Heilig Hart ziekenhuis, Leuven, Belgium.
Alex
A
Breugelmans
Department of Urology, AZ Damiaan, Oostende, Belgium.
Jochen
J
Darras
Department of Urology, Jessa ziekenhuis, Hasselt, Belgium.
Kurt
K
Dilen
Department of Urology, Heilig Hartziekenhuis, Roeselaere, Belgium.
Lieven
L
Goeman
Department of Urology, Cliniques universitaires Saint-Luc, Brussel, Belgium.
Bertrand
B
Tombal
Department of Urology, AZ Groeninge, Kortrijk, Belgium.
Siska
S
Van Bruwaene
Department of Urology, UZ Leuven, Leuven, Belgium.
Ben
B
Van Cleyenbreugel
Department of Urology, UZ Leuven, Leuven, Belgium.
Frank
F
Van der Aa
Department of Urology, Jessa ziekenhuis, Hasselt, Belgium.
Kris
K
Vekemans
Department of General Practice, University of Leuven, ACHG-KU Leuven, Kapucijnenvoer 33, Blok J, Bus 7001, 3000, Leuven, Belgium; CAPHRI School for Public Health and Primary Care, University of Maastricht, The Netherlands.
Frank
F
Buntinx
D000368:Aged; D000369:Aged, 80 and over; D000975:Antioxidants / Q000627:therapeutic use*; D001530:Belgium; D002278:Carcinoma in Situ / Q000188:drug therapy* / Q000473:pathology; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000473:pathology; D018890:Chemoprevention; D017024:Chemotherapy, Adjuvant; D018572:Disease-Free Survival; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D060046:Maintenance Chemotherapy; D008297:Male; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control*; D009367:Neoplasm Staging; D016016:Proportional Hazards Models; D012643:Selenium / Q000627:therapeutic use*; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000473:pathology; D013520:Urologic Surgical Procedures
D000975:Antioxidants; D012643:Selenium
Bladder cancer; Chemoprevention; Non-invasive urothelial carcinoma; Randomised clinical trial; Selenium; Transitional cell carcinoma; Urology