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

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. webcite 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.The SELEnium and BLAdder cancer Trial (SELEBLAT) is a phase III randomized, placebo-controlled, academic, double-blind superior trial.This is the first report on a selenium randomized trial in bladder cancer patients.ClinicalTrials.gov identifier: NCT00729287In Belgium, 2159 patients were newly diagnosed with a primary bladder cancer in 2008. These numbers have been stable over the last five years. The incidence and mortality rates increase sharply with age and about two-thirds of patients are ≥ 65 years old. The mean age of diagnosis is 73 years for men and 74 years for women. In the age group 45-59 years, the male/female ratio is 3:3, while in the age group 60-74 years the incidence rates in males are more than fivefold than the rates in females. The relative 5-year survival is 47% for men and 54% for women [1]. Almost 400,000 bladder cancer cases occurred worldwide in 2008 [2]. Moreover, in the USA and probably in most Western countries, bladder cancer is the most expensive cancer in terms of healthcare expenditure [3] because of lifetime ongoing cystoscopies. Any reduction in the need for cystoscopies reduces the cost and even more important, improves quality of life.Evidence supporting the use of selenium as a general cancer preventive agent includes pr