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

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Method</p> <p>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 <url>http://www.seleblat.org.</url> 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.</p> <p>Design</p> <p>The SELEnium and BLAdder cancer Trial (SELEBLAT) is a phase III randomized, placebo-controlled, academic, double-blind superior trial.</p> <p>Discussion</p> <p>This is the first report on a selenium randomized trial in bladder cancer patients.</p> <p>Trial registration</p> <p>ClinicalTrials.gov identifier: <a href="http://www.clinicaltrials.gov/ct2/show/NCT00729287">NCT00729287</a></p

Baroreflex sensitivity is reduced in obese normotensive children and adolescents

Obesity is associated with autonomic nervous system dysfunction. The aim of the study was to evaluate baroreflex sensitivity, an indicator of autonomic nervous function, in 20 obese children and adolescents in comparison with 20 age- and sex-matched nonobese subjects. All subjects were examined in the supine position over a period of 50 min. Systolic blood pressure (SBP) and RR intervals were monitored continuously. Baroreflex sensitivity was assessed by cross-spectral analysis of SBP and RR interval oscillations (BRS index) and SBP and heart rate oscillations (BRSf index) within the low frequency range (0.04-0.15 Hz). Sensitivity was determined in 3 time intervals of 3 min each to evaluate changes during rest. The BRS index was significantly lower in obese children and adolescents than in the nonobese control group (p = 0.002). Significant changes in the BRS index over time (p = 0.004) were found only in nonobese subjects. In contrast, the BRSf index increased over time in both groups (p = 0.01), and no significant between-group difference was detected. In conclusion, obese children and adolescents show decreased resting baroreflex sensitivity with less variation compared with nonobese subjects. The BRS and BRSf indices appear to be only partially correlated.Zuzana Lazarova, Ingrid Tonhajzerova, Zuzana Trunkvalterova, Andrea Brozmanova, Natasa Honzíková, Kamil Javorka, Mathias Baumert, and Michal Javork