Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
BMC Urology
Published in: BMC Urology 1/2012

Open Access 01-12-2012 | Study protocol

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

Authors: Maria E Goossens, Frank Buntinx, Steven Joniau, Koen Ackaert, Filip Ameye, Ignace Billiet, Johan Braeckman, Alex Breugelmans, Jochen Darras, Kurt Dilen, Lieven Goeman, Eliane Kellen, Bertrand Tombal, Siska Van Bruwaene, Ben Van Cleyenbreuge, Frank Van der Aa, Kris Vekemans, Hendrik Van Poppel, Maurice P Zeegers

Published in: BMC Urology | Issue 1/2012

Login to get access

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
Literature
1.
2.
Ferlay J, Shin H, Bray F, Forman D, Mathers C, Parkin D: GLOBOCAN 2008, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 10 [Internet]. Lyon, France: International Agency for Research on Cancer. 2010, [http://​globocan.​iarc.​fr]
3.
Botteman MF, Pashos CL, Redaelli A, Laskin B, Hauser R: The health economics of bladder cancer: a comprehensive review of the published literature. Pharmacoeconomics. 2003, 21: 1315-1330.CrossRefPubMed
4.
Rayman MP, Infante HG, Sargent M: Food-chain selenium and human health: emphasis on intake. Br J Nutr. 2008, 100: 238-253.PubMed
5.
Whanger PD: Selenocompounds in plants and animals and their biological significance. J Am Coll Nutr. 2002, 21: 223-232.CrossRefPubMed
6.
Combs GF, Gray WP: Chemopreventive agents: selenium. Pharmacol Ther. 1998, 79: 179-192. 10.1016/S0163-7258(98)00014-X.CrossRefPubMed
7.
Sanmartin C, Plano D, Palop JA: Selenium compounds and apoptotic modulation: a new perspective in cancer therapy. Mini Rev Med Chem. 2008, 8: 1020-1031. 10.2174/138955708785740625.CrossRefPubMed
8.
Brozmanova J, Manikova D, Vlckova V, Chovanec M: Selenium: a double-edged sword for defense and offence in cancer. Arch Toxicol. 2010, 84: 919-938. 10.1007/s00204-010-0595-8.CrossRefPubMed
9.
Naithani R: Organoselenium compounds in cancer chemoprevention. Mini Rev Med Chem. 2008, 8: 657-668. 10.2174/138955708784567368.CrossRefPubMed
10.
Kellen E, Zeegers M, Buntinx F: Selenium is inversely associated with bladder cancer risk: a report from the Belgian case-control study on bladder cancer. Int J Urol. 2006, 13: 1180-1184. 10.1111/j.1442-2042.2006.01526.x.CrossRefPubMed
11.
Torun M, Aldemir H, Yardim S: Serum selenium levels in various cancer types. Trace Elements and Electrocytes. 1995, 12: 186-190.
12.
Yalcin O, Karatas F, Erulas FA, Ozdemir E: The levels of glutathione peroxidase, vitamin A, E, C and lipid peroxidation in patients with transitional cell carcinoma of the bladder. BJU Int. 2004, 93: 863-866. 10.1111/j.1464-410X.2003.04729.x.CrossRefPubMed
13.
Nomura A, Heilbrun LK, Morris JS, Stemmermann GN: Serum selenium and the risk of cancer, by specific sites: case-control analysis of prospective data. J Natl Cancer Inst. 1987, 79: 103-108.PubMed
14.
Helzlsouer KJ, Comstock GW, Morris JS: Selenium, lycopene, alpha-tocopherol, beta-carotene, retinol, and subsequent bladder cancer. Cancer Res. 1989, 49: 6144-6148.PubMed
15.
Zeegers MP, Goldbohm RA, Bode P, van den Brandt PA: Prediagnostic toenail selenium and risk of bladder cancer. Cancer Epidemiol Biomarkers Prev. 2002, 11: 1292-1297.PubMed
16.
Michaud DS, Hartman TJ, Taylor PR, Pietinen P, Alfthan G, Virtamo J, Albanes D: No Association between toenail selenium levels and bladder cancer risk. Cancer Epidemiol Biomarkers Prev. 2002, 11: 1505-1506.PubMed
17.
Michaud DS, De Vivo I, Morris JS, Giovannucci E: Toenail selenium concentrations and bladder cancer risk in women and men. Br J Cancer. 2005, 93: 804-806. 10.1038/sj.bjc.6602788.CrossRefPubMedPubMedCentral
18.
Dennert G, Zwahlen M, Brinkman M, Vinceti M, Zeegers Maurice PA, Horneber M: Selenium for preventing cancer. Book Selenium for preventing cancer. 2011, City: John Wiley & Sons, Ltd, (Editor ed.^eds.)
19.
Rayman MP: The use of high-selenium yeast to raise selenium status: how does it measure up?. Br J Nutr. 2004, 92: 557-573. 10.1079/BJN20041251.CrossRefPubMed
20.
Duffield-Lillico AJ, Dalkin BL, Reid ME, Turnbull BW, Slate EH, Jacobs ET, Marshall JR, Clark LC: Selenium supplementation, baseline plasma selenium status and incidence of prostate cancer: an analysis of the complete treatment period of the Nutritional Prevention of Cancer Trial. BJU Int. 2003, 91: 608-612. 10.1046/j.1464-410X.2003.04167.x.CrossRefPubMed
21.
Lippman SM, Klein EA, Goodman PJ, Lucia MS, Thompson IM, Ford LG, Parnes HL, Minasian LM, Gaziano JM, Hartline JA, et al: Effect of selenium and vitamin E on risk of prostate cancer and other cancers: the Selenium and Vitamin E Cancer Prevention Trial (SELECT). JAMA. 2009, 301: 39-51. 10.1001/jama.2008.864.CrossRefPubMed
22.
Goossens ME, Buntinx F, Zeegers MP: Re: Selenium and vitamin E: interesting biology and dashed hope. J Natl Cancer Inst. 2009, 101: 1363-1364. 10.1093/jnci/djp272. author reply 1364CrossRefPubMed
23.
Brinkman M, Buntinx F, Muls E, Zeegers MP: Use of selenium in chemoprevention of bladder cancer. Lancet Oncol. 2006, 7: 766-774. 10.1016/S1470-2045(06)70862-2.CrossRefPubMed
24.
Grossman HB, Stenzl A, Moyad MA, Droller MJ: Bladder cancer: Chemoprevention, complementary approaches and budgetary considerations. Scand J Urol Nephrol. 2008, 42: 213-233.CrossRef
25.
Altwein JE: [Primary prevention of bladder cancer. What's new?]. Urologe A. 2007, 46: 616-621. 10.1007/s00120-007-1348-z.CrossRefPubMed
26.
Busby JE, Kamat AM: Chemoprevention for bladder cancer. J Urol. 2006, 176: 1914-1920. 10.1016/j.juro.2006.07.004.CrossRefPubMed
27.
Amaral AF, Cantor KP, Silverman DT, Malats N: Selenium and bladder cancer risk: a meta-analysis. Cancer Epidemiol Biomarkers Prev. 2010, 19: 2407-2415. 10.1158/1055-9965.EPI-10-0544.CrossRefPubMed
28.
Hatfield DL, Gladyshev VN: The Outcome of Selenium and Vitamin E Cancer Prevention Trial (SELECT) reveals the need for better understanding of selenium biology. Mol Interv. 2009, 9: 18-21. 10.1124/mi.9.1.6.CrossRefPubMedPubMedCentral
29.
Larsen EH, Hansen M, Paulin H, Moesgaard S, Reid M, Rayman M: Speciation and bioavailability of selenium in yeast-based intervention agents used in cancer chemoprevention studies. J AOAC Int. 2004, 87: 225-232.PubMed
30.
Oosterlinck W: Guidelines on diagnosis and treatment of superficial bladder cancer. Minerva Urol Nefrol. 2004, 56: 65-72.PubMed
31.
Navarro-Alarcon M, Cabrera-Vique C: Selenium in food and the human body: a review. Sci Total Environ. 2008, 400: 115-141. 10.1016/j.scitotenv.2008.06.024.CrossRefPubMed
32.
MacFarquhar JK, Broussard DL, Melstrom P, Hutchinson R, Wolkin A, Martin C, Burk RF, Dunn JR, Green AL, Hammond R, et al: Acute selenium toxicity associated with a dietary supplement. Arch Intern Med. 2010, 170: 256-261. 10.1001/archinternmed.2009.495.CrossRefPubMedPubMedCentral
33.
Yang G, Zhou R, Yin S, Gu L, Yan B, Liu Y, Li X: Studies of safe maximal daily dietary selenium intake in a seleniferous area in China I. Selenium intake and tissue selenium levels of the inhabitants. J Trace Elem Electrolytes Health Dis. 1989, 3: 77-87.PubMed
34.
Food: and Nutrition Board - USA Institute of Medicine: Dietary References Intakes for Vitamin C, Vitamin E, Selenium and Carotenoids. 2000, Washington: National Academy Press
35.
Malmstrom PU, Sylvester RJ, Crawford DE, Friedrich M, Krege S, Rintala E, Solsona E, Di Stasi SM, Witjes JA: An individual patient data meta-analysis of the long-term outcome of randomised studies comparing intravesical mitomycin C versus bacillus Calmette-Guerin for non-muscle-invasive bladder cancer. Eur Urol. 2009, 56: 247-256. 10.1016/j.eururo.2009.04.038.CrossRefPubMed
36.
37.
Lamm DL, Riggs DR, Shriver JS, Van Gilder PF, Rach JF, DeHaven JI: Megadose vitamins in bladder cancer: a double-blind clinical trial. J Urol. 1994, 151: 21-26.PubMed
38.
Prout GR, Barton BA: 13-cis-retinoic acid in chemoprevention of superficial bladder cancer. The National Bladder Cancer Group. J Cell Biochem Suppl. 1992, 16I: 148-152.CrossRefPubMed
39.
Sabichi AL, Lerner SP, Atkinson EN, Grossman HB, Caraway NP, Dinney CP, Penson DF, Matin S, Kamat A, Pisters LL, et al: Phase III prevention trial of fenretinide in patients with resected non-muscle-invasive bladder cancer. Clin Cancer Res. 2008, 14: 224-229. 10.1158/1078-0432.CCR-07-0733.CrossRefPubMed
40.
Studer UE, Jenzer S, Biedermann C, Chollet D, Kraft R, von Toggenburg H, Vonbank F: Adjuvant treatment with a vitamin A analogue (etretinate) after transurethral resection of superficial bladder tumors. Final analysis of a prospective, randomized multicenter trial in Switzerland. Eur Urol. 1995, 28: 284-290.PubMed
41.
Newling DW, Robinson MR, Smith PH, Byar D, Lockwood R, Stevens I, De Pauw M, Sylvester R: Tryptophan metabolites, pyridoxine (vitamin B6) and their influence on the recurrence rate of superficial bladder cancer. Results of a prospective, randomised phase III study performed by the EORTC GU Group. EORTC Genito-Urinary Tract Cancer Cooperative Group. Eur Urol. 1995, 27: 110-116.PubMed
42.
Byar D, Blackard C: Comparisons of placebo, pyridoxine, and topical thiotepa in preventing recurrence of stage I bladder cancer. Urology. 1977, 10: 556-561. 10.1016/0090-4295(77)90101-7.CrossRefPubMed
43.
Messing E, Kim KM, Sharkey F, Schultz M, Parnes H, Kim D, Saltzstein D, Wilding G: Randomized prospective phase III trial of difluoromethylornithine vs placebo in preventing recurrence of completely resected low risk superficial bladder cancer. J Urol. 2006, 176: 500-504. 10.1016/j.juro.2006.03.061.CrossRefPubMed
44.
Naito S, Koga H, Yamaguchi A, Fujimoto N, Hasui Y, Kuramoto H, Iguchi A, Kinukawa N: Prevention of recurrence with epirubicin and lactobacillus casei after transurethral resection of bladder cancer. J Urol. 2008, 179: 485-490.CrossRefPubMed
45.
Aso Y, Akaza H, Kotake T, Tsukamoto T, Imai K, Naito S: Preventive effect of a Lactobacillus casei preparation on the recurrence of superficial bladder cancer in a double-blind trial. The BLP Study Group. Eur Urol. 1995, 27: 104-109.PubMed
46.
Zeegers MP, Bryan RT, Langford C, Billingham L, Murray P, Deshmukh NS, Hussain S, James N, Wallace DM, Cheng KK: The West Midlands Bladder Cancer Prognosis Programme: rationale and design. BJU Int. 2009, 105: 784-788.CrossRefPubMed
47.
Stratton MS, Reid ME, Schwartzberg G, Minter FE, Monroe BK, Alberts DS, Marshall JR, Ahmann FR: Selenium and inhibition of disease progression in men diagnosed with prostate carcinoma: study design and baseline characteristics of the 'Watchful Waiting' Study. Anticancer Drugs. 2003, 14: 595-600. 10.1097/00001813-200309000-00004.CrossRefPubMed
48.
Stranges S, Marshall JR, Trevisan M, Natarajan R, Donahue RP, Combs GF, Farinaro E, Clark LC, Reid ME: Effects of selenium supplementation on cardiovascular disease incidence and mortality: secondary analyses in a randomized clinical trial. Am J Epidemiol. 2006, 163: 694-699. 10.1093/aje/kwj097.CrossRefPubMed
49.
Stranges S, Marshall JR, Natarajan R, Donahue RP, Trevisan M, Combs GF, Cappuccio FP, Ceriello A, Reid ME: Effects of long-term selenium supplementation on the incidence of type 2 diabetes: a randomized trial. Ann Intern Med. 2007, 147: 217-223.CrossRefPubMed
50.
Algotar AM, Stratton MS, Stratton SP, Hsu CH, Ahmann FR: No effect of selenium supplementation on serum glucose levels in men with prostate cancer. Am J Med. 2010, 123: 765-768. 10.1016/j.amjmed.2010.02.018.CrossRefPubMedPubMedCentral
51.
Laclaustra M, Navas-Acien A, Stranges S, Ordovas JM, Guallar E: Serum selenium concentrations and diabetes in U.S. adults: National Health and Nutrition Examination Survey (NHANES) 2003-2004. Environ Health Perspect. 2009, 117: 1409-1413.CrossRefPubMedPubMedCentral
52.
MacKenzie T, Zens MS, Ferrara A, Schned A, Karagas MR: Diabetes and risk of bladder cancer: evidence from a case-control study in New England. Cancer. 2011, 117: 1552-1556. 10.1002/cncr.25641.CrossRefPubMed
53.
Yang KC, Lee LT, Lee YS, Huang HY, Chen CY, Huang KC: Serum selenium concentration is associated with metabolic factors in the elderly: a cross-sectional study. Nutr Metab (Lond). 2010, 7: 38-10.1186/1743-7075-7-38.CrossRef
54.
Stranges S, Navas-Acien A, Rayman MP, Guallar E: Selenium status and cardiometabolic health: state of the evidence. Nutr Metab Cardiovasc Dis. 2010, 20: 754-760. 10.1016/j.numecd.2010.10.001.CrossRefPubMed
55.
Laclaustra M, Navas-Acien A, Stranges S, Ordovas JM, Guallar E: Serum selenium concentrations and hypertension in the US Population. Circ Cardiovasc Qual Outcomes. 2009, 2: 369-376. 10.1161/CIRCOUTCOMES.108.831552.CrossRefPubMedPubMedCentral
56.
Nawrot TS, Staessen JA, Roels HA, Den Hond E, Thijs L, Fagard RH, Dominiczak AF, Struijker-Boudier HA: Blood pressure and blood selenium: a cross-sectional and longitudinal population study. Eur Heart J. 2007, 28: 628-633.CrossRefPubMed
57.
Rayman MP: Selenoproteins and human health: insights from epidemiological data. Biochim Biophys Acta. 2009, 1790: 1533-1540. 10.1016/j.bbagen.2009.03.014.CrossRefPubMed
58.
Yang GQ, Xia YM: Studies on human dietary requirements and safe range of dietary intakes of selenium in China and their application in the prevention of related endemic diseases. Biomed Environ Sci. 1995, 8: 187-201.PubMed
59.
Kellen E, Zeegers MP, Dirx M, Houterman S, Droste J, Lawrence G, Truyers C, Bruckers L, Molenberghs G, Joniau S, Buntinx F: Occurrence of both bladder and prostate cancer in five cancer registries in Belgium, The Netherlands and the United Kingdom. Eur J Cancer. 2007, 43: 1694-1700. 10.1016/j.ejca.2007.04.011.CrossRefPubMed
60.
Kellen E, Zeegers MP, Joniau S, Buntinx F: Examining the co-occurrence of bladder and prostate cancer: a worthwhile investigation?. Future Oncol. 2007, 3: 515-519. 10.2217/14796694.3.5.515.CrossRefPubMed
Metadata
Title
Designing the selenium and bladder cancer trial (SELEBLAT), a phase lll randomized chemoprevention study with selenium on recurrence of bladder cancer in Belgium
Authors
Maria E Goossens
Frank Buntinx
Steven Joniau
Koen Ackaert
Filip Ameye
Ignace Billiet
Johan Braeckman
Alex Breugelmans
Jochen Darras
Kurt Dilen
Lieven Goeman
Eliane Kellen
Bertrand Tombal
Siska Van Bruwaene
Ben Van Cleyenbreuge
Frank Van der Aa
Kris Vekemans
Hendrik Van Poppel
Maurice P Zeegers
Publication date
01-12-2012
Publisher
BioMed Central
Published in
BMC Urology / Issue 1/2012
Electronic ISSN: 1471-2490
DOI
https://doi.org/10.1186/1471-2490-12-8

Other articles of this Issue 1/2012

BMC Urology 1/2012 Go to the issue

Research article

Dose and aging effect on patients reported treatment benefit switching from the first overactive bladder therapy with tolterodine ER to fesoterodine: post-hoc analysis from an observational and retrospective study

Research article

IL-8 as a urinary biomarker for the detection of bladder cancer

Research article

Stage I seminoma: treatment outcome at King Hussein Cancer Center in Jordan

Research article

Determination of the differential expression of mitochondrial long non-coding RNAs as a noninvasive diagnosis of bladder cancer

Research article

Urinary levels of Hepatocarcinoma-intestine-pancreas/Pancreatitis-associated protein as a diagnostic biomarker in patients with bladder cancer

Research article

Increased expression of MMP-9 and IL-8 are correlated with poor prognosis of Bladder Cancer