Selenium in Preventing Cancer Recurrence in Patients With Bladder Cancer (SELEBLAT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00729287|
Recruitment Status : Completed
First Posted : August 7, 2008
Last Update Posted : May 12, 2016
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of selenium may keep bladder cancer from growing or coming back. It is not yet known whether selenium is more effective than a placebo in preventing cancer recurrence in patients with bladder cancer.
PURPOSE: This randomized phase III trial is studying selenium to see how well it works compared with a placebo in preventing cancer recurrence in patients with bladder cancer.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Dietary Supplement: selenium Other: placebo||Phase 3|
- To determine the effect of selenium, when administered with standard care, in preventing the recurrence of bladder cancer in patients with non-muscle-invasive transitional cell carcinoma of the bladder at risk for recurrence.
- To determine the effect of selenium on the recurrence of bladder cancer, in terms of histological type, number, and size.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral placebo daily in addition to standard care.
- Arm II: Patients receive oral selenium daily in addition to standard care.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||276 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase III Randomized Chemoprevention Study of Selenium on the Recurrence of Non-invasive Bladder Cancer|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Placebo Comparator: Arm I
Patients receive oral placebo daily in addition to standard care.
Experimental: Arm II
Patients receive oral selenium daily in addition to standard care.
Dietary Supplement: selenium
- Effect of selenium in preventing the recurrence of bladder cancer [ Time Frame: 3 years ]
- Effect of selenium on the progression of bladder cancer, in terms of histological type, number, and size [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00729287
|Department of public Health, KU Leuven|
|Leuven, Belgium, B-3000|
|Principal Investigator:||Frank Buntinx, MD, PhD||Department of public Health, KU Leuven|