Selenium in Preventing Cancer Recurrence in Patients With Bladder Cancer (SELEBLAT)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phase III Randomized Chemoprevention Study of Selenium on the Recurrence of Non-invasive Bladder Cancer|
- Effect of selenium in preventing the recurrence of bladder cancer [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Effect of selenium on the progression of bladder cancer, in terms of histological type, number, and size [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Study Completion Date:||December 2015|
|Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00729287
|Department of public Health, KU Leuven|
|Leuven, Belgium, B-3000|
|Principal Investigator:||Frank Buntinx, MD, PhD||Department of public Health, KU Leuven|