Phase III Randomized Chemoprevention Study of Selenium on the Recurrence of Non-invasive Bladder Cancer
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Bladder Cancer
- Sponsor
- KU Leuven
- Enrollment
- 276
- Locations
- 1
- Primary Endpoint
- Effect of selenium in preventing the recurrence of bladder cancer
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed Description
OBJECTIVES: Primary * 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. Secondary * 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.
Investigators
Maria Goossens
Prof. dr. Frank Buntinx
KU Leuven
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Effect of selenium in preventing the recurrence of bladder cancer
Time Frame: 3 years
Secondary Outcomes
- Effect of selenium on the progression of bladder cancer, in terms of histological type, number, and size(3 years)