NCT00729287

Selenium in Preventing Cancer Recurrence in Patients With Bladder Cancer

Phase III Randomized Chemoprevention Study of Selenium on the Recurrence of Non-invasive Bladder Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 276 (actual)
• Sponsor: KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	selenium	Given orally
OTHER	placebo	Given orally

Timeline

• Start date: 2009-09-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2008-08-07
• Last updated: 2016-05-12

Locations

1 site across 1 country: Belgium