NCT00553345

Selenium and Vitamin E in Preventing Cancer Progression and Recurrence in Patients With Early-Stage Bladder Cancer

Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial) [TREATMENT]

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 515 (planned)
• Sponsor: University of Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of selenium and vitamin E may stop cancer from growing or coming back. PURPOSE: This randomized phase III trial is studying giving selenium together with vitamin E to see how well it works compared with a placebo in preventing cancer progression and recurrence in patients with early-stage bladder cancer.

Detailed description

OBJECTIVES: * To investigate whether selenium and/or vitamin E (α-tocopherol) supplementation reduces the risk of recurrence and progression. OUTLINE: This is a multicenter study. Patients are stratified by recurrence risk group (high vs intermediate) and treatment center and randomized to 1 of 4 treatment arms. * Arm I: Patients receive oral selenium tablet and oral vitamin E capsule once daily. * Arm II: Patients receive oral selenium tablet and oral placebo capsule once daily. * Arm III: Patients receive oral placebo tablet and oral vitamin E capsule once daily. * Arm IV: Patients receive oral placebo tablet and oral placebo capsule once daily. In all arms, treatment continues for up to 5 years in the absence of disease progression or unacceptable toxicity. Quality of life is assessed every 6 months for 5 years. Peer Reviewed and Funded or Endorsed by Cancer Research UK.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DRUG	selenium
DRUG	vitamin E
PROCEDURE	chemoprevention

Timeline

• Start date: 2005-12-01
• First posted: 2007-11-05
• Last updated: 2014-01-10

Locations

1 site across 1 country: United Kingdom