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

Phase 3

• Conditions: Bladder Cancer

• Registration Number: NCT00553345
• Lead Sponsor: University of Birmingham

Brief 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.

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2007-11-02
• Study First Submitted QC: 2007-11-02
• Study First Posted: 2007-11-04
• Status Verified: 2010-02
• Last Update Submitted: 2014-01-09
• Last Update Posted: 2014-01-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 515

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence-free interval

Secondary Outcome Measures

Name	Time	Method
Incidence of cardiovascular events
Incidence of transitional cell carcinoma outside the bladder
Incidence of all other malignancies clinically diagnosed
Overall survival time
Quality of life as assessed at each follow-up visit by the quality of life instruments EORTC QLQ-C30, QLQ-BLS24 and QLQ-BLM30
Progression-free interval

Trial Locations

Locations (1)

University of Birmingham; 🇬🇧 Birmingham, England, United Kingdom