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
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
Incidence of transitional cell carcinoma outside the bladder
Incidence of all other malignancies clinically diagnosed

Trial Locations

Locations (1)

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