Selenium and Vitamin E in Preventing Cancer Progression and Recurrence in Patients With Early-Stage Bladder Cancer
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.
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 Design
Allocation: Randomized, Control: Placebo Control, Masking: Double-Blind, Primary Purpose: Prevention
Conditions
Bladder Cancer
Intervention
selenium, vitamin E, chemoprevention
Location
University of Birmingham
Birmingham
England
United Kingdom
B15 2TT
Status
Recruiting
Source
National Cancer Institute (NCI)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00553345
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Selenious Acid
A selenium compound used as a source of SELENIUM, especially for patients that develop selenium deficiency following prolonged PARENTERAL NUTRITION.
Selenium Radioisotopes
Unstable isotopes of selenium that decay or disintegrate emitting radiation. Se atoms with atomic weights 70-73, 75, 79, 81, and 83-85 are radioactive selenium isotopes.
Selenium-binding Proteins
A group of proteins that covalently attach to selenium or SELENIUM-containing compounds.
Vitamin K
A lipid cofactor that is required for normal blood clotting. Several forms of vitamin K have been identified: VITAMIN K 1 (phytomenadione) derived from plants, VITAMIN K 2 (menaquinone) from bacteria, and synthetic naphthoquinone provitamins, VITAMIN K 3 (menadione). Vitamin K 3 provitamins, after being alkylated in vivo, exhibit the antifibrinolytic activity of vitamin K. Green leafy vegetables, liver, cheese, butter, and egg yolk are good sources of vitamin K.
Urinary Bladder Neoplasms
Tumors or cancer of the URINARY BLADDER.
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