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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00553345
Recruitment Status : Unknown
Verified February 2010 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : November 5, 2007
Last Update Posted : January 10, 2014
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Drug: selenium Drug: vitamin E Procedure: chemoprevention Phase 3

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 515 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
Official Title: Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial) [TREATMENT]
Study Start Date : December 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin E

Primary Outcome Measures :
  1. Recurrence-free interval

Secondary Outcome Measures :
  1. Overall survival time
  2. Incidence of transitional cell carcinoma outside the bladder
  3. Incidence of all other malignancies clinically diagnosed
  4. Incidence of cardiovascular events
  5. Quality of life as assessed at each follow-up visit by the quality of life instruments EORTC QLQ-C30, QLQ-BLS24 and QLQ-BLM30
  6. Progression-free interval

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histopathologically confirmed non-muscle-invasive transitional cell carcinoma (< pT2)

    • Newly diagnosed disease
  • Able to be randomized within twelve months of diagnostic transurethral resection bladder tumor/biopsy
  • Must meet 1 of the following recurrence risk criteria:

    • Intermediate risk

      • Multiple G1 pTa (> 1)
      • Solitary G1 pTa (≥ 3 cm)
      • G2 pTa
      • G1 pT1
      • G2 pT1 (1 or 2 tumors)
    • High risk

      • G3 pTa
      • G3 pT1
      • Cis
      • Multiple G2 pT1 (3 or more foci)
    • Low risk

      • Solitary G1 pTa < 3 cm


  • Not pregnant or breast feeding
  • No HIV infection
  • No condition that, in the opinion of the local investigator, might interfere with the safety of the patient or evaluation of the trial objectives


  • No concurrent immunosuppressive therapy after organ transplantation
  • No concurrent cyclosporine
  • Those who currently use or have used selenium and/or vitamin E supplements will not be excluded, however, they must agree not to take supplements containing selenium and vitamin E above a pre-specified dosage

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00553345

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United Kingdom
University of Birmingham Recruiting
Birmingham, England, United Kingdom, B15 2TT
Contact: Maurice Zeegers    44 -121- 414- 6721      
Sponsors and Collaborators
University of Birmingham
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Study Chair: Maurice Zeegers University of Birmingham

Layout table for additonal information Identifier: NCT00553345     History of Changes
Other Study ID Numbers: CDR0000574080
First Posted: November 5, 2007    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: February 2010
Keywords provided by National Cancer Institute (NCI):
transitional cell carcinoma of the bladder
stage 0 bladder cancer
stage I bladder cancer
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Vitamin E
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents
Trace Elements