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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2010 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: November 2, 2007
Last updated: January 9, 2014
Last verified: February 2010

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 Intervention Phase
Bladder Cancer Drug: selenium Drug: vitamin E Procedure: chemoprevention Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
Official Title: Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial) [TREATMENT]

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Recurrence-free interval

Secondary Outcome Measures:
  • Overall survival time
  • Incidence of transitional cell carcinoma outside the bladder
  • Incidence of all other malignancies clinically diagnosed
  • Incidence of cardiovascular events
  • 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

Estimated Enrollment: 515
Study Start Date: December 2005
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00553345

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
Study Chair: Maurice Zeegers University of Birmingham
  More Information Identifier: NCT00553345     History of Changes
Other Study ID Numbers: CDR0000574080
Study First Received: November 2, 2007
Last Updated: January 9, 2014

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:
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 processed this record on August 22, 2017