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

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ClinicalTrials.gov 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
Sponsor:
Information provided by:

November 2, 2007
November 5, 2007
January 10, 2014
December 2005
Not Provided
Recurrence-free interval
  • Recurrence-free interval
  • Progression-free interval
Complete list of historical versions of study NCT00553345 on ClinicalTrials.gov Archive Site
  • 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
  • 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
Not Provided
Not Provided
 
Selenium and Vitamin E in Preventing Cancer Progression and Recurrence in Patients With Early-Stage Bladder Cancer
Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial) [TREATMENT]

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.

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.

Interventional
Phase 3
Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
Bladder Cancer
  • Drug: selenium
  • Drug: vitamin E
  • Procedure: chemoprevention
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
515
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DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00553345
CDR0000574080
CRUK-BCPP-2005-01-TREATMENT
ISRCTN13889738
EU-20768
Not Provided
Not Provided
Not Provided
Not Provided
University of Birmingham
Not Provided
Study Chair: Maurice Zeegers University of Birmingham
National Cancer Institute (NCI)
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP