• Recurrence-free interval
  
• 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
  

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 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.

DISEASE CHARACTERISTICS:

Inclusion criteria:

• Enrolled on protocol CRUK-BCPP-2005-01

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

  • Solitary grade 1 pTa 3 cm or larger and all other stage pTa, pT1, or pT carcinoma in situ (cis)
  • Newly diagnosed disease
• Able to be randomized within three 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)

Exclusion criteria:

• Solitary grade 1, pTa < 3 cm or stage pT2 and above

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 apart from the trial medication