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

University of Birmingham

Status and phase: Unknown; Phase 3

Conditions: Bladder Cancer

Treatments: Procedure: chemoprevention; Drug: selenium; Drug: vitamin E

Study type: Interventional

Funder types: Other

Identifiers

NCT00553345

EU-20768

ISRCTN13889738

CRUK-BCPP-2005-01-TREATMENT

CDR0000574080

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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