Selenium in Preventing Cancer Recurrence in Patients With Bladder Cancer

OBJECTIVES:

Primary

• To determine the effect of selenium, when administered with standard care, in preventing the recurrence of bladder cancer in patients with non-muscle-invasive transitional cell carcinoma of the bladder at risk for recurrence.

Secondary

• To determine the effect of selenium on the recurrence of bladder cancer, in terms of histological type, number, and size.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral placebo daily in addition to standard care.
• Arm II: Patients receive oral selenium daily in addition to standard care.

DISEASE CHARACTERISTICS:

Histopathologically confirmed non-muscle-invasive transitional cell carcinoma (TCC) of the bladder (< pT2 )

PATIENT CHARACTERISTICS:

• Able to swallow pills
• Not pregnant
• Fertile patients must use effective contraception
• No other malignancy within the past 5 years
• No known hypersensitivity or adverse reactions to selenium
• No other serious medical or psychiatric illness that would preclude giving informed consent
• No condition that, in the opinion of the investigator, may interfere with the safety of the patient or the evaluation of the study objectives

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• More than 30 days since prior daily dietary supplements containing selenium
• No other concurrent selenium (contained in individual supplements, antioxidant mix, or multivitamin) intake
• No concurrent participation in another study involving a medical, surgical, nutritional, or lifestyle intervention

• Concurrent participation in the follow-up phase of another study allowed