Selenium in Preventing Cancer Recurrence in Patients With Bladder Cancer (SELEBLAT)

Catholic University (KU) of Leuven

Status and phase

Completed

Phase 3

Conditions

Bladder Cancer

Treatments

Other: placebo

Dietary Supplement: selenium

Study type

Interventional

Funder types

Other

Identifiers

NCT00729287

CDR0000602239

Details and patient eligibility

About

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of selenium may keep bladder cancer from growing or coming back. It is not yet known whether selenium is more effective than a placebo in preventing cancer recurrence in patients with bladder cancer.

PURPOSE: This randomized phase III trial is studying selenium to see how well it works compared with a placebo in preventing cancer recurrence in patients with bladder cancer.

Full description

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.

Enrollment

276 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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