Selenium in Preventing Cancer Recurrence in Patients With Bladder Cancer

KU Leuven276 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

276

Conditions

Bladder Cancer

Interventions

seleniumDIETARY_SUPPLEMENT

Given orally

placeboOTHER

Given orally

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of public Health, KU Leuven

Leuven, Belgium

Outcomes

Primary Outcomes

Effect of selenium in preventing the recurrence of bladder cancer

Time frame: 3 years

Secondary Outcomes

Effect of selenium on the progression of bladder cancer, in terms of histological type, number, and size

Time frame: 3 years

Data from ClinicalTrials.gov

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