Selenium in Preventing Cancer Recurrence in Patients With Bladder Cancer

Phase 3

Completed

• Conditions: Bladder Cancer
• Interventions: Other: placebo; Dietary Supplement: selenium

• Registration Number: NCT00729287
• Lead Sponsor: KU Leuven

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2008-08-06
• Study First Submitted QC: 2008-08-06
• Study First Posted: 2008-08-07
• Study Start: 2009-09
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 276

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I	placebo	Patients receive oral placebo daily in addition to standard care.
Arm II	selenium	Patients receive oral selenium daily in addition to standard care.

Primary Outcome Measures

Name	Time	Method
Effect of selenium in preventing the recurrence of bladder cancer	3 years

Secondary Outcome Measures

Name	Time	Method
Effect of selenium on the progression of bladder cancer, in terms of histological type, number, and size	3 years

Trial Locations

Locations (1)

Department of public Health, KU Leuven; 🇧🇪 Leuven, Belgium