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

May 10, 2016 updated by: Maria Goossens, KU Leuven

Phase III Randomized Chemoprevention Study of Selenium on the Recurrence of Non-invasive Bladder Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

276

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, B-3000
        • Department of public Health, KU Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Arm I
Patients receive oral placebo daily in addition to standard care.
Other: placebo
Given orally
EXPERIMENTAL: Arm II
Patients receive oral selenium daily in addition to standard care.
Dietary supplement: selenium
Given orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect of selenium in preventing the recurrence of bladder cancer
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Effect of selenium on the progression of bladder cancer, in terms of histological type, number, and size
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Collaborators

Agentschap voor Innovatie door Wetenschap en Technologie

Investigators

  • Principal Investigator: Frank Buntinx, MD, PhD, Department of public Health, KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

August 6, 2008

First Submitted That Met QC Criteria

August 6, 2008

First Posted (ESTIMATE)

August 7, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

May 12, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000602239

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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