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

Primary Purpose

Bladder Cancer

Status
Completed
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
selenium
placebo
Sponsored by
KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring stage 0 bladder cancer, stage I bladder cancer, transitional cell carcinoma of the bladder

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of public Health, KU Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Arm I

Arm II

Arm Description

Patients receive oral placebo daily in addition to standard care.

Patients receive oral selenium daily in addition to standard care.

Outcomes

Primary Outcome Measures

Effect of selenium in preventing the recurrence of bladder cancer

Secondary Outcome Measures

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

Full Information

First Posted
August 6, 2008
Last Updated
May 10, 2016
Sponsor
KU Leuven
Collaborators
Agentschap voor Innovatie door Wetenschap en Technologie
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1. Study Identification

Unique Protocol Identification Number
NCT00729287
Brief Title
Selenium in Preventing Cancer Recurrence in Patients With Bladder Cancer
Acronym
SELEBLAT
Official Title
Phase III Randomized Chemoprevention Study of Selenium on the Recurrence of Non-invasive Bladder Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven
Collaborators
Agentschap voor Innovatie door Wetenschap en Technologie

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
stage 0 bladder cancer, stage I bladder cancer, transitional cell carcinoma of the bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
276 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Placebo Comparator
Arm Description
Patients receive oral placebo daily in addition to standard care.
Arm Title
Arm II
Arm Type
Experimental
Arm Description
Patients receive oral selenium daily in addition to standard care.
Intervention Type
Dietary Supplement
Intervention Name(s)
selenium
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
Given orally
Primary Outcome Measure Information:
Title
Effect of selenium in preventing the recurrence of bladder cancer
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Effect of selenium on the progression of bladder cancer, in terms of histological type, number, and size
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Buntinx, MD, PhD
Organizational Affiliation
Department of public Health, KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of public Health, KU Leuven
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
22436453
Citation
Goossens ME, Buntinx F, Joniau S, Ackaert K, Ameye F, Billiet I, Braeckman J, Breugelmans A, Darras J, Dilen K, Goeman L, Kellen E, Tombal B, Van Bruwaene S, Van Cleyenbreuge B, Van der Aa F, Vekemans K, Van Poppel H, Zeegers MP. Designing the selenium and bladder cancer trial (SELEBLAT), a phase lll randomized chemoprevention study with selenium on recurrence of bladder cancer in Belgium. BMC Urol. 2012 Mar 21;12:8. doi: 10.1186/1471-2490-12-8.
Results Reference
derived

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Selenium in Preventing Cancer Recurrence in Patients With Bladder Cancer

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