NCT00729287

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
276

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2009

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2008

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

6.3 years

First QC Date

August 6, 2008

Last Update Submit

May 10, 2016

Conditions

Bladder Cancer

Keywords

stage 0 bladder cancerstage I bladder cancertransitional cell carcinoma of the bladder

Outcome Measures

Primary Outcomes (1)

  • Effect of selenium in preventing the recurrence of bladder cancer

    3 years

Secondary Outcomes (1)

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

    3 years

Study Arms (2)

Arm I

PLACEBO COMPARATOR

Patients receive oral placebo daily in addition to standard care.

Other: placebo

Arm II

EXPERIMENTAL

Patients receive oral selenium daily in addition to standard care.

Dietary Supplement: selenium

Interventions

seleniumDIETARY_SUPPLEMENT

Given orally

Arm II
placeboOTHER

Given orally

Arm I

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Department of public Health, KU Leuven

Leuven, B-3000, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 22436453DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Selenium

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsMinerals

Study Officials

  • Frank Buntinx, MD, PhD

    Department of public Health, KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr. Frank Buntinx

Study Record Dates

First Submitted

August 6, 2008

First Posted

August 7, 2008

Study Start

September 1, 2009

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations

BE(1)