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

This study has been completed.
Sponsor:
Collaborator:
Agentschap voor Innovatie door Wetenschap en Technologie
Information provided by (Responsible Party):
Maria Goossens, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT00729287
First received: August 6, 2008
Last updated: May 10, 2016
Last verified: May 2016
  Purpose

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.


Condition Intervention Phase
Bladder Cancer
Dietary Supplement: selenium
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III Randomized Chemoprevention Study of Selenium on the Recurrence of Non-invasive Bladder Cancer

Resource links provided by NLM:


Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • Effect of selenium in preventing the recurrence of bladder cancer [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of selenium on the progression of bladder cancer, in terms of histological type, number, and size [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 276
Study Start Date: September 2009
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00729287

Locations
Belgium
Department of public Health, KU Leuven
Leuven, Belgium, B-3000
Sponsors and Collaborators
Katholieke Universiteit Leuven
Agentschap voor Innovatie door Wetenschap en Technologie
Investigators
Principal Investigator: Frank Buntinx, MD, PhD Department of public Health, KU Leuven
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maria Goossens, Prof. dr. Frank Buntinx, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT00729287     History of Changes
Other Study ID Numbers: CDR0000602239 
Study First Received: August 6, 2008
Last Updated: May 10, 2016
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by Katholieke Universiteit Leuven:
stage 0 bladder cancer
stage I bladder cancer
transitional cell carcinoma of the bladder

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Recurrence
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Disease Attributes
Pathologic Processes
Selenium
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on September 29, 2016