Selenium and Vitamin E in Preventing Cancer Progression and Recurrence in Patients With Early-Stage Bladder Cancer

January 9, 2014 updated by: University of Birmingham

Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial) [TREATMENT]

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of selenium and vitamin E may stop cancer from growing or coming back.

PURPOSE: This randomized phase III trial is studying giving selenium together with vitamin E to see how well it works compared with a placebo in preventing cancer progression and recurrence in patients with early-stage bladder cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • To investigate whether selenium and/or vitamin E (α-tocopherol) supplementation reduces the risk of recurrence and progression.

OUTLINE: This is a multicenter study. Patients are stratified by recurrence risk group (high vs intermediate) and treatment center and randomized to 1 of 4 treatment arms.

  • Arm I: Patients receive oral selenium tablet and oral vitamin E capsule once daily.
  • Arm II: Patients receive oral selenium tablet and oral placebo capsule once daily.
  • Arm III: Patients receive oral placebo tablet and oral vitamin E capsule once daily.
  • Arm IV: Patients receive oral placebo tablet and oral placebo capsule once daily.

In all arms, treatment continues for up to 5 years in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed every 6 months for 5 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

Study Type

Interventional

Enrollment

515

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

  • United Kingdom
    • England
      • Birmingham, England, United Kingdom, B15 2TT
        • Recruiting
        • University of Birmingham
        • Contact:
          • Maurice Zeegers
          • Phone Number: 44 -121- 414- 6721

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histopathologically confirmed non-muscle-invasive transitional cell carcinoma (< pT2)

    • Newly diagnosed disease
  • Able to be randomized within twelve months of diagnostic transurethral resection bladder tumor/biopsy

  • Must meet 1 of the following recurrence risk criteria:

    • Intermediate risk

      • Multiple G1 pTa (> 1)
      • Solitary G1 pTa (≥ 3 cm)
      • G2 pTa
      • G1 pT1
      • G2 pT1 (1 or 2 tumors)

    • High risk

      • G3 pTa
      • G3 pT1
      • Cis
      • Multiple G2 pT1 (3 or more foci)

    • Low risk

      • Solitary G1 pTa < 3 cm

PATIENT CHARACTERISTICS:

  • Not pregnant or breast feeding
  • No HIV infection
  • No condition that, in the opinion of the local investigator, might interfere with the safety of the patient or evaluation of the trial objectives

PRIOR CONCURRENT THERAPY:

  • No concurrent immunosuppressive therapy after organ transplantation
  • No concurrent cyclosporine
  • Those who currently use or have used selenium and/or vitamin E supplements will not be excluded, however, they must agree not to take supplements containing selenium and vitamin E above a pre-specified dosage

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: Prevention
  • Allocation: Randomized
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Recurrence-free interval

Secondary Outcome Measures

Outcome Measure
Overall survival time
Incidence of transitional cell carcinoma outside the bladder
Incidence of all other malignancies clinically diagnosed
Incidence of cardiovascular events
Quality of life as assessed at each follow-up visit by the quality of life instruments EORTC QLQ-C30, QLQ-BLS24 and QLQ-BLM30
Progression-free interval

Collaborators and Investigators

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

Sponsor

University of Birmingham

Investigators

  • Study Chair: Maurice Zeegers, University of Birmingham

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

December 1, 2005

Study Registration Dates

First Submitted

November 2, 2007

First Submitted That Met QC Criteria

November 2, 2007

First Posted (Estimate)

November 4, 2007

Study Record Updates

Last Update Posted (Estimate)

January 10, 2014

Last Update Submitted That Met QC Criteria

January 9, 2014

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000574080
  • CRUK-BCPP-2005-01-TREATMENT
  • ISRCTN13889738
  • EU-20768

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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