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

Primary Purpose

Bladder Cancer

Status
Unknown status
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
selenium
vitamin E
chemoprevention
Sponsored by
University of Birmingham
About
Eligibility
Locations
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

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

Sites / Locations

  • University of BirminghamRecruiting

Outcomes

Primary Outcome Measures

Recurrence-free interval

Secondary Outcome Measures

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

Full Information

First Posted
November 2, 2007
Last Updated
January 9, 2014
Sponsor
University of Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT00553345
Brief Title
Selenium and Vitamin E in Preventing Cancer Progression and Recurrence in Patients With Early-Stage Bladder Cancer
Official Title
Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial) [TREATMENT]
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Birmingham

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Masking
Double
Allocation
Randomized
Enrollment
515 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
selenium
Intervention Type
Drug
Intervention Name(s)
vitamin E
Intervention Type
Procedure
Intervention Name(s)
chemoprevention
Primary Outcome Measure Information:
Title
Recurrence-free interval
Secondary Outcome Measure Information:
Title
Overall survival time
Title
Incidence of transitional cell carcinoma outside the bladder
Title
Incidence of all other malignancies clinically diagnosed
Title
Incidence of cardiovascular events
Title
Quality of life as assessed at each follow-up visit by the quality of life instruments EORTC QLQ-C30, QLQ-BLS24 and QLQ-BLM30
Title
Progression-free interval

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maurice Zeegers
Organizational Affiliation
University of Birmingham
Official's Role
Study Chair
Facility Information:
Facility Name
University of Birmingham
City
Birmingham
State/Province
England
ZIP/Postal Code
B15 2TT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maurice Zeegers
Phone
44 -121- 414- 6721

12. IPD Sharing Statement

Learn more about this trial

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

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