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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00553345
First received: November 2, 2007
Last updated: January 9, 2014
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Bladder Cancer
Drug: selenium
Drug: vitamin E
Procedure: chemoprevention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial) [TREATMENT]

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

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 [ Designated as safety issue: No ]

Estimated Enrollment: 515
Study Start Date: December 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00553345

Locations
United Kingdom
University of Birmingham Recruiting
Birmingham, England, United Kingdom, B15 2TT
Contact: Maurice Zeegers    44 -121- 414- 6721      
Sponsors and Collaborators
University of Birmingham
Investigators
Study Chair: Maurice Zeegers University of Birmingham
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00553345     History of Changes
Other Study ID Numbers: CDR0000574080, CRUK-BCPP-2005-01-TREATMENT, ISRCTN13889738, EU-20768
Study First Received: November 2, 2007
Last Updated: January 9, 2014
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
transitional cell carcinoma of the bladder
stage 0 bladder cancer
stage I bladder cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Selenium
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Vitamins
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on July 24, 2014