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
Recruitment status was Recruiting
Sponsor:
University of Birmingham
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00553345
First received: November 2, 2007
Last updated: February 12, 2010
Last verified: February 2010
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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:
Genetics Home Reference related topics:
bladder cancer
Drug Information available for:
alpha-Tocopherol
Tocopherol
Selenomethionine
Vitamin E succinate
Tocopherol acetate
dl-alpha-Tocopherol
U.S. FDA Resources
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 |
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
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: | February 12, 2010 |
| 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 May 16, 2013