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

NCT00553345 | Unknown Phase 3

• 4 other identifiers: CDR0000574080CRUK-BCPP-2005-01-TREATMENTISRCTN13889738EU-20768
• Study Type: interventional
• Target: 515
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Keywords

transitional cell carcinoma of the bladder; stage 0 bladder cancer; stage I bladder cancer

Outcome Measures

Primary Outcomes (1)

• Recurrence-free interval

Secondary Outcomes (6)

• 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

Interventions

selenium DRUG

vitamin E DRUG

chemoprevention PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Birmingham: lead

Study Sites (1)

University of Birmingham

Birmingham, England, B15 2TT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Selenium; Vitamin E; Chemoprevention

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Minerals; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Drug Therapy; Therapeutics

Study Officials

• Maurice Zeegers

  University of Birmingham

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 2, 2007
• First Posted: November 5, 2007
• Study Start: December 1, 2005
• Last Updated: January 10, 2014

Record last verified: 2010-02

Locations

GB (1)