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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00553345
• Other study ID #: CDR0000574080
• Secondary ID: CRUK-BCPP-2005-0
• Status: Recruiting
• Phase: Phase 3
• First received: November 2, 2007
• Last updated: January 9, 2014
• Start date: December 2005

Study information

• Verified date: February 2010
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 515
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• selenium

• vitamin E

Procedure:
• chemoprevention

Locations

Country	Name	City	State
United Kingdom	University of Birmingham	Birmingham	England

Sponsors (1)

Lead Sponsor	Collaborator
University of Birmingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence-free interval
Secondary	Overall survival time
Secondary	Incidence of transitional cell carcinoma outside the bladder
Secondary	Incidence of all other malignancies clinically diagnosed
Secondary	Incidence of cardiovascular events
Secondary	Quality of life as assessed at each follow-up visit by the quality of life instruments EORTC QLQ-C30, QLQ-BLS24 and QLQ-BLM30
Secondary	Progression-free interval			No