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

NCT ID: NCT00553345

Last Updated: 2014-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 515 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31

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.

Conditions

Bladder Cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

selenium

Intervention Type: DRUG

vitamin E

Intervention Type: DRUG

chemoprevention

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Birmingham

OTHER

Sponsor Role: lead

Principal Investigators

Maurice Zeegers

Role: STUDY_CHAIR

University of Birmingham

Locations

University of Birmingham

Birmingham, England, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Facility Contacts

Maurice Zeegers

Role: primary

44 -121- 414- 6721

Other Identifiers

CRUK-BCPP-2005-01-TREATMENT

Identifier Type: -

Identifier Source: secondary_id

ISRCTN13889738

Identifier Type: -

Identifier Source: secondary_id

EU-20768

Identifier Type: -

Identifier Source: secondary_id

CDR0000574080

Identifier Type: -

Identifier Source: org_study_id