Selenium and Vitamin E in Preventing Cancer Progression and Recurrence in Patients With Early-Stage Bladder Cancer
Conditions
Bladder Cancer
Conditions: official terms
Urinary Bladder Neoplasms
Conditions: Keywords
transitional cell carcinoma of the bladder, stage 0 bladder cancer, stage I bladder cancer
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
Intervention
Name: selenium Type: Drug
Name: vitamin E Type: Drug
Name: chemoprevention Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Location
University of Birmingham
Birmingham, England, United Kingdom
Status: Recruiting
Contact: Maurice Zeegers - 44 -121- 414- 6721
Start Date
December 2005
Sponsors
University of Birmingham
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page