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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Birmingham
• Treatments: alpha-Tocopherol; Selenium; Tocopherols; Tocotrienols; Vitamin E; Vitamins

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