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

Sponsor

University of Birmingham (Other)

Overall Status

Unknown status

CT.gov ID

NCT00553345

Collaborator

(none)

515

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer	Drug: selenium Drug: vitamin E Procedure: chemoprevention	Phase 3

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Masking:

Double

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Dec 1, 2005

Outcome Measures

Primary Outcome Measures

Recurrence-free interval []

Secondary Outcome Measures

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 []
Progression-free interval []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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