Selenium in Preventing Cancer Recurrence in Patients With Bladder Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of selenium may keep bladder cancer from growing or coming back. It is not yet known whether selenium is more effective than a placebo in preventing cancer recurrence in patients with bladder cancer. PURPOSE: This randomized phase III trial is studying selenium to see how well it works compared with a placebo in preventing cancer recurrence in patients with bladder cancer.

Detailed Description
-----------------
OBJECTIVES: Primary To determine the effect of selenium, when administered with standard care, in preventing the recurrence of bladder cancer in patients with non-muscle-invasive transitional cell carcinoma of the bladder at risk for recurrence. Secondary To determine the effect of selenium on the recurrence of bladder cancer, in terms of histological type, number, and size. OUTLINE: Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive oral placebo daily in addition to standard care. Arm II: Patients receive oral selenium daily in addition to standard care.

Official Title
-----------------
Phase III Randomized Chemoprevention Study of Selenium on the Recurrence of Non-invasive Bladder Cancer

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Dietary Supplement: selenium
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histopathologically confirmed non-muscle-invasive transitional cell carcinoma (TCC) of the bladder (< pT2 ) PATIENT CHARACTERISTICS: Able to swallow pills Not pregnant Fertile patients must use effective contraception No other malignancy within the past 5 years No known hypersensitivity or adverse reactions to selenium No other serious medical or psychiatric illness that would preclude giving informed consent No condition that, in the opinion of the investigator, may interfere with the safety of the patient or the evaluation of the study objectives PRIOR CONCURRENT THERAPY: See Disease Characteristics More than 30 days since prior daily dietary supplements containing selenium No other concurrent selenium (contained in individual supplements, antioxidant mix, or multivitamin) intake No concurrent participation in another study involving a medical, surgical, nutritional, or lifestyle intervention Concurrent participation in the follow-up phase of another study allowed

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Arm I<br>Patients receive oral placebo daily in addition to standard care. | Other: placebo<br>* Given orally<br>|
| Experimental: Arm II<br>Patients receive oral selenium daily in addition to standard care. | Dietary Supplement: selenium<br>* Given orally<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of selenium in preventing the recurrence of bladder cancer |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of selenium on the progression of bladder cancer, in terms of histological type, number, and size |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage 0 bladder cancer, stage I bladder cancer, transitional cell carcinoma of the bladder