Selenium in the Prevention of Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. Selenium may be effective in preventing cancer. It is not yet known which dose of selenium may be most effective in preventing cancer. PURPOSE: Randomized pilot study to determine the effectiveness of selenium in preventing cancer in healthy people.

Detailed Description
-----------------
OBJECTIVES: I. Determine whether daily supplementation with selenium significantly reduces total cancer incidence and site-specific cancer incidence in the general population. II. Determine whether this regimen has a beneficial effect on mood. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Participants are stratified according to age (60-64 vs 65-69 vs 70-74). Participants are randomized to one of four arms. Arm I: Participants receive oral placebo once daily. Arm II: Participants receive low-dose oral selenium once daily. Arm III: Participants receive moderate-dose oral selenium once daily. Arm IV: Participants receive high-dose oral selenium once daily. Treatment in all arms continues for up to 2 years in the absence of unacceptable side effects or diagnosis of cancer. PROJECTED ACCRUAL: A total of 510 patients (170 per stratum) will be accrued for this study within 9-12 months.

Official Title
-----------------
Prevention Of Cancer By Intervention With Selenium

Conditions
-----------------
Unspecified Adult Solid Tumor, Protocol Specific

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


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Healthy men and women No prior diagnosis of cancer except non-melanoma skin cancer PATIENT CHARACTERISTICS: Age: 60 to 74 Performance status: SWOG 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: No active liver disease No known abnormal liver function Renal: No active kidney disease No known abnormal kidney function Other: HIV negative No diminished mental capacity that would preclude study PRIOR CONCURRENT THERAPY: No other concurrent selenium supplements (50 ug/day or more)

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 74 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Selenium yeast | Dietary Supplement: selenium<br> <br> |
| Experimental: Selenium yeast 100 micrograms per day<br>100 micrograms per day | Dietary Supplement: selenium<br> <br> |
| Experimental: Selenium yeast 200 micrograms per day<br>200 micrograms per day | Dietary Supplement: selenium<br> <br> |
| Experimental: Selenium yeast 300 micrograms per day<br>300 micrograms per day | Dietary Supplement: selenium<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
unspecified adult solid tumor, protocol specific