Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022165
Status:
COMPLETED
Last Update Posted:
2015-08-11
First Post:
2001-08-10
Brief Title:
Selenium in the Prevention of Cancer
Sponsor:
University of Surrey
Organization:
University of Surrey
Study Overview
Official Title:
Prevention Of Cancer By Intervention With Selenium
Status:
COMPLETED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20113 | None | None | None |
| SURREY-UK-PRECISE | None | None | None |