Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00322114
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2006-05-03
Brief Title:
Lycopene in Preventing Prostate Cancer in Healthy Participants
Sponsor:
University of Illinois at Chicago
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Mechanism of Prostate Cancer Prevention by Lycopene
Status:
UNKNOWN
Status Verified Date:
2009-07
Last Known Status:
RECRUITING
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 is the use of certain drugs or substances to keep cancer from forming growing or coming back The use of lycopene a substance found in tomatoes may keep prostate cancer from forming
PURPOSE This randomized clinical trial is studying how well lycopene works in preventing prostate cancer in healthy participants
PURPOSE This randomized clinical trial is studying how well lycopene works in preventing prostate cancer in healthy participants
Detailed Description:
OBJECTIVES
Primary
Determine whether lycopene supplementation affects percent free and bound prostate-specific antigen PSA in healthy participants
Secondary
Determine whether lycopene reduces oxidative stress in these participants as indicated by lipid peroxidation assay
Determine whether a 21-day washout period is sufficient to return lycopene PSA and lipid peroxidation products to baseline
OUTLINE This is a randomized placebo-controlled study Participants are randomized to 1 of 3 treatment arms
Arm I Participants receive an oral tomato dietary supplement containing lycopene twice daily for 3 weeks
Arm II Participants receive an oral tomato dietary supplement containing lycopene at a higher dose twice daily for 3 weeks
Arm III Participants receive oral placebo twice daily for 3 weeks Urine and blood samples are collected on days 0 21 and 42
PROJECTED ACCRUAL A total of 150 participants will be accrued for this study
Primary
Determine whether lycopene supplementation affects percent free and bound prostate-specific antigen PSA in healthy participants
Secondary
Determine whether lycopene reduces oxidative stress in these participants as indicated by lipid peroxidation assay
Determine whether a 21-day washout period is sufficient to return lycopene PSA and lipid peroxidation products to baseline
OUTLINE This is a randomized placebo-controlled study Participants are randomized to 1 of 3 treatment arms
Arm I Participants receive an oral tomato dietary supplement containing lycopene twice daily for 3 weeks
Arm II Participants receive an oral tomato dietary supplement containing lycopene at a higher dose twice daily for 3 weeks
Arm III Participants receive oral placebo twice daily for 3 weeks Urine and blood samples are collected on days 0 21 and 42
PROJECTED ACCRUAL A total of 150 participants will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UIC-2004-0217 | None | None | None |