Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00093561
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2004-10-06
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:
Phase I Single Dose Pharmacokinetic Study of the Dietary Supplement Lycopene Delivered in Capsule Form to Healthy Male Volunteers Between 18 and 45 Years of Age
Status:
COMPLETED
Status Verified Date:
2006-11
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 substances to try to prevent the development or recurrence of cancer The dietary supplement lycopene may prevent the development of prostate cancer
PURPOSE This phase I trial is studying the side effects and best dose of lycopene in preventing prostate cancer in healthy participants
PURPOSE This phase I trial is studying the side effects and best dose of lycopene in preventing prostate cancer in healthy participants
Detailed Description:
OBJECTIVES
Determine the toxicity and safety of lycopene supplementation as chemoprevention for prostate cancer in healthy participants
Determine the pharmacokinetics of this agent in these participants
Determine the dose range of this agent in these participants
OUTLINE This is a dose-escalation study
Participants ingest a single-dose of oral lycopene over a maximum of 15 minutes on day 1
Cohorts of 5 participants receive escalating doses of lycopene until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 5 participants experience dose-limiting toxicity
Participants are evaluated periodically for 28 days
PROJECTED ACCRUAL A total of 25 participants will be accrued for this study
Determine the toxicity and safety of lycopene supplementation as chemoprevention for prostate cancer in healthy participants
Determine the pharmacokinetics of this agent in these participants
Determine the dose range of this agent in these participants
OUTLINE This is a dose-escalation study
Participants ingest a single-dose of oral lycopene over a maximum of 15 minutes on day 1
Cohorts of 5 participants receive escalating doses of lycopene until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 5 participants experience dose-limiting toxicity
Participants are evaluated periodically for 28 days
PROJECTED ACCRUAL A total of 25 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 |
|---|---|---|---|
| CDR0000389223 | REGISTRY | PDQ Physician Data Query | None |