Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033345
Status:
COMPLETED
Last Update Posted:
2016-08-18
First Post:
2002-04-09
Brief Title:
Indole-3-Carbinol in Preventing Breast Cancer in Nonsmoking Women Who Are at High Risk For Breast Cancer
Sponsor:
University of Kansas Medical Center
Organization:
University of Kansas Medical Center
Study Overview
Official Title:
Multiple Daily Dose Phase I Safety And Pharmacokinetic Clinical Study Of Indole-3-Carbinol
Status:
COMPLETED
Status Verified Date:
2016-08
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 or recurrence of cancer Indole-3-carbinol may be effective in preventing breast cancer
PURPOSE Phase I trial to study the effectiveness of indole-3-carbinol in preventing breast cancer in nonsmoking women who are at high risk for breast cancer
PURPOSE Phase I trial to study the effectiveness of indole-3-carbinol in preventing breast cancer in nonsmoking women who are at high risk for breast cancer
Detailed Description:
OBJECTIVES
Determine the safety and tolerability of indole-3-carbinol for the prevention of breast cancer in non-smoking women at high risk for breast cancer
Determine the pharmacokinetics of this drug in these participants
Determine the effect of this drug on metabolites of estrogen in urine of these participants
Determine other additional effects of this drug on selected indicators of drug metabolism and reproductive and hormonal function in these participants
Assess any possible antineoplastic activity of this drug in these participants
Determine the quality of life of participants receiving this drug
OUTLINE This is a single-blind study
Participants ingest study compound twice daily on weeks 1-12 or 1-16 Study compound is dispensed on weeks 1 5 and 9 At times study compound is oral placebo and at other times oral indole-3-carbinol
Quality of life is assessed at baseline and then every 4 weeks during study therapy
PROJECTED ACCRUAL A total of 18 participants will be accrued for this study within 9 months
Determine the safety and tolerability of indole-3-carbinol for the prevention of breast cancer in non-smoking women at high risk for breast cancer
Determine the pharmacokinetics of this drug in these participants
Determine the effect of this drug on metabolites of estrogen in urine of these participants
Determine other additional effects of this drug on selected indicators of drug metabolism and reproductive and hormonal function in these participants
Assess any possible antineoplastic activity of this drug in these participants
Determine the quality of life of participants receiving this drug
OUTLINE This is a single-blind study
Participants ingest study compound twice daily on weeks 1-12 or 1-16 Study compound is dispensed on weeks 1 5 and 9 At times study compound is oral placebo and at other times oral indole-3-carbinol
Quality of life is assessed at baseline and then every 4 weeks during study therapy
PROJECTED ACCRUAL A total of 18 participants will be accrued for this study within 9 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 |
|---|---|---|---|
| NCI-P02-0217 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000069276 | REGISTRY | None | None |