Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00099008
Status:
COMPLETED
Last Update Posted:
2013-05-21
First Post:
2004-12-08
Brief Title:
Genistein in Preventing Breast or Endometrial Cancer in Healthy Postmenopausal Women
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
Official Title:
Phase I Multiple Dose Clinical Study of Soy Isoflavones in Healthy Post-Menopausal Women
Status:
COMPLETED
Status Verified Date:
2013-05
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 The use of genistein may be effective in preventing breast or endometrial cancer
PURPOSE This randomized phase I trial is studying the effectiveness of genistein in preventing breast or endometrial cancer in healthy postmenopausal women
PURPOSE This randomized phase I trial is studying the effectiveness of genistein in preventing breast or endometrial cancer in healthy postmenopausal women
Detailed Description:
OBJECTIVES
Compare the effects of genistein vs placebo on DNA damage and apoptosis by conducting COMET TUNEL Caspase-3 and AP site assays in healthy postmenopausal women
Compare the effects of these drugs on gene expression in an estrogen-sensitive tissue by oligoarray profiling in these participants
Determine the effect of genistein on estrogenic effects by self-reported side effects measurement of sex hormone-binding globulin follicle-stimulating hormone luteinizing hormone and estrogen levels and expression of known estrogen-sensitive genes in these participants
OUTLINE This is a randomized double-blind placebo-controlled study Participants are stratified according to their study ID numbers Participants are randomized to 1 of 2 treatment arms
Arm I Participants receive oral genistein twice daily on days 1-84
Arm II Participants receive oral placebo twice daily on days 1-84 In both arms treatment continues in the absence of dysplasia malignancy unacceptable toxicity or gross noncompliance
Participants are followed at days 7 14 28 56 and 84 during study treatment and at day 28 after completion of study treatment
PROJECTED ACCRUAL A total of 30 participants 20 for arm I and 10 for arm II will be accrued for this study
Compare the effects of genistein vs placebo on DNA damage and apoptosis by conducting COMET TUNEL Caspase-3 and AP site assays in healthy postmenopausal women
Compare the effects of these drugs on gene expression in an estrogen-sensitive tissue by oligoarray profiling in these participants
Determine the effect of genistein on estrogenic effects by self-reported side effects measurement of sex hormone-binding globulin follicle-stimulating hormone luteinizing hormone and estrogen levels and expression of known estrogen-sensitive genes in these participants
OUTLINE This is a randomized double-blind placebo-controlled study Participants are stratified according to their study ID numbers Participants are randomized to 1 of 2 treatment arms
Arm I Participants receive oral genistein twice daily on days 1-84
Arm II Participants receive oral placebo twice daily on days 1-84 In both arms treatment continues in the absence of dysplasia malignancy unacceptable toxicity or gross noncompliance
Participants are followed at days 7 14 28 56 and 84 during study treatment and at day 28 after completion of study treatment
PROJECTED ACCRUAL A total of 30 participants 20 for arm I and 10 for arm II will be accrued for this study
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 |
|---|---|---|---|
| CDR0000393450 | OTHER | PDQ number | None |