Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084344
Status:
COMPLETED
Last Update Posted:
2012-05-30
First Post:
2004-06-10
Brief Title:
Effect of 4-Hydroxytamoxifen Gel on Breast Density Salivary Sex Steroids and Quality of Life in Premenopausal Women
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Prospective Randomized Placebo-Controlled Trial of the Effects of 4-Hydroxytamoxifen Gel on Breast Density Salivary Sex Steroids and Quality of Life in Premenopausal Women
Status:
COMPLETED
Status Verified Date:
2012-05
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 High estrogen levels may be associated with dense breast tissue and an increased risk of developing breast cancer 4-hydroxytamoxifen gel a substance made when tamoxifen breaks down in the body may be effective in reducing breast density by reducing estrogen levels with fewer side effects than tamoxifen This may improve quality of life and the ability to detect breast cancer with screening mammography
PURPOSE Randomized screening study to determine the effect of 4-hydroxytamoxifen gel on breast density salivary sex steroids hormones and quality of life in premenopausal women
PURPOSE Randomized screening study to determine the effect of 4-hydroxytamoxifen gel on breast density salivary sex steroids hormones and quality of life in premenopausal women
Detailed Description:
OBJECTIVES
Primary
Determine the effect of 4-hydroxytamoxifen gel on breast density as measured by digital mammography in premenopausal women
Determine the effect of this gel on breast density in these participants as defined by the BIRADS lexicon
Secondary
Determine the effect of this gel on salivary sex steroid levels in these participants
Determine the effect of this gel on quality of life of these participants
OUTLINE This is a randomized double-blind placebo-controlled study Participants are randomized to 1 of 2 treatment arms
Arm I Participants apply 4-hydroxytamoxifen gel in 4 metered doses daily to each breast beginning on the first day after cessation of the first menstrual period after digital mammography is performed
Arm II Participants apply placebo gel as in arm I In both arms treatment continues for 1 year
In both arms participants collect daily saliva samples for 4 menstrual cycles during the study Three of the saliva collections occur during the cycles encompassing the time periods when imaging studies are performed months 0 6 and 12 The fourth collection takes place during the first month that gel is applied to the breast
Participants also undergo digital mammography at baseline 6 months and 1 year
Participants who develop clinical breast problems considered suspicious for cancer discontinue study treatment until a histological diagnosis is established Those found to have breast cancer are removed from the study and those with benign disease continue the study If an excisional biopsy is performed density measurements are made on the opposite breast
Quality of life is assessed at baseline 1 month 6 months and 1 year
PROJECTED ACCRUAL A total of 100 participants 50 per treatment arm will be accrued for this study
Primary
Determine the effect of 4-hydroxytamoxifen gel on breast density as measured by digital mammography in premenopausal women
Determine the effect of this gel on breast density in these participants as defined by the BIRADS lexicon
Secondary
Determine the effect of this gel on salivary sex steroid levels in these participants
Determine the effect of this gel on quality of life of these participants
OUTLINE This is a randomized double-blind placebo-controlled study Participants are randomized to 1 of 2 treatment arms
Arm I Participants apply 4-hydroxytamoxifen gel in 4 metered doses daily to each breast beginning on the first day after cessation of the first menstrual period after digital mammography is performed
Arm II Participants apply placebo gel as in arm I In both arms treatment continues for 1 year
In both arms participants collect daily saliva samples for 4 menstrual cycles during the study Three of the saliva collections occur during the cycles encompassing the time periods when imaging studies are performed months 0 6 and 12 The fourth collection takes place during the first month that gel is applied to the breast
Participants also undergo digital mammography at baseline 6 months and 1 year
Participants who develop clinical breast problems considered suspicious for cancer discontinue study treatment until a histological diagnosis is established Those found to have breast cancer are removed from the study and those with benign disease continue the study If an excisional biopsy is performed density measurements are made on the opposite breast
Quality of life is assessed at baseline 1 month 6 months and 1 year
PROJECTED ACCRUAL A total of 100 participants 50 per treatment arm 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 |
|---|---|---|---|
| NU-0365-011 | None | None | None |
| NU-NCI-00B3 | None | None | None |
| NU-3 | None | None | None |