Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114296
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
2005-06-13
Brief Title:
Omega-3 Fatty Acids in Preventing Breast Cancer in Women at High Risk of Developing Breast Cancer
Sponsor:
Cedars-Sinai Medical Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Pilot Study to Evaluate the Effects of Omega-3 Fatty Acids on Intermediate Markers of Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2006-07
Last Known Status:
ACTIVE_NOT_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 supplements to keep cancer from forming growing or coming back The use of omega-3 fatty acids may prevent breast cancer
PURPOSE This randomized clinical trial is studying how well omega-3 fatty acids work in preventing breast cancer in women at high risk of developing breast cancer
PURPOSE This randomized clinical trial is studying how well omega-3 fatty acids work in preventing breast cancer in women at high risk of developing breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the effects of omega-3 fatty acids on mammographic breast density MBD in women at high risk of developing breast cancer
Secondary
Determine preliminarily the effects of this supplement on cell atypia and breast cell proliferation measured in ductal lavage specimens from these patients
Determine the effects of this supplement on circulating hormone and growth factor blood levels in these patients
Determine the effects of this supplement on the expression of estrogen-related proteins found in ductal lavage specimens from these patients
Determine the effects of this supplement on plasma lipid peroxidation levels in these patients
Correlate the modifying effect of lipid peroxidation-related genes with MBD in patients treated with this supplement
OUTLINE This is a randomized pilot study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral placebo three times daily for 12 months
Arm II Patients receive oral omega-3 fatty acids three times daily for 12 months
In both arms treatment continues in the absence of the development of ductal carcinoma in situ or invasive carcinoma of the breast or unacceptable toxicity
PROJECTED ACCRUAL A total of 80 patients 40 per treatment arm will be accrued for this study
Primary
Determine the effects of omega-3 fatty acids on mammographic breast density MBD in women at high risk of developing breast cancer
Secondary
Determine preliminarily the effects of this supplement on cell atypia and breast cell proliferation measured in ductal lavage specimens from these patients
Determine the effects of this supplement on circulating hormone and growth factor blood levels in these patients
Determine the effects of this supplement on the expression of estrogen-related proteins found in ductal lavage specimens from these patients
Determine the effects of this supplement on plasma lipid peroxidation levels in these patients
Correlate the modifying effect of lipid peroxidation-related genes with MBD in patients treated with this supplement
OUTLINE This is a randomized pilot study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral placebo three times daily for 12 months
Arm II Patients receive oral omega-3 fatty acids three times daily for 12 months
In both arms treatment continues in the absence of the development of ductal carcinoma in situ or invasive carcinoma of the breast or unacceptable toxicity
PROJECTED ACCRUAL A total of 80 patients 40 per treatment arm 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 |
|---|---|---|---|
| CSMC-00006359 | None | None | None |
| CSMC-00000509 | None | None | None |