Breast Cancer Risk Biomarkers in Postmenopausal Women
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|ClinicalTrials.gov Identifier: NCT01252290|
Recruitment Status : Completed
First Posted : December 2, 2010
Results First Posted : December 16, 2016
Last Update Posted : December 16, 2016
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Lovaza™||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Modulation of Breast Cancer Risk Biomarkers in Postmenopausal Women by High Dose Omega-3 Fatty Acids|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
Lovaza™ (two 1 gram capsules twice daily) for six months
4 capsules daily for 6 months
Other Name: esters of EPA and DHA
- The Proportion of Subjects That Complete Intervention of Lovaza™ 4 Grams Per Day [ Time Frame: 6 month visit ]To determine the feasibility of an intervention of Lovaza™ 4 grams per day (~ 1800 mg EPA and 1500 mg DHA) administered for 6 months to post-menopausal women under the age of 50.
- Modulation of the Risk Biomarker Masood Score [ Time Frame: 6 month value compared to baseline value ]Change in the semiquantitative cytology index score (Masood score) from baseline to end of study. Masood Score range 6 - 24; increasing values denote increasing cytologic abnormality. Thus, negative values for change reflect an improvement, i.e., less cytologic abnormality after intervention.
- Change in (DHA+EPA):AA Ratio for Phospholipids in Plasma [ Time Frame: Change from Baseline to Month 6 ]Change (from baseline to end of study) for the ratio derived from levels of DHA, EPA, and AA (measured as percent of total fatty acid content) in the phospholipid compartment of plasma.
- Change in Quality of Life [ Time Frame: Change from Baseline to Month 6 ]Change in score on Breast Cancer Prevention Trial (BCPT) Symptom Checklist. Summation score of degree of difficulty (scored 0 to 4 each) with 43 individual activities. Thus total score ranges from 0 to 172. Increasing score represents increasing problems with side effects.
- Change in Ki-67 Expression [ Time Frame: 6 month value compared to baseline value ]Immunocytochemical staining for Ki-67 antibody. Percent of 500 benign breast epithelial cells scored that are classified as positively staining.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01252290
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Carol Fabian, MD||University of Kansas Medical Center|