Breast Cancer Risk Biomarkers in Premenopausal Women
|ClinicalTrials.gov Identifier: NCT01252277|
Recruitment Status : Completed
First Posted : December 2, 2010
Results First Posted : July 21, 2016
Last Update Posted : July 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Lovaza™||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Modulation of Breast Cancer Risk Biomarkers in Premenopausal Women by High Dose Omega-3 Fatty Acids|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 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 an Intervention of Lovaza™ 4 Grams Per Day [ Time Frame: 6 month visit ]The proportion of subjects that complete an intervention of Lovaza™ 4 grams per day (~ 1800 mg EPA and 1500 mg DHA) administered for 6 months to premenopausal women under age 55.
- 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.
- Modulation of Ki-67 Expression [ Time Frame: 6 month value compared to baseline value ]Change (baseline to end of study) in percent of benign breast epithelial cells exhibiting immunostaining for Ki-67
- Change in (DHA+EPA):AA Ratio for Phospholipids in Plasma. [ Time Frame: baseline to end of intervention (~6 months) ]Change (from baseline to end of study) for the ratio derived from levels of DHA, EPA, and Arachadonic Acid (AA); measured as percent of total fatty acid content in the phospholipid compartment of plasma.
- Change in Quality of Life. [ Time Frame: duration of intervention, baseline to ~ 6 months ]Change in score on Breast Cancer Prevention Trial (BCPT) Symptom Checklist. 43 symptoms, each scored as 0 to 4, are summed to provide a global score (range 0 to 172). Increasing score represents increasing problems with side effects. For change in score over period of intervention, a negative score indicates an improvement in quality of life while a positive score indicates increasing interference with daily activities due to worsening symptoms. Theoretically, the range of change could be -172 to +172.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01252277
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Carol Fabian, MD||University of Kansas Medical Center|