Breast Cancer
Conditions
Keywords
Breast cancer risk, DHA, Omega-3 Fatty Acids, EPA, Weight Loss
Brief summary
The purpose of this study is to determine if high dose supplementation with the omega-3 fatty acids EPA and DHA, when added to a weight loss program, is well tolerated in the study population and if there is an increase in the favorable change in blood and tissue breast cancer risk factors when compared to weight loss alone.
Detailed description
Subjects will all participate in a 6-month weight loss intervention. Subjects will be randomized to receive either blinded placebo or omega-3 fatty acids for 6 months.
Interventions
DIETARY_SUPPLEMENTOmega-3 Fatty Acids
Amber 4020 Ethyl Ester (EE) 1000 mg omega-3 capsule contains 420 mg of EPA and 210 mg of DHA both as the ethyl esters (380 mg EPA and 190 mg DHA)
OTHERPlacebo Capsule
OTHERDiet and Exercise
Increasing physical activity required over 6 month period to be tracked by a Fitbit. Diet based on caloric intake and eating approved foods.
Sponsors
DSM Nutritional Products, Inc.
Carol Fabian, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Evidence of Hyperplasia with Masood score of 13 or higher and 500 or more epithelial cells on cytology slide of screening Random Periareolar Fine Needle Aspiration (RPFNA) * Access to smart phone and or computer * Willing to comply with diet, exercise and lifestyle modification during weight reduction and maintenance phase. * Willing to start the dietary and exercise intervention within 9 months of RPFNA * Willing to complete quality of life questionnaires at multiple visits * Willing to have a medical history and physical at multiple visits * Willing to have an additional RPFNA at two additional visits * Be willing to have blood drawn at multiple visits * Willing to sign and able to understand consent for the RPFNA's and study participation * Reasonable hematopoetic, kidney and liver function consistent with safe participation on this trial.
Exclusion criteria
* Having taken medications that seriously affect metabolism such as steroids, dexatrim or other diet drugs within 3 weeks of study registration * Have changed dose or type of hormone supplementation within 3 months * Currently receiving other investigational agents * Have been on a chemoprevention trial within 6 months or taken a Selective Estrogen Receptor Modulator or aromatase inhibitor within last 6 months. * Need for chronic use of aspirin, nonsteroidal anti-inflamatory drug (NSAID) or other anti-inflammatory agents * Taking metformin, or other diabetes medications * Taking statins * Unable to participate in moderate intensity exercise (walking, treadmill, elliptical, water aerobics) * Would be unable to participate, by phone, in weekly phone call sessions * Cells suspicious for malignancy as assessed by cytotechnologist or cytopathologist.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dropout rate | Up to 6 Months | Measured as the number of participants that dropout before diet+intervention period is complete |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Study design feasibility | Up to 6 months | Based on eligibility criteria, study procedures and participation of subjects the study design will be measured to see if it will practically work with a larger study population |
| Modulation of breast cancer risk biomarkers | Change from Baseline to 6 Months | Measure the change in fasting and postprandial blood inflammatory, and risk biomarkers |
| Modulation of breast cancer risk biomarkers in benign breast tissue | Change from Baseline to 6 Months | Measure change in fasting and postprandial blood inflammatory, and risk biomarkers |
| Weight gain | Change from 6 Months to 12 Months | Measure change in weight in participants during the 6-12 month maintenance phase |
| Change in Gut Microbiome | Change from Baseline to Month 6 | Change in eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA):arachidonic acid (AA) ratio |
Countries
United States
Outcome results
None listed