Weight Loss Plus Omega-3 Fatty Acids or Placebo in High Risk Women

Randomized Pilot Trial of Omega-3 Fatty Acids or Placebo in Peri- or Post-Menopausal Women at High Risk for Breast Cancer Undergoing a Weight Loss Intervention

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.

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.

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.