Breast Cancer Clinical Trial
Weight Loss Plus Omega-3 Fatty Acids or Placebo in High Risk Women
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.
Full 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.
Eligibility Criteria
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.
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There is 1 Location for this study
Kansas City Kansas, 66205, United States
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