Weight Loss Plus Omega-3 Fatty Acids or Placebo in High Risk Women
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 45 - 70 |
| Updated: | 2/8/2019 |
| Start Date: | March 2014 |
| End Date: | August 27, 2018 |
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.
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.
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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