Finding studies
Finding studies
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Lead
National Cancer Institute (NCI)
PRIMARY OBJECTIVES: I. To determine whether treatment with docosahexaenoic acid (DHA) for 12 weeks at 1000 mg twice daily as compared to placebo reduces normal breast tissue levels of tumor necrosis factor-alpha (TNF-alpha) in overweight and obese patients with a history of stage I-III invasive breast cancer, ductal carcinoma in situ (DCIS), Paget's disease, lobular carcinoma in situ (LCIS), or proliferative benign breast disease. SECONDARY OBJECTIVES: I. To investigate the effect of DHA at 1000 mg twice daily on tissue biomarkers * Change from the baseline in cyclooxygenase-2 (COX-2)/interleukin-1-beta (IL-1beta)/aromatase measured by quantitative real-time polymerase chain reaction (PCR). * Change from the baseline in crown-like structures of the breast (CLS-B) measured by immunohistochemical techniques for cluster of differentiation (CD)68. * Change from baseline in CLS-B index determined as follows: (\[number of slides with evidence of at least one CLS-B\]/\[total number of slides examined\]). * Change from baseline in CLS-B/cm\^2 defined as the number of CLS-B/cm\^2. II. Evaluate age as a predictor of CLS-B and inflammatory biomarkers (TNF-alpha/COX-2/IL-1beta) at baseline and over the time of treatment. III. Evaluate red blood cell (RBC) fatty acid level as a surrogate of compliance. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive docosahexaenoic acid orally (PO) twice daily (BID) for 12 weeks. ARM II: Patients receive placebo PO BID for 12 weeks.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
