study of docosahexaenoic acid (dha) in triple negative breast cancer survivors

Conditions: Benign Breast Neoplasm; Ductal Breast Carcinoma In Situ; Invasive Breast Carcinoma; Lobular Breast Carcinoma In Situ; Paget Disease of the Breast; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer

Summary: this randomized phase ii trial studies how well docosahexaenoic acid works in preventing recurrence in breast cancer survivors. docosahexaenoic acid supplement may prevent recurrence in breast cancer survivors.

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.

Eligibility criteria:
inclusion criteria: * participants must have a history of histologically-confirmed stage i-iii invasive breast cancer or ductal carcinoma in situ (dcis), paget's disease, lobular carcinoma in situ (lcis), or proliferative benign breast disease * no evidence of disease (in situ or invasive cancer that would normally be treated by resection) at trial entry as determined by the investigator * \>= 6 months from all previous breast cancer treatment (including surgery for invasive cancer, chest wall radiotherapy, chemotherapy, trastuzumab and endocrine therapy) * participants must have a body mass index (bmi) \>= 25, defined as (weight in kilograms/\[height in meters\]\^2) * participants must have adequate accessible breast tissue as determined by the treating physician, consisting of one breast unaffected by invasive cancer, which has not been radiated; a history of prior pre-invasive breast cancer or benign biopsy of this breast will be permitted * daily dha consumption =\< 200 mg/day in the month prior to screening estimated by an abbreviated dha food frequency questionnaire * mammogram within no more than 6 months prior to the date of informed consent (normal/benign breast imaging-reporting and data system \[bi-rads\] 1 or 2) and no further routine breast imaging planned during the course of the study (12 weeks dha/placebo) * eastern cooperative oncology group (ecog) performance status must be =\ = 60%) * absolute neutrophil count \>= 1,500/ul * platelets \>= 75,000/ul * white blood cells \>= 3,000/ul * hemoglobin \>= 10 g/dl * total bilirubin within 1.5 times the institution's upper limit of normal (uln) * aspartate aminotransferase (ast) (serum glutamic oxaloacetic transaminase \[sgot\])/alanine aminotransferase (alt) (serum glutamate pyruvate transaminase \[sgpt\]) within 1.5 times the institution's uln * serum creatinine within 1.5 times the institution's uln * pregnant women will be excluded; for women of childbearing potential; negative pregnancy testing within 72 hours prior to or on study visit #1 (day 0) and willingness to use adequate contraception during the study intervention or post-menopausal defined as any one of the following 1) prior hysterectomy, 2) absence of menstrual period for 1 year in the absence of prior chemotherapy or 3) absence of menstrual period for 2 years in women with a prior history of chemotherapy exposure who were pre-menopausal prior to chemotherapy * willingness to comply with all study interventions and follow-up procedures including the ability to swallow the study drug * ability to understand and the willingness to sign a written informed consent document exclusion criteria: * any type of active invasive cancer (excluding breast and non-melanoma skin cancer) within the preceding 18 months * a history of histologically-confirmed bilateral invasive breast cancer * bilateral mastectomy * prior history or evidence of metastatic breast cancer * prior radiation therapy to the contralateral (unaffected) breast * prior history of contralateral (unaffected) breast augmentation with breast implant placement * history of daily use of aspirin or non-steroidal anti-inflammatory drugs (nsaids) in the week preceding study entry * history of dha supplementation \> 200 mg/day in the month preceding study entry * history of autoimmune disorder or any illness that requires therapy with chronic steroids or immunomodulators * history of therapeutic doses of anticoagulants including warfarin and low molecular weight heparin (e.g. for prior deep venous thrombosis and pulmonary embolism) in the preceding year * participants may not be receiving any other investigational agents during the study * women who have received cancer surgery, chemotherapy, biological therapy (e.g., trastuzumab), or radiotherapy for the treatment of any cancer within 6 months of study participation * women who are receiving endocrine therapy for breast cancer treatment or chemoprevention including tamoxifen, letrozole, anastrozole, fulvestrant, or exemestane at the time of screening * individuals with severe underlying chronic illness, such as uncontrolled diabetes; ongoing or active infection, psychiatric illness or social situations which in the opinion of the investigator would interfere with study participation * history of allergic reactions attributed to compounds of similar chemical or biologic composition to dha or corn/soy oil in placebo agent * pregnant, breastfeeding, or women of childbearing potential unwilling to use a reliable contraceptive method