Study of Docosahexaenoic Acid (DHA) in Triple Negative Breast Cancer Survivors
Condition: 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
MeSH terms: Carcinoma; Breast Neoplasms; Carcinoma in Situ; Carcinoma, Ductal, Breast; Breast Carcinoma In Situ; Carcinoma, Intraductal, Noninfiltrating; Carcinoma, Lobular; Paget's Disease, Mammary; Breast Diseases
Intervention: Docosahexaenoic Acid; Placebo
Intervention description: Given PO; Given PO
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 65.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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 =< 2 (Karnofsky
             >= 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