Docosahexaenoic Acid in Preventing Recurrence in Breast Cancer Survivors

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)

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