Clinical TrialsThe James Cancer Center Columbus, OH
open for enrollment
Omega-3 Fatty Acids in Preventing Recurrence in Patients with Hormone Receptor-Negative or HER2-Positive Stage 0-III Breast Cancer That Have Completed Treatment
Omega-3 fatty acids and ERPR(-) and HER-2/neu(+) breast cancer prevention
This randomized clinical trial studies omega-3 fatty acids in preventing the return of cancer (recurrence) in patients with hormone receptor-negative or human epidermal growth factor receptor (HER2)-positive stage 0-III breast cancer that have completed treatment. Omega-3 fatty acid may help prevent breast cancer from forming in patients at risk for recurrence.
I. Modify the content of fatty acid metabolites (e.g. prostaglandin [PG]E2, PGE3) in breast adipose tissue samples obtained by fine needle aspiration at baseline, 3, 6, 9 and 12 months in a dose, time dependent fashion.
II. Modulate cytomorphology and/or cell proliferation of mammary epithelial cells obtained by random periareolar fine needle aspiration (RPFNA) at baseline, 6 and 12 months with correlation to breast adipose tissue docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), omega-3:omega-6 ratio and dose over time.
III. Modify the state of promoter deoxyribonucleic acid (DNA) methylation of p16, glutathione peroxidase 3 (plasma) (GPX3), and phosphatase and tensin homolog (PTEN) in mammary epithelial and adipose tissue samples at 0, 6 and 12 months of omega-3 polyunsaturated fatty acids (PUFA) treatment in a dose, time dependent fashion.
IV. Modulate pro-inflammatory (e.g. COX-2, interleukin [IL]-6, tumor necrosis factor [TNF]-alpha [a]) and anti-inflammatory/antioxidant (e.g. PTEN, GPX3, heme oxygenase [decycling] 1 [HMOX1]) gene expression patterns in breast adipose tissue samples obtained by fine needle aspiration (FNA) by quantitative real time-polymerase chain reaction (RT-PCR).
I. Evaluation of possible associations between breast adipose tissue or erythrocyte membrane fatty acids (e.g. EPA, DHA and/or omega-3:omega-6 ratio), physical factors such as body mass index (BMI), dietary information, HER-2/neu overexpression and biomarkers.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive high-dose omega-3 acid orally (PO) once daily (QD) for 12 months.
ARM II: Patients receive low-dose omega-3 acid PO QD and placebo PO QD for 12 months.
Are you eligible?
Prior diagnosis of stage 0 to III breast cancer that is estrogen receptor negative, progesterone receptor negative with completion of definitive surgery, radiation therapy and/or chemotherapy
Completion of chemotherapy or trastuzumab for > six months and of radiation therapy for >= 2 months, as applicable and 2 years or less from completion of standard therapy
Greater than 1 year from pregnancy, lactation
Mammogram performed or reviewed by an Ohio State University (OSU) radiologist at the Stefanie Spielman Comprehensive Breast Center or the James Cancer Hospital within the six months prior to study enrollment that are not suspicious for breast cancer (American College of Radiology [ACR] class I-III); subjects with a class IV mammogram may be entered following a negative biopsy
Must be willing to undergo fine needle aspiration of the contralateral breast for breast adipose tissue at 0, 3, 6, 9 and 12 months of the study and breast epithelial tissue samples at 0, 6 and 12 months of study
Must be willing to have about 30 ml of blood drawn at 0, 6 and 12 months and about 5-10 ml of blood at 3 and 9 months
No history of diabetes mellitus or stroke, or bleeding tendency
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (fully active or restricted only in physically strenuous activity)
Hemoglobin >= 9 g/dL
Platelets >= 100,000/mm^3
Fasting blood glucose =< 115 mg/dL
Transaminases (aspartate aminotransferase [AST], alanine aminotransferase [ALT]) =< 1.5 x upper limit of normal (ULN)
Negative pregnancy test for women of childbearing potential
Other current malignancy or metastatic malignancy of any kind
Ongoing chemotherapy, radiation therapy, or other cancer-related treatment
Subjects on Coumadin or other anticoagulants
Subjects with breast implants
Subjects who have had radiation to both breasts or who have undergone bilateral mastectomies
Subjects with insufficient breast adipose tissue and/or parenchymal breast tissue/breast density for adequate FNA sampling as determined by clinical examination and/or mammography
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, hypertension, or psychiatric illness/social situation that would limit compliance with study requirements
Chronic use of omega-3 fatty acid concentrates or capsules within the 3 months prior to entry on the study or any other supplements that might interact with omega-3 fatty acid supplements
Pregnant or nursing women
Known sensitivity or allergy to fish
Subjects on a standing regimen of full dose aspirin (>= 325 mg/day), nonsteroidal anti-inflammatory drugs (NSAIDs) or NSAID-containing products