Omega-3 Fatty Acid in Treating Patients With Stage I-III Breast Cancer
NCT ID: NCT01869764
Last Updated: 2019-10-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
57 participants
INTERVENTIONAL
2013-11-30
2018-07-31
Brief Summary
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Detailed Description
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I. To determine if omega-3 dietary supplementation (omega-3 fatty acid) results in higher polyunsaturated fatty acids (PUFA) levels in surgical specimens of normal and malignant breast tissue in women who took omega 3 tablets in comparison to those who took placebo.
II. To determine if omega-3 dietary supplementation results in higher PUFA levels in plasma and red blood cells in women who took omega 3 tablets in comparison to those who took placebo.
III. To determine if omega-3 dietary supplementation affects the metabolites of omega-3 and omega-6 PUFA in surgical specimens of malignant and normal breast tissue in comparison to controls.
IV. To determine if women who take omega-3 dietary supplementation have less proliferation and greater apoptosis in malignant breast tissue in comparison to women who take placebo.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive omega-3 fatty acid orally (PO) daily for 7-14 days.
ARM II: Patients receive placebo PO daily for 7-14 days.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I (omega-3 fatty acid)
Patients receive omega-3 fatty acid PO daily for 7-14 days.
omega-3 fatty acid
Given PO
laboratory biomarker analysis
Correlative studies
Arm II (placebo)
Patients receive placebo PO daily for 7-14 days.
placebo
Given PO
laboratory biomarker analysis
Correlative studies
Interventions
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omega-3 fatty acid
Given PO
placebo
Given PO
laboratory biomarker analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Breast surgery (lumpectomy or mastectomy) is planned for at least 7 days from the day of enrollment
* Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved written informed consent document
* Tumor measures at least 1 centimeter on imaging or physical exam
Exclusion Criteria
* Patients who are unable to refrain from the use of any NSAID or full-dose acetylsalicylic acid (ASA)-containing NSAID while taking study drug
* Patients who will receive neoadjuvant chemotherapy are not eligible
* Patients who are currently taking omega-3 fatty acids, as they are unable to be randomized to placebo
* Patients who have previously taken omega-3 fatty acid within 1 month prior to study enrollment
* Patients with an allergy or known hypersensitivity to fish
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Edward Levine, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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NCI-2013-00963
Identifier Type: REGISTRY
Identifier Source: secondary_id
CCCWFU 98113
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00023419
Identifier Type: -
Identifier Source: org_study_id
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