Omega-3 Fatty Acid in Treating Patients With Stage I-III Breast Cancer

Study Overview
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Brief Summary
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This phase II clinical trial studies how well omega-3 fatty acid works in treating patients with stage I-III breast cancer. Studying samples of tissue and blood in the laboratory from breast cancer patients receiving omega-3 fatty acid may help doctors learn more about the effects of omega-3 fatty acid on tumor cells.

Detailed Description
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PRIMARY OBJECTIVES: 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.

Official Title
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A Randomized, Placebo-Controlled Phase II Clinical Trial of Omega-3 PUFA Dietary Supplementation in Patients With Stage I-III Breast Carcinoma

Conditions
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Male Breast Cancer, Ductal Breast Carcinoma in Situ, Lobular Breast Carcinoma in Situ, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer

Intervention / Treatment
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* Drug: omega-3 fatty acid
* Other: placebo
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed stage I to III breast cancer and carcinoma in situ (including lobular carcinoma in situ [LCIS] and ductal carcinoma in situ [DCIS]) 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: Any patient with surgery scheduled < 7days after biopsy 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (omega-3 fatty acid)<br>Patients receive omega-3 fatty acid PO daily for 7-14 days. | Drug: omega-3 fatty acid<br>* Given PO<br>* Other names: O3FA;Other: laboratory biomarker analysis<br>* Correlative studies<br>|
| Placebo Comparator: Arm II (placebo)<br>Patients receive placebo PO daily for 7-14 days. | Other: placebo<br>* Given PO<br>* Other names: PLCB;Other: laboratory biomarker analysis<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PUFA Levels in Normal and Metastatic Breast Tissue | Analysis of variance (ANOVA) will be used to assess the effect of omega-3 dietary supplementation on PUFA levels separately in normal and malignant breast tissue. Analysis of covariance (ANCOVA) will be used to assess the omega-3 effect in plasma and red blood cells (RBC), where the baseline levels of the PUFAs will be included as covariates. PUFA Levels analyzed were 18:2 n-6, 18:3 n-3, 20:2 n-6, 20:4 n-6, 20:3 n-3, 20:5 n-3, 22:6 n-3 | At time of surgery | 
| PUFA Levels in Plasma Pre and Post Surgery | Analysis of variance (ANOVA) will be used to assess the effect of omega-3 dietary supplementation on PUFA levels separately in normal and malignant breast tissue. Analysis of covariance (ANCOVA) will be used to assess the omega-3 effect in plasma and red blood cells (RBC), where the baseline levels of the PUFAs will be included as covariates. PUFA Levels analyzed were 18:2 n-6, 18:3 n-3, 20:2 n-6, 20:4 n-6, 20:3 n-3, 20:5 n-3, 22:6 n-3 | Pre and post surgery | 
| PUFA Levels in Red Blood Cells Pre and Post Surgery | Analysis of variance (ANOVA) will be used to assess the effect of omega-3 dietary supplementation on PUFA levels separately in normal and malignant breast tissue. Analysis of covariance (ANCOVA) will be used to assess the omega-3 effect in plasma and red blood cells (RBC), where the baseline levels of the PUFAs will be included as covariates. PUFA Levels analyzed were 18:2 n-6, 18:3 n-3, 20:2 n-6, 20:4 n-6, 20:3 n-3, 20:5 n-3, 22:6 n-3 | Pre and post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | ANOVA will be used to assess the effect in normal and malignant breast tissue. Metabolites tested: PGE2, PGD2, 20-HETE, 5-HEPE, 13-HODE, 9-HODE, 15-HETE, 12-HETE, 5-HETE. | At time of surgery | 
| Number of Days to Establish Difference in Proliferation in Malignant Breast Tissue | ANOVA will be used to assess the effect of the supplementation in malignant breast tissue with less proliferation in malignant breast tissue in comparison to women who took the placebo. | At time of surgery | 
| Number of Days to Establish Increased Apoptosis in Malignant Breast Tissue | ANOVA will be used to assess the effect of the supplementation in malignant breast tissue with greater apoptosis in malignant breast tissue in comparison to women who took the placebo. | At time of surgery |