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

Phase 2

Completed

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

Interventions: Other: placebo
Drug: omega-3 fatty acid
Other: laboratory biomarker analysis

Registration Number: NCT01869764

Lead Sponsor: Wake Forest University Health Sciences

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 57

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II (placebo)	laboratory biomarker analysis	Patients receive placebo PO daily for 7-14 days.
Arm II (placebo)	placebo	Patients receive placebo PO daily for 7-14 days.
Arm I (omega-3 fatty acid)	laboratory biomarker analysis	Patients receive omega-3 fatty acid PO daily for 7-14 days.
Arm I (omega-3 fatty acid)	omega-3 fatty acid	Patients receive omega-3 fatty acid PO daily for 7-14 days.

Primary Outcome Measures

Name	Time	Method
PUFA Levels in Normal and Metastatic Breast Tissue	At time of 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
PUFA Levels in Plasma Pre and Post Surgery	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
PUFA Levels in Red Blood Cells Pre and Post Surgery	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

Secondary Outcome Measures

Name	Time	Method
Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue	At time of surgery	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.
Number of Days to Establish Difference in Proliferation in Malignant Breast Tissue	At time of surgery	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.
Number of Days to Establish Increased Apoptosis in Malignant Breast Tissue	At time of surgery	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.