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NCT Number: NCT01869764

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

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.

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Key information

Conditions

Ductal Breast Carcinoma In Situ Adenocarcinoma Breast Carcinoma In Situ Breast Diseases Breast Neoplasms Breast Neoplasms, Male Carcinoma Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Lobular Breast Carcinoma in Situ Male Breast Cancer Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases Stage IA Breast Cancer Stage IB Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

omega-3 fatty acid

Drug

Given PO

Other names: fish oil, n-3 fatty acid, O3FA

Placebo

Other

Given PO

Other names: PLCB

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

  1. PUFA Levels in Normal and Metastatic Breast Tissue

    Time frame: 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

  2. PUFA Levels in Plasma Pre and Post Surgery

    Time frame: 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

  3. PUFA Levels in Red Blood Cells Pre and Post Surgery

    Time frame: 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 outcomes

  1. Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue

    Time frame: 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.

  2. Number of Days to Establish Difference in Proliferation in Malignant Breast Tissue

    Time frame: 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.

  3. Number of Days to Establish Increased Apoptosis in Malignant Breast Tissue

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jun 5, 2013
Registry last updated
Oct 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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