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

This study is currently recruiting participants.
Verified January 2014 by Comprehensive Cancer Center of Wake Forest University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01869764
First received: May 31, 2013
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Ductal Breast Carcinoma in Situ
Lobular Breast Carcinoma in Situ
Male Breast Cancer
Stage IA Breast Cancer
Stage IB Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Dietary Supplement: omega-3 fatty acid
Other: placebo
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled Phase II Clinical Trial of Omega-3 PUFA Dietary Supplementation in Patients With Stage I-III Breast Carcinoma

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • PUFA levels in normal and metastatic breast tissue and in plasma and red blood cells [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Metabolites of omega-3 and omega-6 PUFA in malignant and normal breast tissue [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]
    ANOVA will be used to assess the effect in normal and malignant breast tissue.

  • Proliferation and apoptosis in malignant breast tissue [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]
    ANOVA will be used to assess the effect in normal and malignant breast tissue.


Estimated Enrollment: 60
Study Start Date: November 2013
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (omega-3 fatty acid)
Patients receive omega-3 fatty acid PO daily for 7-14 days.
Dietary Supplement: omega-3 fatty acid
Given PO
Other Names:
  • fish oil
  • n-3 fatty acid
  • O3FA
Other: laboratory biomarker analysis
Correlative studies
Placebo Comparator: Arm II (placebo)
Patients receive placebo PO daily for 7-14 days.
Other: placebo
Given PO
Other Name: PLCB
Other: laboratory biomarker analysis
Correlative studies

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01869764

Locations
United States, North Carolina
Comprehensive Cancer Center of Wake Forest University Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Julia A. Lawrence    336-716-7975    jalawren@wakehealth.edu   
Principal Investigator: Julia A. Lawrence         
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Principal Investigator: Julia Lawrence Comprehensive Cancer Center of Wake Forest University
  More Information

No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT01869764     History of Changes
Other Study ID Numbers: CCCWFU 98113, NCI-2013-00963, P30CA012197
Study First Received: May 31, 2013
Last Updated: January 22, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Ductal, Breast
Carcinoma, Lobular
Breast Neoplasms, Male
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Carcinoma, Ductal

ClinicalTrials.gov processed this record on April 23, 2014