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

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Wake Forest University Health Sciences
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT01869764
First received: May 31, 2013
Last updated: May 30, 2017
Last verified: May 2017
  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
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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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 Wake Forest University Health Sciences:

Primary Outcome Measures:
  • PUFA levels in normal and metastatic breast tissue and in plasma and red blood cells [ 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.


Secondary Outcome Measures:
  • 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.

  • Proliferation and apoptosis in malignant breast tissue [ Time Frame: At time of surgery ]
    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 2017 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Edward Levine, MD 336-713-6927 stalewis@wakehealth.edu

Locations
United States, North Carolina
Comprehensive Cancer Center of Wake Forest University Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Greg Kucera, PhD    336-716-6348    gkucera@wakehealth.edu   
Principal Investigator: Greg Kucera, PhD         
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
Principal Investigator: Edward Levine, MD Wake Forest University Health Sciences
  More Information

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01869764     History of Changes
Other Study ID Numbers: CCCWFU 98113
NCI-2013-00963 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA012197 ( U.S. NIH Grant/Contract )
Study First Received: May 31, 2013
Last Updated: May 30, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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

ClinicalTrials.gov processed this record on July 24, 2017