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

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ClinicalTrials.gov Identifier: NCT01869764
Recruitment Status : Completed
First Posted : June 5, 2013
Results First Posted : October 30, 2019
Last Update Posted : October 30, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Tracking Information
First Submitted Date  ICMJE May 31, 2013
First Posted Date  ICMJE June 5, 2013
Results First Submitted Date  ICMJE August 1, 2019
Results First Posted Date  ICMJE October 30, 2019
Last Update Posted Date October 30, 2019
Actual Study Start Date  ICMJE November 2013
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2019)
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: June 4, 2013)
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.
Change History Complete list of historical versions of study NCT01869764 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2019)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2013)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Omega-3 Fatty Acid in Treating Patients With Stage I-III Breast Cancer
Official Title  ICMJE A Randomized, Placebo-Controlled Phase II Clinical Trial of Omega-3 PUFA Dietary Supplementation in Patients With Stage I-III Breast Carcinoma
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Drug: omega-3 fatty acid
    Given PO
    Other Names:
    • fish oil
    • n-3 fatty acid
    • O3FA
  • Other: placebo
    Given PO
    Other Name: PLCB
  • Other: laboratory biomarker analysis
    Correlative studies
Study Arms  ICMJE
  • Experimental: Arm I (omega-3 fatty acid)
    Patients receive omega-3 fatty acid PO daily for 7-14 days.
    Interventions:
    • Drug: omega-3 fatty acid
    • Other: laboratory biomarker analysis
  • Placebo Comparator: Arm II (placebo)
    Patients receive placebo PO daily for 7-14 days.
    Interventions:
    • Other: placebo
    • Other: laboratory biomarker analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 1, 2018)
57
Original Estimated Enrollment  ICMJE
 (submitted: June 4, 2013)
60
Actual Study Completion Date  ICMJE July 2018
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01869764
Other Study ID Numbers  ICMJE IRB00023419
NCI-2013-00963 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA012197 ( U.S. NIH Grant/Contract )
CCCWFU 98113 ( Other Identifier: NCI )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wake Forest University Health Sciences
Study Sponsor  ICMJE Wake Forest University Health Sciences
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Edward Levine, MD Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP