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


Phase 2
18 Years
N/A
Not Enrolling
Both
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

Thank you

Trial Information

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


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.


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:

- Use of any corticosteroid or nonsteroidal anti-inflammatory drug (NSAID) for 2 weeks
prior to study enrollment

- 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 between biopsy and surgery

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PUFA levels in normal and metastatic breast tissue and in plasma and red blood cells

Outcome Description:

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.

Outcome Time Frame:

At time of surgery

Safety Issue:

No

Principal Investigator

Julia Lawrence

Investigator Role:

Principal Investigator

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CCCWFU 98113

NCT ID:

NCT01869764

Start Date:

June 2013

Completion Date:

Related Keywords:

  • 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
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma in Situ
  • Carcinoma, Intraductal, Noninfiltrating
  • Carcinoma, Ductal, Breast
  • Carcinoma, Lobular
  • Breast Neoplasms, Male

Name

Location
Comprehensive Cancer Center of Wake Forest University Winston-Salem, North Carolina  27157-1082