Clinical trial NCT01869764: Omega-3 Fatty Acid in Treating Patients With Stage I-III Breast Cancer
Official title: A Randomized, Placebo-Controlled Phase II Clinical Trial of Omega-3 PUFA Dietary Supplementation in Patients With Stage I-III Breast Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-06-05
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: PUFA Levels in Normal and Metastatic Breast Tissue
timeFrame: At time of surgery
measure: PUFA Levels in Plasma Pre and Post Surgery
timeFrame: Pre and post surgery
measure: PUFA Levels in Red Blood Cells Pre and Post Surgery
timeFrame: Pre and post surgery
Secondary outcomes:
measure: Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue
timeFrame: At time of surgery
measure: Number of Days to Establish Difference in Proliferation in Malignant Breast Tissue
timeFrame: At time of surgery
measure: Number of Days to Establish Increased Apoptosis in Malignant Breast Tissue
timeFrame: At time of surgery
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Edward Levine, MD
role: PRINCIPAL_INVESTIGATOR
References: