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