A Randomized, Placebo-Controlled Phase II Clinical Trial of Omega-3 PUFA Dietary Supplementation in Patients With Stage I-III Breast Carcinoma
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
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
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
PUFA levels in normal and metastatic breast tissue and in plasma and red blood cells
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.
At time of surgery
Comprehensive Cancer Center of Wake Forest University
United States: Institutional Review Board
|Comprehensive Cancer Center of Wake Forest University||Winston-Salem, North Carolina 27157-1082|