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Randomized Multicenter Phase II Study of Docosahexaenoic Acid (DHA) in Patients with a History of Breast Cancer, Premalignant Lesions, or Benign Breast Disease

Results/Findings:

Baseline levels of TNFα, IL1β, COX-2, and aromatase mRNAs did not differ significantly between the two treatment groups. The changes in the levels of TNFα (P = 0.50), IL1β (P = 0.52), COX-2 (P = 0.19), and aromatase (P = 0.12) after 12 weeks of treatment did not differ significantly between the two groups in the ITT cohort. Furthermore, in the preplanned evaluable population, there was also no statistically significant difference between the two arms in the change in pre- versus post-treatment levels in the tissue biomarker endpoints.

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