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Omega 3 Fatty Acid

No dietary energy restriction plus Placebo

Placebo

Lovaza

Dietary energy restriction

Andrea Manni, MD

The over-reaching goal of this study is to test the merit of combining dietary energy restriction with omega-3 fatty acids as a safe and effective breast cancer chemoprevention strategy in overweight and obese women at high risk.

Obesity over the pre- and postmenopausal years is linked to the risk of postmenopausal breast cancer. Multiple mechanisms are likely to contribute to obesity associated breast cancer risk. They include increased insulin like growth factor (IGF)-I bioavailability, oxidative stress, raised leptin to adiponectin ratio, and increased inflammatory cytokines which are responsible for the creation of a systemic and local hyperestrogenic milieu by induction of aromatase and may also be responsible for the reduction in antitumor immunity by stimulation of immunosuppressive cells. While derivative chromosome disulfiram (DER) has been shown to reverse some of these obesity related phenotypic features, it is not yet established whether DER reduces breast cancer risk using validated tissue biomarkers predictive of breast cancer development. N:3FA (3-fatty acids) have been shown to ameliorate obesity-induced effects on circulating leptin and adiponectin, insulin resistance, endogenous estrogen production and inflammation. Although preclinical studies have indicated a protective effect of n:3FA on mammary carcinogenesis, the data in humans are inconclusive, likely as a result of the lack of controlled clinical trials. Investigators hypothesize that the combination of DER and n:3FA will reduce breast cancer risk in an additive/synergistic fashion through their complementary effects on the multiple inter-related pathways accounting for the obesity associated breast cancer risk. Investigators propose to conduct a clinical trial study involving overweight and obese women between the ages of 30 and 55 who are at high risk of breast cancer and are found on random periareolar fine needle aspiration to have hyperplasia with or without atypia with Ki67 ≥2 if premenopausal and ≥1.5 if postmenopausal. Following stratification according to menopausal status they will be randomized to one of four experimental groups.

Dietary Energy Restriction and Omega-3 Fatty Acids on Mammary Tissue

Effect of Dietary Energy Restriction and Omega-3 Fatty Acids on Mammary Tissue and Systemic Biomarkers of Breast Cancer Risk

Ki67 expression by hyperplastic breast lesions

Milton S. Hershey Medical Center

Professor and Chief, Division of Endocrinology, Diabetes and Metabolism

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Dietary Energy Restriction and Omega-3 Fatty Acids on Mammary Tissue	NCT01784042	Breast Cancer	Placebo Lovaza Dietary energy ...	30 Years - 55 Years	Milton S. Hershey Medical Center
Dietary Energy Restriction and Omega-3 Fatty Acids on Mammary Tissue	NCT01784042	Breast Cancer	Placebo Lovaza Dietary energy ...	30 Years - 55 Years	Milton S. Hershey Medical Center

Spots Global Cancer Trial Database for dietary energy restriction