Trial Information

Omega-3 Fatty Acids and Prevention of DCIS and/or ADH: A Translational Approach

OBJECTIVES:

- To determine the effect of omega-3 fatty acids on markers of breast cancer progression
in women with newly diagnosed ductal carcinoma in situ and/or atypical ductal
hyperplasia.

- To determine the effect of omega-3 fatty acids on specific targets identified by
microarray in breast cancer cells and in primary cultures from benign and malignant
breast tissue biopsies.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral omega-3 fatty acid capsules 3 times daily for up to 8
weeks.

- Arm II: Patients receive oral placebo olive oil capsules 3 times daily for up to 8
weeks.

Patients complete questionnaires at baseline, weekly during study treatment, at the
completion of study treatment, and then at 30 days after completion of study treatment.
These questionnaires include the Fish Oil Adverse Event Questionnaire, the Diet and Family
History Questionnaire, the Changes to Diet and Medications Questionnaire, and the
Post-Intervention Questionnaire.

Patients undergo blood, urine, nipple aspirate, and tissue sample collection at baseline and
after completion of study treatment for translational research studies. Blood samples are
analyzed for genetic markers for breast cancer risk and progression by microarray analysis
and RBC fatty acids. Nipple aspirate samples are analyzed for fatty acids to determine the
extent to which omega-3 fatty acid supplementation alters the fatty acid profile of breast
tissue. Tissue samples are analyzed for the presence of ductal carcinoma in situ and/or
atypical ductal hyperplasia or invasive cancer. Leftover blood, urine, nipple aspirate, and
tissue samples are stored for future research studies.

After completion of study treatment, patients are followed at 30 days.