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

Protocol
12-267
Full Title
A Multicenter Phase II Study of Docosahexaenoic Acid (DHA) in Patients with a History of Breast Cancer, Premalignant Lesions, or Benign Breast Disease
Phase
II
Purpose

Obesity can increase the risk of breast cancer by causing breast inflammation, which has been linked to cancer. The purpose of this study is to see if treatment with docosahexaenoic acid (DHA) in overweight and obese women with a history of breast cancer, premalignant lesions, or benign breast disease reduces the amount of inflammation in the breast. If the effects are significant, it might be possible to use DHA to reduce the risk of breast cancer development and recurrence.

DHA is a fatty acid that is present in some foods (such as fatty fish) and in fish oil supplements. DHA is known to inhibit cancer-fueling chemicals produced by certain immune cells that accumulate in inflamed breast tissue. It is not yet known if DHA can reduce the risk of breast cancer.

Participants in this study will be randomly assigned to receive either DHA capsules or placebo (sugar) capsules. Researchers will compare the levels of certain “biomarkers” of inflammation in the blood and breast tissue in both groups.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a history of breast cancer, premalignant lesions, or benign breast disease.
  • The minimum body mass index (BMI) for participants must be 25. BMI is a measure of body fat based on height and weight. A BMI of 25 to 29.9 is considered overweight, while a BMI of 30 or more is considered obese.
  • Because breast tissue for analysis will be taken (via needle biopsy) from a breast that has not been treated with radiation therapy, women who had cancer in both breasts may not participate.
  • Patients will need to stop taking daily aspirin, other non-steroidal anti-inflammatory agents (such as ibuprofen or naproxen), or DHA (less than 200 mg/day) at least one week before entering the study.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • This study is open to women age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Ayca Gucalp at 646-888-4538.

Disease(s)
Breast Cancer
Survivorship
Locations
Related Diseases