Clinical Trials

A Phase II Study of Docosahexaenoic Acid (DHA) in Survivors of Triple-Negative Breast Cancer

Protocol
12-267
Full Title
A Multicenter Phase II Study of Docosahexaenoic Acid (DHA) in Triple Negative Breast Cancer Survivors
Purpose

Triple-negative breast cancers lack the presence of the estrogen receptor, progesterone receptor, and HER2/NEU protein. This subtype of breast cancer can be aggressive, difficult to treat, and more likely to recur than other subtypes of breast cancer. 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 survivors of triple-negative breast cancer for six months 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.

Investigator
Clifford A. Hudis, MD -- Chief, Breast Cancer Medicine Service
Clifford A. Hudis - Physician Profile
Co-Investigators
Pictured: Ayca Gucalp
Ayca Gucalp - Physician Profile
Eligibility

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

  • Patients must have completed treatment for stage I-III triple-negative breast cancer six or more months before entering the study and have no evidence of 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 month before entering the study. Individuals who are actively taking statin (cholesterol) drugs or steroids/immune-modulating drugs may not participate.
  • 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