Docosahexaenoic Acid (DHA) To Prevent Development of Cognitive Dysfunction Due to Chemotherapy

Chemotherapy is often associated with problems of cognitive functioning such as decision
making, learning, and memory. These symptoms, collectively referred to here as cognitive
dysfunction can appear as early as the first few months after starting chemotherapy and may
persist long after chemotherapy and anti-hormone therapy, if any, is completed.

Once developed there is no satisfactory treatment for cognitive dysfunction although
cognitive retraining and exercise may improve symptoms and/or function; at least for some.

Omega-3 fatty acids derived from ocean fish are a new potential preventative treatment
against development of cognitive problems which can arise in some individuals during
chemotherapy treatment. In doses of 1-2 grams per day it has been found to improve some
aspects of cognitive function in healthy adults who have low DHA dietary intake. It has also
been shown to improve some aspects of function in individuals with a mild reduction in
cognitive ability but not for those with marked impairment.

Participation in this study will last about 12 months. Participants will make visits to the
study site for both standard of care visits and additional study-related visits. Participants
will be randomized (randomly assigned; like flipping a coin) to one of two groups. Neither
the Investigator nor the participant will know the assigned treatment.

Inclusion Criteria:

- Diagnosis of invasive breast cancer (Stage I-III) and are anticipated to start
neo-adjuvant chemotherapy (multiple chemotherapy regimens allowed under protocol)

- Able to read, write, and understand English and at least have a high school education.

- Able and willing to go at least 24-36 hours without narcotic pain medicine, muscle
relaxants, sedatives, sleeping pills and alcohol prior to their cognitive testing.
Participants should not have required chronic sedatives, sleeping aids, or narcotic
pain medications on a daily basis prior to their diagnosis.

- Willing to complete required study procedures from start of study to approximately 6
months after completion of neo-adjuvant chemotherapy.

Exclusion Criteria:

- Women who are currently on omega-3 fatty acid supplements with > 500 mg of EPA plus
DHA daily or 250 mg of DHA alone and or who have chronically been on more than 1 fish
oil capsule per day.

- Individuals who are not willing to stop fish or krill oil supplements during the
study.

- Diabetics requiring insulin treatment.

- Individuals who are not likely to be able to go for 24 hours without sleeping pills,
sedatives, narcotic pain medications, or ativan

- Individuals who do not have a high school education or are not fluent in English.

- Individuals who have already started chemotherapy for breast cancer or who have
previously had systemic chemotherapy for a malignancy.

- Women who have already had definitive surgery for breast cancer.