COGNUTRIN in Breast Cancer Survivors

This pilot study will evaluate the feasibility of administration of the nutritional
supplement and placebo in this patient population and performing cognitive function testing
at baseline and post supplementation.

This is a randomized, double-blind pilot study of COGNUTRIN vs. Placebo.

Participants have an equal chance (like flipping a coin) of being in either of the study
groups. Neither the participant nor the study doctor will be able to choose which study group
the participant is in. Participants will not know and the study doctor will not know which
study group the participants are in.

Inclusion Criteria:

- Cases with Stage II-IIIA Breast Cancer that have completed adjuvant treatment with
anthracyclines and/or taxanes + or -Radiation therapy within past 6 months(+/- 7 days)
(subjects on concurrent endocrine therapy (TAM, Aromatase inhibitors are also eligible
to participate as this is standard of care for this patient population)

- Able to understand and sign the informed consent

- Fluent in reading, comprehension and communication in the English language

- No evidence of dementia - Mini Mental State Examination (MMSE) >=23 but some evidence
of cognitive impairment

- Must be aware of the nature of his current medical condition and must be willing to
give consent after being informed of the experimental nature of therapy, alternatives,
potential benefits, side-effects, risks and discomforts

- Eastern Cooperative Oncology Group (ECOG) performance status of 0- 2 (Karnofsky score
>60%)

- Acceptable hemoglobin and hematocrit level based on complete blood count (CBC)

- Must be willing to be monitored for adequacy of nutritional intake during the
intervention, as is the current standard of clinical practice

Exclusion Criteria:

- Use of estrogens (oral, dermal or vaginal), progesterone (oral or topical), androgens,
Raloxifene or Tamoxifen during the previous 3 months

- Use of over the counter steroid hormonal supplements including dehydroepiandrosterone
(DHEA)

- Patients with advanced or Stage IIIIB or IV breast cancer or other cancers

- Use of n-3 fatty acids or high dose antioxidant supplements other than what is
provided in the trial

- History of known allergy to components of the study supplements

- Renal or liver disease

- Concurrent participation in another chemoprevention trial

- Evidence of bleeding diathesis or coagulopathy

- Metabolic abnormalities (e.g. thyroid disorders, insulin dependent diabetes,
rheumatologic disease etc.)

- Known claustrophobia, presence of pacemaker and/or ferromagnetic material in their
body that would prohibit MRI imaging

- Medical history of concussions

- Other acute or chronic medical or psychiatric condition or laboratory abnormality that
may increase risk associated with study participation or study drug administration, or
may interfere with interpretation of study results, and in the judgment of the
investigator would make the potential participant inappropriate for entry into this
study