Effects of 'R' (Electro-kinetic Beverage) on Insomnia, Fatigue, and Depression in Breast Cancer Patients Having Adjuvant Chemo

Female breast cancer patients eligible for adjuvant therapy with four cycles of Taxotere and
Cytoxan chemotherapy after surgery will be enrolled for the study.

Eligible subjects will begin to consume either "R" or purified water (placebo) just prior to
the 1st cycle of chemotherapy. Subjects will continue to consume either "R" or placebo
through Cycle 1, Cycle 2, Cycle 3, Cycle 4, and for an additional 12 weeks after completing
chemotherapy.

Study procedures will include clinical lab assessments, analysis of inflammatory markers,
RNA biomarkers, adverse events, subject diary, and quality of life measurements for
insomnia, fatigue and depression.

Inclusion Criteria:

- Female, non-smokers ≥ 18 years of age

- Histologically or cytologically confirmed diagnosis of Stage I or II adenocarcinoma
of the breast and a candidate for adjuvant chemotherapy

- Scheduled to receive 4 cycles of adjuvant Taxotere and Cytoxan chemotherapy (TC):
docetaxel 75 mg/m2 and cyclophosphamide 600 mg/m2 administered intravenously on Day 1
of each 21-day cycle

- Eastern Cooperative Oncology Group Status (ECOG) performance status of ≤ 1

- No prior treatment for breast cancer other than surgery

- Adequate baseline organ function as evidenced by:

- Hemoglobin ≥ 9 g/dL

- Absolute neutrophil count ≥ 1.5 x 109 cells/mm3

- Platelet count ≥ 100,000 cells/mm3

- Serum creatinine ≤ 1.5 x upper limit of normal (ULN)

- Alkaline phosphatase ≤ 1.5 x ULN

- No history of other malignancies within the last 5 years, except for carcinoma in
situ of the cervix, or basal cell carcinoma or squamous cell carcinoma of the skin
that have been previously treated with curative intent

- Women of childbearing potential who commit to using two forms of highly effective
non-hormonal contraception either by the subject and/or partner during the study

- Negative urine pregnancy test at screening

- Negative urine drug screen (UDS) for drugs of abuse including cotinine (nicotine) at
screening

- Subjects must be capable of understanding the purpose and risks of the study and
provide written, voluntary informed consent

Exclusion Criteria:

- Preexisting diagnosed psychiatric disorder as defined by The Diagnostic and
Statistical Manual (DSM) of Mental Disorders (published by the American Psychiatric
Association). Subjects with a diagnosis of depression will be allowed to enter into
study as long as they have been treated with medication for ≥ 6 months and/or
depression is considered to be well controlled

- Pregnant or lactating

- Diabetes

- Concomitant use of any sleeping agents during the course of the study (Anti- anxiety
medications will be allowed)

- Steroid therapy other than the standard prescribed therapy of either of the following
during the course of the study:

- Dexamethasone 4-12 mg IV on Day 1 of any cycle

- Dexamethasone 4-12 mg PO on Day 2 and Day 3 of any cycle

- Anti-estrogen therapy other than the standard prescribed therapy of one of the
following:

- Tamoxifen/Nolvadex 20 mg PO daily

- Anastrazole/Arimidex 1 mg PO daily

- Letrozole/Femara 2.5 mg PO daily

- Exemestane/Aromasin 25 mg PO daily

- Use of any other antiemetic regimen other than the following (with the exception of
PO antiemetics):

- Emend /Aprepitant150 mg IV on Day 1 of any cycle

- Aloxi/Palonosetron 0.25 mg IV on Day 1 of any cycle

- Dexamethasone 8 mg IV on Day 1 of any cycle

- Dexamethasone 8 mg PO on Day 2 and Day 3 of any cycle

- Zofran/Ondansetron 12 mg IV on Day 1 of any cycle

- Kytrile/Granisetron 1-2 mg IV on Day 1 of any cycle

- Therapy with any immunomodulatory or immunosuppressive drugs within 6 months prior to
enrollment

- Known history of positive viral serology test for Human Immunodeficiency Virus
(HIV-1), HBsAG and Hepatitis C antibody

- Any change in the initially prescribed chemotherapy

- Use of herbal remedies, dietary supplements or mega-vitamins, with the exception of a
multi-vitamin

- Investigator deems the subject to be unable or unwilling to comply with the
requirements of the protocol