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

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast Cancer, Stage I breast cancer, Stage II breast cancer, Water study, 'R', Electro-kinetically altered beverage, altered beverage, Insomnia, Fatigue, Depression, Adjuvant chemotherapy Read More

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