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

NCT02217033 | Terminated

• 1 other identifier: R822662
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to evaluate the effects of consuming "R" on quality of life in the areas of insomnia, fatigue, and depression in female breast cancer patients receiving multi-cycle adjuvant chemotherapy.

Conditions

Breast Cancer

Keywords

Breast Cancer; Stage I breast cancer; Stage II breast cancer; Water study; 'R'; Electro-kinetically altered beverage; altered beverage; Insomnia; Fatigue; Depression; Adjuvant chemotherapy

Outcome Measures

Primary Outcomes (2)

• The effects of consuming "R" on quality of life in the areas of insomnia in breast cancer patients receiving multi-cycle adjuvant chemotherapy

  SleepMed Insomnia Questionnaire: This is a test to assess, in general, how a subject is feeling about their sleep using a "0-4" point scale - with the "0" representing no problem with sleep and "4" representing a big problem with how a subject feels about the quality of their sleep.

  Patients will be followed for up to 25 weeks

• The effects of consuming "R" on quality of life in the areas of fatigue in breast cancer patients receiving multi-cycle adjuvant chemotherapy

  FACIT Fatigue Scale: A list of questions that asks a patient how fatigued they have felt in the last 7 days.

  Patients will be followed for up to 25 weeks

Secondary Outcomes (1)

• The effects of consuming "R" on quality of life in the areas of depression in breast cancer patients receiving multi-cycle adjuvant chemotherapy

  Patients will be followed for up to 25 weeks

Study Arms (2)

Purified Water

PLACEBO COMPARATOR

In this arm, eligible subjects will begin to consume purified water (placebo) just prior to the 1st cycle of chemotherapy. Subjects will continue to consume the placebo through their chemotherapy and then for an additional 12 weeks after completing chemotherapy. Subjects will consume a specific volume based on the following weight categories: \<150 lb = 2 bottles/day; ≥150 lb and \<225 lb = 3 bottles/day; ≥225 lb = 4 bottles/day. Subjects will consume placebo for a minimum of 168 days.

Other: Placebo (water)

'R' (Electro-kinetically altered beverage)

EXPERIMENTAL

Patients randomized to this arm will begin to consume "R" (Electro-kinetically altered beverage) just prior to the 1st cycle of chemotherapy and continue it through their chemotherapy cycles and then for an additional 12 weeks after completing chemotherapy. Subjects will consume a specific volume based on the following weight categories: \<150 lb = 2 bottles/day; ≥150 lb and \<225 lb = 3 bottles/day; ≥225 lb = 4 bottles/day. Subjects will consume R for a minimum of 168 days.

Other: 'R' (Electro-kinetically altered beverage)

Interventions

'R' (Electro-kinetically altered beverage) OTHER

'R' (Electro-kinetically altered beverage)

Placebo (water) OTHER

Purified Water

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• South Sound Care Foundation: lead

Study Sites (6)

NWMS Bonney Lake - Medical Oncology

Bonney Lake, Washington, 98391, United States

Location

NWMS Federal Way - Medical Oncology

Federal Way, Washington, 98003, United States

Location

NWMS Gig Harbor - Medical Oncology

Gig Harbor, Washington, 98332, United States

Location

NWMS Lakewood - Medical Oncology

Lakewood, Washington, 98499, United States

Location

Rainier Hematology-Oncology, WA

Puyallup, Washington, 98373, United States

Location

NWMS Tacoma - Medical Oncology & Infectious Diseases

Tacoma, Washington, 98405, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Sleep Initiation and Maintenance Disorders; Fatigue; Depression

Interventions

Water

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Francis (Frank) Senecal, MD

  Northwest Medical Specialties

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Site Principal Investigator

Study Record Dates

• First Submitted: August 8, 2014
• First Posted: August 15, 2014
• Study Start: January 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 18, 2017

Record last verified: 2017-04

Locations

US (6)