- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02217033
Effects of 'R' (Electro-kinetic Beverage) on Insomnia, Fatigue, and Depression in Breast Cancer Patients Having Adjuvant Chemo
A Pilot Study Evaluating the Effect of 'R' (Electro-Kinetically Altered Beverage) on Insomnia, Fatigue and Depression in Breast Cancer Patients Receiving Adjuvant Chemotherapy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Washington
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Bonney Lake, Washington, United States, 98391
- NWMS Bonney Lake - Medical Oncology
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Federal Way, Washington, United States, 98003
- NWMS Federal Way - Medical Oncology
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Gig Harbor, Washington, United States, 98332
- NWMS Gig Harbor - Medical Oncology
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Lakewood, Washington, United States, 98499
- NWMS Lakewood - Medical Oncology
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Puyallup, Washington, United States, 98373
- Rainier Hematology-Oncology, WA
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Tacoma, Washington, United States, 98405
- NWMS Tacoma - Medical Oncology & Infectious Diseases
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Purified Water
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. |
|
Experimental: 'R' (Electro-kinetically altered beverage)
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The effects of consuming "R" on quality of life in the areas of insomnia in breast cancer patients receiving multi-cycle adjuvant chemotherapy
Time Frame: Patients will be followed for up to 25 weeks
|
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
Time Frame: Patients will be followed for up to 25 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The effects of consuming "R" on quality of life in the areas of depression in breast cancer patients receiving multi-cycle adjuvant chemotherapy
Time Frame: Patients will be followed for up to 25 weeks
|
Beck Depression Inventory-II: A list of statements that ask a subject about the way they have been feeling for the last two weeks.
|
Patients will be followed for up to 25 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Francis (Frank) Senecal, MD, Northwest Medical Specialties
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R822662
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
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Innocrin PharmaceuticalCompletedBreast Cancer | Advanced Breast Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | Male Breast Cancer | ER+ Breast Cancer | Cancer of the BreastUnited States
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University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
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CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
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University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
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University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
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University of Southern CaliforniaNational Cancer Institute (NCI)WithdrawnStage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer
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