<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02217033</url>
  </required_header>
  <id_info>
    <org_study_id>R822662</org_study_id>
    <nct_id>NCT02217033</nct_id>
  </id_info>
  <brief_title>Effects of 'R' (Electro-kinetic Beverage) on Insomnia, Fatigue, and Depression in Breast Cancer Patients Having Adjuvant Chemo</brief_title>
  <official_title>A Pilot Study Evaluating the Effect of 'R' (Electro-Kinetically Altered Beverage) on Insomnia, Fatigue and Depression in Breast Cancer Patients Receiving Adjuvant Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>South Sound Care Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>South Sound Care Foundation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effects of consuming &quot;R&quot; on quality of life in&#xD;
      the areas of insomnia, fatigue, and depression in female breast cancer patients receiving&#xD;
      multi-cycle adjuvant chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Female breast cancer patients eligible for adjuvant therapy with four cycles of Taxotere and&#xD;
      Cytoxan chemotherapy after surgery will be enrolled for the study.&#xD;
&#xD;
      Eligible subjects will begin to consume either &quot;R&quot; or purified water (placebo) just prior to&#xD;
      the 1st cycle of chemotherapy. Subjects will continue to consume either &quot;R&quot; or placebo&#xD;
      through Cycle 1, Cycle 2, Cycle 3, Cycle 4, and for an additional 12 weeks after completing&#xD;
      chemotherapy.&#xD;
&#xD;
      Study procedures will include clinical lab assessments, analysis of inflammatory markers, RNA&#xD;
      biomarkers, adverse events, subject diary, and quality of life measurements for insomnia,&#xD;
      fatigue and depression.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    After an interim analysis the Company providing the product decided not to continue with the&#xD;
    study&#xD;
  </why_stopped>
  <start_date type="Actual">January 2013</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The effects of consuming &quot;R&quot; on quality of life in the areas of insomnia in breast cancer patients receiving multi-cycle adjuvant chemotherapy</measure>
    <time_frame>Patients will be followed for up to 25 weeks</time_frame>
    <description>SleepMed Insomnia Questionnaire: This is a test to assess, in general, how a subject is feeling about their sleep using a &quot;0-4&quot; point scale - with the &quot;0&quot; representing no problem with sleep and &quot;4&quot; representing a big problem with how a subject feels about the quality of their sleep.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The effects of consuming &quot;R&quot; on quality of life in the areas of fatigue in breast cancer patients receiving multi-cycle adjuvant chemotherapy</measure>
    <time_frame>Patients will be followed for up to 25 weeks</time_frame>
    <description>FACIT Fatigue Scale: A list of questions that asks a patient how fatigued they have felt in the last 7 days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The effects of consuming &quot;R&quot; on quality of life in the areas of depression in breast cancer patients receiving multi-cycle adjuvant chemotherapy</measure>
    <time_frame>Patients will be followed for up to 25 weeks</time_frame>
    <description>Beck Depression Inventory-II: A list of statements that ask a subject about the way they have been feeling for the last two weeks.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Purified Water</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>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.&#xD;
Subjects will consume a specific volume based on the following weight categories: &lt;150 lb = 2 bottles/day; ≥150 lb and &lt;225 lb = 3 bottles/day; ≥225 lb = 4 bottles/day. Subjects will consume placebo for a minimum of 168 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>'R' (Electro-kinetically altered beverage)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized to this arm will begin to consume &quot;R&quot; (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.&#xD;
Subjects will consume a specific volume based on the following weight categories: &lt;150 lb = 2 bottles/day; ≥150 lb and &lt;225 lb = 3 bottles/day; ≥225 lb = 4 bottles/day. Subjects will consume R for a minimum of 168 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>'R' (Electro-kinetically altered beverage)</intervention_name>
    <arm_group_label>'R' (Electro-kinetically altered beverage)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo (water)</intervention_name>
    <arm_group_label>Purified Water</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female, non-smokers ≥ 18 years of age&#xD;
&#xD;
          -  Histologically or cytologically confirmed diagnosis of Stage I or II adenocarcinoma of&#xD;
             the breast and a candidate for adjuvant chemotherapy&#xD;
&#xD;
          -  Scheduled to receive 4 cycles of adjuvant Taxotere and Cytoxan chemotherapy (TC):&#xD;
             docetaxel 75 mg/m2 and cyclophosphamide 600 mg/m2 administered intravenously on Day 1&#xD;
             of each 21-day cycle&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group Status (ECOG) performance status of ≤ 1&#xD;
&#xD;
          -  No prior treatment for breast cancer other than surgery&#xD;
&#xD;
          -  Adequate baseline organ function as evidenced by:&#xD;
&#xD;
               -  Hemoglobin ≥ 9 g/dL&#xD;
&#xD;
               -  Absolute neutrophil count ≥ 1.5 x 109 cells/mm3&#xD;
&#xD;
               -  Platelet count ≥ 100,000 cells/mm3&#xD;
&#xD;
               -  Serum creatinine ≤ 1.5 x upper limit of normal (ULN)&#xD;
&#xD;
               -  Alkaline phosphatase ≤ 1.5 x ULN&#xD;
&#xD;
          -  No history of other malignancies within the last 5 years, except for carcinoma in situ&#xD;
             of the cervix, or basal cell carcinoma or squamous cell carcinoma of the skin that&#xD;
             have been previously treated with curative intent&#xD;
&#xD;
          -  Women of childbearing potential who commit to using two forms of highly effective&#xD;
             non-hormonal contraception either by the subject and/or partner during the study&#xD;
&#xD;
          -  Negative urine pregnancy test at screening&#xD;
&#xD;
          -  Negative urine drug screen (UDS) for drugs of abuse including cotinine (nicotine) at&#xD;
             screening&#xD;
&#xD;
          -  Subjects must be capable of understanding the purpose and risks of the study and&#xD;
             provide written, voluntary informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Preexisting diagnosed psychiatric disorder as defined by The Diagnostic and&#xD;
             Statistical Manual (DSM) of Mental Disorders (published by the American Psychiatric&#xD;
             Association). Subjects with a diagnosis of depression will be allowed to enter into&#xD;
             study as long as they have been treated with medication for ≥ 6 months and/or&#xD;
             depression is considered to be well controlled&#xD;
&#xD;
          -  Pregnant or lactating&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Concomitant use of any sleeping agents during the course of the study (Anti- anxiety&#xD;
             medications will be allowed)&#xD;
&#xD;
          -  Steroid therapy other than the standard prescribed therapy of either of the following&#xD;
             during the course of the study:&#xD;
&#xD;
               -  Dexamethasone 4-12 mg IV on Day 1 of any cycle&#xD;
&#xD;
               -  Dexamethasone 4-12 mg PO on Day 2 and Day 3 of any cycle&#xD;
&#xD;
          -  Anti-estrogen therapy other than the standard prescribed therapy of one of the&#xD;
             following:&#xD;
&#xD;
               -  Tamoxifen/Nolvadex 20 mg PO daily&#xD;
&#xD;
               -  Anastrazole/Arimidex 1 mg PO daily&#xD;
&#xD;
               -  Letrozole/Femara 2.5 mg PO daily&#xD;
&#xD;
               -  Exemestane/Aromasin 25 mg PO daily&#xD;
&#xD;
          -  Use of any other antiemetic regimen other than the following (with the exception of PO&#xD;
             antiemetics):&#xD;
&#xD;
               -  Emend /Aprepitant150 mg IV on Day 1 of any cycle&#xD;
&#xD;
               -  Aloxi/Palonosetron 0.25 mg IV on Day 1 of any cycle&#xD;
&#xD;
               -  Dexamethasone 8 mg IV on Day 1 of any cycle&#xD;
&#xD;
               -  Dexamethasone 8 mg PO on Day 2 and Day 3 of any cycle&#xD;
&#xD;
               -  Zofran/Ondansetron 12 mg IV on Day 1 of any cycle&#xD;
&#xD;
               -  Kytrile/Granisetron 1-2 mg IV on Day 1 of any cycle&#xD;
&#xD;
          -  Therapy with any immunomodulatory or immunosuppressive drugs within 6 months prior to&#xD;
             enrollment&#xD;
&#xD;
          -  Known history of positive viral serology test for Human Immunodeficiency Virus&#xD;
             (HIV-1), HBsAG and Hepatitis C antibody&#xD;
&#xD;
          -  Any change in the initially prescribed chemotherapy&#xD;
&#xD;
          -  Use of herbal remedies, dietary supplements or mega-vitamins, with the exception of a&#xD;
             multi-vitamin&#xD;
&#xD;
          -  Investigator deems the subject to be unable or unwilling to comply with the&#xD;
             requirements of the protocol&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Francis (Frank) Senecal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwest Medical Specialties</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NWMS Bonney Lake - Medical Oncology</name>
      <address>
        <city>Bonney Lake</city>
        <state>Washington</state>
        <zip>98391</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NWMS Federal Way - Medical Oncology</name>
      <address>
        <city>Federal Way</city>
        <state>Washington</state>
        <zip>98003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NWMS Gig Harbor - Medical Oncology</name>
      <address>
        <city>Gig Harbor</city>
        <state>Washington</state>
        <zip>98332</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NWMS Lakewood - Medical Oncology</name>
      <address>
        <city>Lakewood</city>
        <state>Washington</state>
        <zip>98499</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rainier Hematology-Oncology, WA</name>
      <address>
        <city>Puyallup</city>
        <state>Washington</state>
        <zip>98373</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NWMS Tacoma - Medical Oncology &amp; Infectious Diseases</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>April 17, 2017</last_update_submitted>
  <last_update_submitted_qc>April 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>South Sound Care Foundation</investigator_affiliation>
    <investigator_full_name>Francis (Frank) Senecal, MD</investigator_full_name>
    <investigator_title>Site Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Breast Cancer</keyword>
  <keyword>Stage I breast cancer</keyword>
  <keyword>Stage II breast cancer</keyword>
  <keyword>Water study</keyword>
  <keyword>'R'</keyword>
  <keyword>Electro-kinetically altered beverage</keyword>
  <keyword>altered beverage</keyword>
  <keyword>Insomnia</keyword>
  <keyword>Fatigue</keyword>
  <keyword>Depression</keyword>
  <keyword>Adjuvant chemotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
    <mesh_term>Fatigue</mesh_term>
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02217033
org study id: R822662
nct id: NCT02217033
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: 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
description: 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.
measure: 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
description: FACIT Fatigue Scale: A list of questions that asks a patient how fatigued they have felt in the last 7 days.
measure: 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
description: Beck Depression Inventory-II: A list of statements that ask a subject about the way they have been feeling for the last two weeks.
arm group label: Purified Water
arm group type: Placebo Comparator
description: 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.
arm group label: 'R' (Electro-kinetically altered beverage)
arm group type: Experimental
description: 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.
intervention type: Other
intervention name: 'R' (Electro-kinetically altered beverage)
arm group label: 'R' (Electro-kinetically altered beverage)
intervention type: Other
intervention name: Placebo (water)
arm group label: Purified Water
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Francis (Frank) Senecal, MD
role: Principal Investigator
affiliation: Northwest Medical Specialties
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: South Sound Care Foundation
investigator full name: Francis (Frank) Senecal, MD
investigator title: Site Principal Investigator
mesh term: Breast Neoplasms
mesh term: Sleep Initiation and Maintenance Disorders
mesh term: Fatigue
mesh term: Depression