<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/NCT01669460</url>
  </required_header>
  <id_info>
    <org_study_id>12-5041-C</org_study_id>
    <nct_id>NCT01669460</nct_id>
  </id_info>
  <brief_title>Study of Red Bull™ Sugar-Free Drink for Reduction of Fatigue in Prostate Cancer Patients Receiving LHRH Agonist Therapy</brief_title>
  <official_title>A Phase II, Open Label Study of Red Bull™ Sugar-Free Drink for Reduction of Fatigue in Prostate Cancer Patients Receiving LHRH Agonist Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Health Network, Toronto</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to find out if Red Bull™ Sugar-Free Drink can reduce&#xD;
      fatigue in prostate cancer patients receiving LHRH agonist therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <primary_completion_date type="Actual">July 2013</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction in overall fatigue as measured by Bruera global fatigue severity scale.</measure>
    <time_frame>Within 4 days after completion of intervention (28 days of Red Bull™)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall improvement in quality of life as measured by the Medical Outcomes Study Short-Form (SF-36)</measure>
    <time_frame>Within 4 days after completion of intervention (28 days of Red Bull™)</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Fatigue</condition>
  <arm_group>
    <arm_group_label>Red Bull™ Sugar-Free Drink</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Red Bull™ Sugar-Free Drink: two (250mL) cans per day for 28 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Red Bull™ Sugar-Free Drink</intervention_name>
    <description>Red Bull™ Sugar-Free Drink two (250mL) cans per day for 28 days</description>
    <arm_group_label>Red Bull™ Sugar-Free Drink</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed prostate cancer&#xD;
&#xD;
          -  Currently receiving LHRH-agonist therapy for greater than 6 months&#xD;
&#xD;
          -  Measurable fatigue, defined as a score of ≥ 2 on the Bruera global fatigue severity&#xD;
             scale&#xD;
&#xD;
          -  Able to swallow Red Bull™ Sugar-Free Drink&#xD;
&#xD;
          -  Life expectancy of at least 1 year&#xD;
&#xD;
          -  Able to read and write in English&#xD;
&#xD;
          -  Willing to limit consumption of alcohol to one drink per day&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current malignancy or received treatment for a previous malignancy within the last 3&#xD;
             years other than prostate cancer (exceptions are superficial bladder cancer or&#xD;
             non-melanoma skin cancer)&#xD;
&#xD;
          -  Myocardial infarction within past 6 months&#xD;
&#xD;
          -  Any unstable serious co-existing medical condition(s) including but not limited to&#xD;
             unstable or poorly controlled coronary artery disease, chronic atrial fibrillation,&#xD;
             uncontrolled hypertension, uncontrolled diabetes, severe bleeding diseases or immune&#xD;
             disorders&#xD;
&#xD;
          -  Evidence of drug or alcohol abuse&#xD;
&#xD;
          -  Known hypersensitivity to caffeine&#xD;
&#xD;
          -  Known history of liver and kidney insufficiencies&#xD;
&#xD;
          -  Known contraindications to Red Bull™ use&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Neil Fleshner, MD, FRCSC, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Health Network, Toronto</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Health Network</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T 1C1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>December 2013</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <last_update_submitted>December 18, 2013</last_update_submitted>
  <last_update_submitted_qc>December 18, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 19, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatigue</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/NCT01669460
org study id: 12-5041-C
nct id: NCT01669460
lead sponsor: 
has dmc: Yes
The purpose of this research study is to find out if Red Bull™ Sugar-Free Drink can reduce
      fatigue in prostate cancer patients receiving LHRH agonist therapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Reduction in overall fatigue as measured by Bruera global fatigue severity scale.
time frame: Within 4 days after completion of intervention (28 days of Red Bull™)
measure: Overall improvement in quality of life as measured by the Medical Outcomes Study Short-Form (SF-36)
time frame: Within 4 days after completion of intervention (28 days of Red Bull™)
arm group label: Red Bull™ Sugar-Free Drink
arm group type: Experimental
description: Red Bull™ Sugar-Free Drink: two (250mL) cans per day for 28 days
intervention type: Other
intervention name: Red Bull™ Sugar-Free Drink
description: Red Bull™ Sugar-Free Drink two (250mL) cans per day for 28 days
arm group label: Red Bull™ Sugar-Free Drink
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Neil Fleshner, MD, FRCSC, MPH
role: Principal Investigator
affiliation: University Health Network, Toronto
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Fatigue