<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/NCT01676480</url>
  </required_header>
  <id_info>
    <org_study_id>H-4-2009-102</org_study_id>
    <nct_id>NCT01676480</nct_id>
  </id_info>
  <brief_title>The Effect of Endurance Training on Body Composition and Insulin Sensitivity in Prostate Cancer Patients Receiving Androgen Deprivation Therapy</brief_title>
  <official_title>The Effect of Endurance Training on Body Composition and Insulin Sensitivity in Prostate Cancer Patients Receiving ADT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inge Holm</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Herlev Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the present study is to investigate if endurance training can be used as a&#xD;
      therapeutic action against the adverse metabolic disturbances and unfavourable changes in&#xD;
      body composition that accompany the androgen deprivation therapy (ADT) treatment in prostate&#xD;
      cancer patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2009</start_date>
  <completion_date type="Actual">September 2011</completion_date>
  <primary_completion_date type="Actual">September 2011</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in body composition and insulin sensitivity in response to training</measure>
    <time_frame>Body composition and insulin sensitivity are measured at baseline and after 12 weeks of endurance training</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>ADT group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Endurance training</intervention_name>
    <description>12 weeks of endurance training 3 times per week</description>
    <arm_group_label>ADT group</arm_group_label>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Prostate cancer patients receiving ADT for at least 3 months&#xD;
&#xD;
          -  Healthy age and BMI matched controls&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe cardiovascular disease&#xD;
&#xD;
          -  severe arthritis&#xD;
&#xD;
          -  severe neuropathy&#xD;
&#xD;
          -  severe hypertension&#xD;
&#xD;
          -  therapy with antidiabetic agents&#xD;
&#xD;
          -  VO2max &gt; 30.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bente K Pedersen</last_name>
    <role>Study Director</role>
    <affiliation>Centre of Inflammation and Metabolism, Rigshospitalet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre of Inflammation and Metabolism, Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>January 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <last_update_submitted>September 3, 2012</last_update_submitted>
  <last_update_submitted_qc>September 3, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 5, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Inge Holm</investigator_full_name>
    <investigator_title>Administrator</investigator_title>
  </responsible_party>
  <keyword>Prostate cancer</keyword>
  <keyword>ADT</keyword>
  <keyword>Endurance training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
    <mesh_term>Insulin Resistance</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/NCT01676480
org study id: H-4-2009-102
nct id: NCT01676480
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of the present study is to investigate if endurance training can be used as a
      therapeutic action against the adverse metabolic disturbances and unfavourable changes in
      body composition that accompany the androgen deprivation therapy (ADT) treatment in prostate
      cancer patients.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in body composition and insulin sensitivity in response to training
time frame: Body composition and insulin sensitivity are measured at baseline and after 12 weeks of endurance training
arm group label: ADT group
arm group type: Experimental
arm group label: Control group
arm group type: Experimental
intervention type: Behavioral
intervention name: Endurance training
description: 12 weeks of endurance training 3 times per week
arm group label: ADT group
arm group label: Control group
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Bente K Pedersen
role: Study Director
affiliation: Centre of Inflammation and Metabolism, Rigshospitalet
facility: 
country: Denmark
responsible party type: Sponsor-Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Inge Holm
investigator title: Administrator
mesh term: Prostatic Neoplasms
mesh term: Insulin Resistance