<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/NCT01711892</url>
  </required_header>
  <id_info>
    <org_study_id>CIRE-04</org_study_id>
    <nct_id>NCT01711892</nct_id>
  </id_info>
  <brief_title>Health Effects of Soccer Training in Men With Prostate Cancer Receiving Androgen Deprivation Therapy</brief_title>
  <official_title>A Randomized Controlled Clinical Trial on the Effects of Recreational Soccer Training in Men With Prostate Cancer Receiving Androgen Deprivation Therapy: The FC Prostate Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Danish Cancer Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Novo Nordisk A/S</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>TrygFonden, Denmark</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beckett Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Copenhagen</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Androgen Deprivation Therapy (ADT) is standard treatment for locally advanced or advanced&#xD;
      Prostate Cancer (PC).&#xD;
&#xD;
      The musculoskeletal toxicity associated with ADT is well established, leading to a decrease&#xD;
      in muscle mass, increased fat percentage, weight gain, sexual dysfunction and increased risk&#xD;
      of depression, fatigue, diabetes, cardiovascular disease and reduced quality of life.&#xD;
&#xD;
      Numerous studies have shown an association between physical activity, physical capacity and&#xD;
      quality of life in cancer patients and recent epidemiological research suggest that regular,&#xD;
      moderate-intensity physical activity may have a positive effect on survival in men with&#xD;
      prostate cancer.&#xD;
&#xD;
      Within exercise physiology there is new evidence pointing to recreational soccer as a unique&#xD;
      form of intermittent exercise that effectively stimulates aerobic and anaerobic energy&#xD;
      delivery systems, leading to beneficial musculoskeletal, metabolic and cardiovascular&#xD;
      adaptations of importance for health.&#xD;
&#xD;
      It is our overall hypothesis that 12 weeks of recreational soccer training 2-3 times per week&#xD;
      will improve the health profile of PC patients receiving ADT treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Baseline to post intervention (12 weeks) and follow-up (32 weeks) change in Body Composition.</measure>
    <time_frame>Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)</time_frame>
    <description>Changes in body composition assessed by Dual-energy X-ray absorptiometry(DXA)scan</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bone Mineral Density</measure>
    <time_frame>Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiorespiratory fitness (Vo2 peak)</measure>
    <time_frame>Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)</time_frame>
    <description>Change in maximal oxygen consumption (Vo2 peak) assessed directly during an incremental test on a cycle ergometer from baseline to post-intervention (12 weeks) and follow-up (32 weeks).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported outcomes</measure>
    <time_frame>Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)</time_frame>
    <description>Changes in Psychological distress (Hospital Anxiety and Depression Scale, HADS), Quality of Life (EORTC QLQ C-30), general well-being (SF-36), disease specific symptoms and side-effects (EORTC PR-25)from baseline to post-intervention (12 weeks) and follow-up (32 weeks)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart function</measure>
    <time_frame>Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)</time_frame>
    <description>Changes in Heart function measured by Echocardiography from baseline to post-intervention (12 weeks) and follow-up (32 weeks)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose tolerance</measure>
    <time_frame>Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)</time_frame>
    <description>Oral Glucose Tolerance Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postural Balance</measure>
    <time_frame>Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)</time_frame>
    <description>Assessed standing on a force platform with feet in bilateral, unilateral and tandem position. Additionally assessed with a modified Flamingo balance test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical function</measure>
    <time_frame>Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)</time_frame>
    <description>Physical function will be assessed with sit to stand test (30s), stair climbing test and Counter Movement Jump (jump height)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hip to waist ratio</measure>
    <time_frame>Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)</time_frame>
    <description>Hip and waist circumference will be measured and the hip to waist ratio will be calculated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle Strength</measure>
    <time_frame>Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)</time_frame>
    <description>Muscle strength will be assessed with the 1Repetition Maximum test for knee extensors</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood markers</measure>
    <time_frame>Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)</time_frame>
    <description>Markers of inflammation and bone metabolism will be obtained after overnight fasting</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>Prostatic Neoplasms</condition>
  <condition>Exercise</condition>
  <condition>Soccer Training</condition>
  <condition>Androgen Deprivation Therapy</condition>
  <arm_group>
    <arm_group_label>Soccer Training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>12 weeks of soccer training. (2 times per week for the first 8 weeks and 3 times per week in the last 4 weeks. Training will consist of 15 minutes warm-up and 2 x 15 minutes matches for the first 4 weeks and of 15 minutes warm-up and 3 x 15 minutes matches for the last 8 weeks). After 12 weeks assessments participants in the intervention group will continue bi-weekly supervised training for additional 20 weeks at the end of which tests will be repeated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Soccer training</intervention_name>
    <arm_group_label>Soccer Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Patients with locally advanced or advanced prostate cancer being treated with androgen&#xD;
        deprivation therapy (S-testosterone &lt; 1.7) for at least 6 months at the time of inclusion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  WHO performance level above 1,symptomatic cardiovascular disorders, osteoporosis&#xD;
             (T-score below -2.5)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mikael Rørth, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Copenhagen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Copenhagen, Centre of Integrated Rehabilitation of Cancer Patients</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 2012</study_first_posted>
  <last_update_submitted>April 16, 2014</last_update_submitted>
  <last_update_submitted_qc>April 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 21, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Copenhagen</investigator_affiliation>
    <investigator_full_name>Jacob Uth</investigator_full_name>
    <investigator_title>Project manager, Ph.d student, Master of Health Science</investigator_title>
  </responsible_party>
  <keyword>Prostatic Neoplasms</keyword>
  <keyword>Prostate Cancer</keyword>
  <keyword>Exercise</keyword>
  <keyword>Soccer</keyword>
  <keyword>Androgen Deprivation Therapy</keyword>
  <keyword>Body Composition</keyword>
  <keyword>Cardiovascular fitness</keyword>
  <keyword>Bone Health</keyword>
  <keyword>Health Related Quality of Life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</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/NCT01711892
org study id: CIRE-04
nct id: NCT01711892
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Androgen Deprivation Therapy (ADT) is standard treatment for locally advanced or advanced
      Prostate Cancer (PC).

      The musculoskeletal toxicity associated with ADT is well established, leading to a decrease
      in muscle mass, increased fat percentage, weight gain, sexual dysfunction and increased risk
      of depression, fatigue, diabetes, cardiovascular disease and reduced quality of life.

      Numerous studies have shown an association between physical activity, physical capacity and
      quality of life in cancer patients and recent epidemiological research suggest that regular,
      moderate-intensity physical activity may have a positive effect on survival in men with
      prostate cancer.

      Within exercise physiology there is new evidence pointing to recreational soccer as a unique
      form of intermittent exercise that effectively stimulates aerobic and anaerobic energy
      delivery systems, leading to beneficial musculoskeletal, metabolic and cardiovascular
      adaptations of importance for health.

      It is our overall hypothesis that 12 weeks of recreational soccer training 2-3 times per week
      will improve the health profile of PC patients receiving ADT treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Baseline to post intervention (12 weeks) and follow-up (32 weeks) change in Body Composition.
time frame: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
description: Changes in body composition assessed by Dual-energy X-ray absorptiometry(DXA)scan
measure: Bone Mineral Density
time frame: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
measure: Cardiorespiratory fitness (Vo2 peak)
time frame: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
description: Change in maximal oxygen consumption (Vo2 peak) assessed directly during an incremental test on a cycle ergometer from baseline to post-intervention (12 weeks) and follow-up (32 weeks).
measure: Patient reported outcomes
time frame: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
description: Changes in Psychological distress (Hospital Anxiety and Depression Scale, HADS), Quality of Life (EORTC QLQ C-30), general well-being (SF-36), disease specific symptoms and side-effects (EORTC PR-25)from baseline to post-intervention (12 weeks) and follow-up (32 weeks)
measure: Heart function
time frame: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
description: Changes in Heart function measured by Echocardiography from baseline to post-intervention (12 weeks) and follow-up (32 weeks)
measure: Glucose tolerance
time frame: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
description: Oral Glucose Tolerance Test
measure: Postural Balance
time frame: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
description: Assessed standing on a force platform with feet in bilateral, unilateral and tandem position. Additionally assessed with a modified Flamingo balance test.
measure: Physical function
time frame: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
description: Physical function will be assessed with sit to stand test (30s), stair climbing test and Counter Movement Jump (jump height)
measure: Hip to waist ratio
time frame: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
description: Hip and waist circumference will be measured and the hip to waist ratio will be calculated
measure: Muscle Strength
time frame: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
description: Muscle strength will be assessed with the 1Repetition Maximum test for knee extensors
measure: Blood markers
time frame: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
description: Markers of inflammation and bone metabolism will be obtained after overnight fasting
arm group label: Soccer Training
arm group type: Active Comparator
description: 12 weeks of soccer training. (2 times per week for the first 8 weeks and 3 times per week in the last 4 weeks. Training will consist of 15 minutes warm-up and 2 x 15 minutes matches for the first 4 weeks and of 15 minutes warm-up and 3 x 15 minutes matches for the last 8 weeks). After 12 weeks assessments participants in the intervention group will continue bi-weekly supervised training for additional 20 weeks at the end of which tests will be repeated.
arm group label: Control group
arm group type: No Intervention
description: Usual care
intervention type: Behavioral
intervention name: Soccer training
arm group label: Soccer Training
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Mikael Rørth, Professor
role: Principal Investigator
affiliation: University of Copenhagen
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University of Copenhagen
investigator full name: Jacob Uth
investigator title: Project manager, Ph.d student, Master of Health Science
mesh term: Prostatic Neoplasms