<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/NCT03017417</url>
  </required_header>
  <id_info>
    <org_study_id>STH19598</org_study_id>
    <nct_id>NCT03017417</nct_id>
  </id_info>
  <brief_title>A COMbined progRamme of Exercise and Dietary ADvice in mEn With Castrate Resistant Prostate Cancer</brief_title>
  <acronym>COMRADE</acronym>
  <official_title>A COMbined progRamme of Exercise and Dietary ADvice in mEn With Castrate Resistant Prostate Cancer - COMRADE Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheffield Teaching Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sheffield Hallam University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sheffield Teaching Hospitals NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed study will assess the feasibility of an exercise and dietary intervention in men&#xD;
      with castrate resistant prostate cancer with secondary outcomes assessing improvements in&#xD;
      physical functioning, fatigue, quality of life, and body composition.The study will have 2&#xD;
      arms, with one set of participants randomized to resistance exercise training intervention&#xD;
      plus dietary advice and the other arm will be standard of care plus exercise advice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Although there have been advances in recent years, therapeutic options remain limited for men&#xD;
      with castrate resistant prostate cancer (CRPC). There is an unmet clinical need for&#xD;
      interventions which can improve quality of life, functional capacity and cancer related&#xD;
      fatigue. Adjunctive exercise therapy could be a potentially effective treatment for these&#xD;
      men. A growing body of evidence has demonstrated numerous benefits in physiological and&#xD;
      psychosocial outcomes in men with advanced prostate cancer. Further, there is observational&#xD;
      evidence linking physical activity with reduced disease specific mortality after a diagnosis&#xD;
      of cancer. Observational data also indicates that preserving skeletal muscle mass can improve&#xD;
      responses to chemotherapy. The proposed study will assess the feasibility of an exercise and&#xD;
      dietary intervention in men with castrate resistant prostate cancer with secondary outcomes&#xD;
      assessing improvements in physical functioning, fatigue, quality of life, and body&#xD;
      composition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">February 8, 2017</start_date>
  <completion_date type="Anticipated">June 2020</completion_date>
  <primary_completion_date type="Anticipated">June 2020</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants recruited who complete the intervention</measure>
    <time_frame>16 Weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants who show improvement in the Physical function assessments</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of participants who show improvement from treatment as shown by a DEXA scan</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of participants who show an increase in Muscle hypertrophy following intervention assessment</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of participants who show increases in Muscle Strength following intervention assessment</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of participants who show a higher score on Quality of life assessments following intervention</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of participants who adhere to the Diet diaries</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Prostatic Neoplasms, Castration-Resistant</condition>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Exercise Intervention arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>exercise training intervention to include:&#xD;
DEXA scan will collect data on via a full body scan to determine post-cranial appendicular whole body LM, whole body fat free mass (FFM) and whole body FM.&#xD;
Muscle Strength assessment&#xD;
Physical function assessment&#xD;
Questionnaires and diet diaries</description>
  </arm_group>
  <arm_group>
    <arm_group_label>standard of care arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>standard treatment&#xD;
exercise advice&#xD;
Questionnaires</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise Intervention</intervention_name>
    <description>Various exercise tests</description>
    <arm_group_label>Exercise Intervention arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>standard of care</intervention_name>
    <description>standard treatment</description>
    <arm_group_label>standard of care arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men with Castrate resistant prostate cancer&#xD;
&#xD;
          -  Men with histologically confirmed PCa on long-term ADT with either&#xD;
&#xD;
               -  PSA&gt;2ng/ml above nadir or PSA level that has risen serially on at least two&#xD;
                  occasions (each at least 4 weeks apart) in the presence of castrate levels of&#xD;
                  testosterone or;&#xD;
&#xD;
               -  Evidence of symptomatic disease progression whilst undergoing first line androgen&#xD;
                  deprivation therapy (ADT) in the presence of castrate levels of testosterone or;&#xD;
&#xD;
               -  Radiographic disease progression whilst undergoing first line ADT in the presence&#xD;
                  of castrate levels of testosterone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Participation in other trials which might bias the evaluation of the primary&#xD;
             objectives of the present study.&#xD;
&#xD;
               -  Current participation in regular physical activity (defined as purposeful&#xD;
                  physical activity of a moderate intensity for 90 minutes per week for at least&#xD;
                  six months).&#xD;
&#xD;
               -  Unstable angina, uncontrolled hypertension, recent myocardial infarction,&#xD;
                  pacemakers.&#xD;
&#xD;
               -  Uncontrolled painful or unstable bony metastatic lesions.&#xD;
&#xD;
               -  Within two months of invasive surgical treatment (transurethral surgery allowed).&#xD;
&#xD;
               -  Any physical, neurological or psychiatric impairment or disease or other&#xD;
                  condition that would limit the ability to understand and complete the study&#xD;
                  assessments and complete the required questionnaires, recall and record of&#xD;
                  dietary information would be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sheffield Teaching Hospital NHS Foundation Trust</name>
      <address>
        <city>Sheffield</city>
        <state>South Yorkshire</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>August 3, 2018</last_update_submitted>
  <last_update_submitted_qc>August 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2018</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>Prostatic Neoplasms</mesh_term>
    <mesh_term>Prostatic Neoplasms, Castration-Resistant</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>no plan to share data</ipd_description>
  </patient_data>
  <!-- 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/NCT03017417
org study id: STH19598
nct id: NCT03017417
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The proposed study will assess the feasibility of an exercise and dietary intervention in men
      with castrate resistant prostate cancer with secondary outcomes assessing improvements in
      physical functioning, fatigue, quality of life, and body composition.The study will have 2
      arms, with one set of participants randomized to resistance exercise training intervention
      plus dietary advice and the other arm will be standard of care plus exercise advice.
Although there have been advances in recent years, therapeutic options remain limited for men
      with castrate resistant prostate cancer (CRPC). There is an unmet clinical need for
      interventions which can improve quality of life, functional capacity and cancer related
      fatigue. Adjunctive exercise therapy could be a potentially effective treatment for these
      men. A growing body of evidence has demonstrated numerous benefits in physiological and
      psychosocial outcomes in men with advanced prostate cancer. Further, there is observational
      evidence linking physical activity with reduced disease specific mortality after a diagnosis
      of cancer. Observational data also indicates that preserving skeletal muscle mass can improve
      responses to chemotherapy. The proposed study will assess the feasibility of an exercise and
      dietary intervention in men with castrate resistant prostate cancer with secondary outcomes
      assessing improvements in physical functioning, fatigue, quality of life, and body
      composition.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Number of participants recruited who complete the intervention
time frame: 16 Weeks
measure: Number of participants who show improvement in the Physical function assessments
time frame: 16 weeks
measure: number of participants who show improvement from treatment as shown by a DEXA scan
time frame: 16 weeks
measure: number of participants who show an increase in Muscle hypertrophy following intervention assessment
time frame: 16 weeks
measure: number of participants who show increases in Muscle Strength following intervention assessment
time frame: 16 weeks
measure: number of participants who show a higher score on Quality of life assessments following intervention
time frame: 16 weeks
measure: number of participants who adhere to the Diet diaries
time frame: 16 weeks
arm group label: Exercise Intervention arm
arm group type: Experimental
description: exercise training intervention to include:
DEXA scan will collect data on via a full body scan to determine post-cranial appendicular whole body LM, whole body fat free mass (FFM) and whole body FM.
Muscle Strength assessment
Physical function assessment
Questionnaires and diet diaries
arm group label: standard of care arm
arm group type: Active Comparator
description: standard treatment
exercise advice
Questionnaires
intervention type: Other
intervention name: Exercise Intervention
description: Various exercise tests
arm group label: Exercise Intervention arm
intervention type: Other
intervention name: standard of care
description: standard treatment
arm group label: standard of care arm
criteria: 
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Prostatic Neoplasms, Castration-Resistant
sharing ipd: No
ipd description: no plan to share data