<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/NCT02192216</url>
  </required_header>
  <id_info>
    <org_study_id>SKDM2014</org_study_id>
    <secondary_id>41408</secondary_id>
    <nct_id>NCT02192216</nct_id>
  </id_info>
  <brief_title>The Effect of Resistance Training and Aerobic Training on Body Composition During Chemotherapy</brief_title>
  <official_title>The Effect of Resistance Training and Aerobic Training on Body Composition During Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Department of Public Health, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aarhus University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Department of Public Health, Denmark</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chemotherapy can induce muscle loss in colorectal, breast and advanced renal cell carcinoma&#xD;
      patients. The Danish nation-wide training and rehabilitation offer 'Body &amp; Cancer' offers&#xD;
      intensive resistance and endurance training to all Danish cancer patients receiving&#xD;
      chemotherapy with the aim of reducing treatment-related fatigue and physical impairments, but&#xD;
      the potential of the training to preserve or improve muscle mass is uninvestigated.&#xD;
&#xD;
      Furthermore, the underlying biological mechanisms of treatment and/or exercise induced&#xD;
      changes in muscle mass in cancer patients remains uninvestigated.&#xD;
&#xD;
      Thus, the primary purpose of the present study is to investigate changes in body composition&#xD;
      during chemotherapy and after resistance and aerobic training combined with protein&#xD;
      supplementation during ongoing chemotherapy in cancer patients. Secondly, we aim to&#xD;
      investigate the underlying biological mechanisms of muscle mass regulation in biopsies&#xD;
      obtained before and after a control period as well as after 10 weeks of exercise, both during&#xD;
      chemotherapy.&#xD;
&#xD;
      We hypothesize that 10 weeks exercise will improve muscle mass and body composition in cancer&#xD;
      patients during chemotherapy as compared to a control period during chemotherapy alone.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Recruiting issues and limited personel ressources&#xD;
  </why_stopped>
  <start_date>February 2014</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <phase>N/A</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>Changes in body composition</measure>
    <time_frame>Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).</time_frame>
    <description>Changes in lean body mass and fat mass wil be assessed using Dual Energy X-Ray Absorptiometry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in underlying biological mechanisms associated with changes in muscle mass</measure>
    <time_frame>Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).</time_frame>
    <description>Analyzed from muscle biopsies from m. vastus lateralis and venous blood samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in dynamic muscle strength</measure>
    <time_frame>Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).</time_frame>
    <description>Changes in muscle strength will be assessed using 1 repetition maximum (kg) tests using conventional training equipment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in aerobic performance</measure>
    <time_frame>Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).</time_frame>
    <description>Changes in aerobic performance will be assessed using the Watt max bicycle ergometer test. Maximal oxygen consumption (L O2 pr min) will be estimated based on this test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in cancer related fatigue and quality of life</measure>
    <time_frame>Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).</time_frame>
    <description>Changes in cancer related fatigue and quality of life wil be assessed using the European Organisation for Research and Treatment of Cancer (EORTC) questionaire QLQ C30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in functional performance</measure>
    <time_frame>Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).</time_frame>
    <description>Changes in functional performance will be assessed using various validated functional performance tests. Thus, changes will be asssessed in 30 s arm curl test (max repetitions) , 30 s chair rise test (max repetitions), stair climbing test (time to ascend to flights of stairs), 10 m maximal gait speed test (time to walk 10 m as fast as possible).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">16</enrollment>
  <condition>Neoplasms</condition>
  <arm_group>
    <arm_group_label>Exercise &amp; Chemotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Following a control period during active chemotherapy the patients undergo ten weeks of supervised exercise comprised of resistance and aerobic training in combination with protein supplementation during ongoing chemotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <arm_group_label>Exercise &amp; Chemotherapy</arm_group_label>
    <other_name>Resistance training</other_name>
    <other_name>Aerobic exercise</other_name>
    <other_name>Protein supplementation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Currently receiving curative, adjuvant, neo-adjuvant or palliative chemotherapy&#xD;
&#xD;
          -  No documented bone metastases or myelomatosis&#xD;
&#xD;
          -  No documented CNS affection&#xD;
&#xD;
          -  WHO performance status 0-1&#xD;
&#xD;
          -  No chronical thrombocytopenia or leukopenia&#xD;
&#xD;
          -  No physical conditions preventing exercise participation&#xD;
&#xD;
          -  No serious symptoms of heart disease&#xD;
&#xD;
          -  No dementia or mental illness preventing participation&#xD;
&#xD;
          -  Signed written concent&#xD;
&#xD;
          -  Age above 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in systematic resistance training three months prior to inclusion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Simon Loenbro, M.Sc., PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dept. of Public Health, Sect. for Sports Science, Aarhus University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dept of Oncology, Aarhus University Hospital</name>
      <address>
        <city>Aarhus C</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>July 4, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>February 28, 2018</last_update_submitted>
  <last_update_submitted_qc>February 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Department of Public Health, Denmark</investigator_affiliation>
    <investigator_full_name>Simon Lønbro</investigator_full_name>
    <investigator_title>M.Sc., PhD.</investigator_title>
  </responsible_party>
  <keyword>Body composition</keyword>
  <keyword>Chemotherapy</keyword>
  <keyword>Muscle mass</keyword>
  <keyword>Muscle function</keyword>
  <keyword>Exercise</keyword>
  <!-- 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/NCT02192216
org study id: SKDM2014
secondary id: 41408
nct id: NCT02192216
lead sponsor: 
collaborator: 
has dmc: Yes
Chemotherapy can induce muscle loss in colorectal, breast and advanced renal cell carcinoma
      patients. The Danish nation-wide training and rehabilitation offer 'Body & Cancer' offers
      intensive resistance and endurance training to all Danish cancer patients receiving
      chemotherapy with the aim of reducing treatment-related fatigue and physical impairments, but
      the potential of the training to preserve or improve muscle mass is uninvestigated.

      Furthermore, the underlying biological mechanisms of treatment and/or exercise induced
      changes in muscle mass in cancer patients remains uninvestigated.

      Thus, the primary purpose of the present study is to investigate changes in body composition
      during chemotherapy and after resistance and aerobic training combined with protein
      supplementation during ongoing chemotherapy in cancer patients. Secondly, we aim to
      investigate the underlying biological mechanisms of muscle mass regulation in biopsies
      obtained before and after a control period as well as after 10 weeks of exercise, both during
      chemotherapy.

      We hypothesize that 10 weeks exercise will improve muscle mass and body composition in cancer
      patients during chemotherapy as compared to a control period during chemotherapy alone.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Changes in body composition
time frame: Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).
description: Changes in lean body mass and fat mass wil be assessed using Dual Energy X-Ray Absorptiometry
measure: Changes in underlying biological mechanisms associated with changes in muscle mass
time frame: Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).
description: Analyzed from muscle biopsies from m. vastus lateralis and venous blood samples
measure: Changes in dynamic muscle strength
time frame: Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).
description: Changes in muscle strength will be assessed using 1 repetition maximum (kg) tests using conventional training equipment.
measure: Changes in aerobic performance
time frame: Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).
description: Changes in aerobic performance will be assessed using the Watt max bicycle ergometer test. Maximal oxygen consumption (L O2 pr min) will be estimated based on this test.
measure: Changes in cancer related fatigue and quality of life
time frame: Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).
description: Changes in cancer related fatigue and quality of life wil be assessed using the European Organisation for Research and Treatment of Cancer (EORTC) questionaire QLQ C30
measure: Changes in functional performance
time frame: Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).
description: Changes in functional performance will be assessed using various validated functional performance tests. Thus, changes will be asssessed in 30 s arm curl test (max repetitions) , 30 s chair rise test (max repetitions), stair climbing test (time to ascend to flights of stairs), 10 m maximal gait speed test (time to walk 10 m as fast as possible).
arm group label: Exercise & Chemotherapy
arm group type: Experimental
description: Following a control period during active chemotherapy the patients undergo ten weeks of supervised exercise comprised of resistance and aerobic training in combination with protein supplementation during ongoing chemotherapy.
intervention type: Behavioral
intervention name: Exercise
arm group label: Exercise & Chemotherapy
other name: Resistance training
other name: Aerobic exercise
other name: Protein supplementation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Simon Loenbro, M.Sc., PhD
role: Principal Investigator
affiliation: Dept. of Public Health, Sect. for Sports Science, Aarhus University
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Department of Public Health, Denmark
investigator full name: Simon Lønbro
investigator title: M.Sc., PhD.