<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/NCT03252821</url>
  </required_header>
  <id_info>
    <org_study_id>1</org_study_id>
    <nct_id>NCT03252821</nct_id>
  </id_info>
  <brief_title>Effects of High-intensity Training Compared to Resistance Training in Cancer Patients Undergoing Radiotherapy</brief_title>
  <official_title>Effects of High-intensity Training Compared to Resistance Training in Cancer Patients Undergoing Radiotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to assess the impact of a high-intensity aerobic training and&#xD;
      resistance training on fatigue in prostate, head and neck and rectum cancer patients&#xD;
      undergoing radiotherapy.&#xD;
&#xD;
      A three-arm randomized controlled trial will be conducted. Patients will be randomised into&#xD;
      either a high-intensity aerobic training group or a resistance training group or a control&#xD;
      group. Participants in the training groups will exercised for five to eight weeks. Exercise&#xD;
      sessions will be take place 3 days per week under the supervision of an experienced&#xD;
      therapist. Subjects will be assessed at baseline and post-intervention. The primary outcome&#xD;
      will be fatigue measured using the FACIT-fatigue questionnaire. The secondary outcomes will&#xD;
      be: functional capacity, quality of life, executive functions, sleep disturbances, somnolence&#xD;
      syndrome, insomnia, depression symptoms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 15, 2017</start_date>
  <completion_date type="Actual">September 20, 2019</completion_date>
  <primary_completion_date type="Actual">September 1, 2019</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in fatigue</measure>
    <time_frame>Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)</time_frame>
    <description>Fatigue is measured by FACIT-fatigue questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in functional capacity</measure>
    <time_frame>Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)</time_frame>
    <description>Functional capacity is measured by 6-minute walk test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life</measure>
    <time_frame>Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)</time_frame>
    <description>Quality of life is measured by Functional Assessment of Cancer Therapy-General</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in sleep disturbances</measure>
    <time_frame>Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)</time_frame>
    <description>Sleep disturbances are measured by Pittsburgh Sleep Quality Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in somnolence syndrome</measure>
    <time_frame>Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)</time_frame>
    <description>Somnolence syndrome is measured by Epworth Sleepiness Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in insomnia</measure>
    <time_frame>Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)</time_frame>
    <description>Insomnia is measured by Insomnia Severity Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in depression symptoms</measure>
    <time_frame>Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)</time_frame>
    <description>Depression symptoms are measured by Center for Epidemiologic Studies Depression Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in executive functions</measure>
    <time_frame>Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)</time_frame>
    <description>Executive functions is measured by the Trail Making Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in dyspnea</measure>
    <time_frame>Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)</time_frame>
    <description>Dyspnea is measured by Multidimensional Dyspnea Profile</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence</measure>
    <time_frame>Weekly through the intervention (during 8 weeks)</time_frame>
    <description>Percentage of completed sessions</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Prostate Cancer</condition>
  <condition>Head and Neck Cancer</condition>
  <condition>Rectum Cancer</condition>
  <arm_group>
    <arm_group_label>High-intensity aerobic training group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High intensity interval training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Resistance training group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Muscle strengthening</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>High-intensity interval training</intervention_name>
    <description>High-intensity interval training sessions will be conducted on cycle ergometers or treadmill with heart rate measured throughout each session.</description>
    <arm_group_label>High-intensity aerobic training group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Resistance training</intervention_name>
    <description>Resistance exercise will be performed on eight exercises targeting major muscle groups at 60% to 85% of their estimated one-repetition maximum (1RM).</description>
    <arm_group_label>Resistance training group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria :&#xD;
&#xD;
          -  a primary diagnosis of prostate cancer, head and neck cancer (oral cavity, pharynx,&#xD;
             larynx, nasal cavity/sinuses, or salivary gland) or rectum cancer;&#xD;
&#xD;
          -  age over 18 years;&#xD;
&#xD;
          -  no distant metastases and/or disease progression;&#xD;
&#xD;
          -  at least 25 scheduled radiation treatments (5 weeks);&#xD;
&#xD;
          -  ability to read, write, and speak French.&#xD;
&#xD;
        Exclusion criteria :&#xD;
&#xD;
          -  uncontrolled cardiac, hypertensive or pulmonary diseases,&#xD;
&#xD;
          -  uncontrolled insulin-dependent diabetes mellitus,&#xD;
&#xD;
          -  neuropsychiatric disorders or orthopaedic conditions that would impair exercise&#xD;
             participation&#xD;
&#xD;
          -  abnormal electrocardiogram.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cliniques universitaires Saint-Luc</name>
      <address>
        <city>Brussels</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>March 16, 2020</last_update_submitted>
  <last_update_submitted_qc>March 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</investigator_affiliation>
    <investigator_full_name>Caty Gilles</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03252821
org study id: 1
nct id: NCT03252821
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to assess the impact of a high-intensity aerobic training and
      resistance training on fatigue in prostate, head and neck and rectum cancer patients
      undergoing radiotherapy.

      A three-arm randomized controlled trial will be conducted. Patients will be randomised into
      either a high-intensity aerobic training group or a resistance training group or a control
      group. Participants in the training groups will exercised for five to eight weeks. Exercise
      sessions will be take place 3 days per week under the supervision of an experienced
      therapist. Subjects will be assessed at baseline and post-intervention. The primary outcome
      will be fatigue measured using the FACIT-fatigue questionnaire. The secondary outcomes will
      be: functional capacity, quality of life, executive functions, sleep disturbances, somnolence
      syndrome, insomnia, depression symptoms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in fatigue
time frame: Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
description: Fatigue is measured by FACIT-fatigue questionnaire
measure: Change in functional capacity
time frame: Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
description: Functional capacity is measured by 6-minute walk test
measure: Change in quality of life
time frame: Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
description: Quality of life is measured by Functional Assessment of Cancer Therapy-General
measure: Change in sleep disturbances
time frame: Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
description: Sleep disturbances are measured by Pittsburgh Sleep Quality Index
measure: Change in somnolence syndrome
time frame: Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
description: Somnolence syndrome is measured by Epworth Sleepiness Scale
measure: Change in insomnia
time frame: Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
description: Insomnia is measured by Insomnia Severity Index
measure: Change in depression symptoms
time frame: Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
description: Depression symptoms are measured by Center for Epidemiologic Studies Depression Scale
measure: Change in executive functions
time frame: Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
description: Executive functions is measured by the Trail Making Test
measure: Change in dyspnea
time frame: Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
description: Dyspnea is measured by Multidimensional Dyspnea Profile
measure: Adherence
time frame: Weekly through the intervention (during 8 weeks)
description: Percentage of completed sessions
arm group label: High-intensity aerobic training group
arm group type: Experimental
description: High intensity interval training
arm group label: Resistance training group
arm group type: Active Comparator
description: Muscle strengthening
arm group label: Control group
arm group type: No Intervention
description: Usual care
intervention type: Behavioral
intervention name: High-intensity interval training
description: High-intensity interval training sessions will be conducted on cycle ergometers or treadmill with heart rate measured throughout each session.
arm group label: High-intensity aerobic training group
intervention type: Behavioral
intervention name: Resistance training
description: Resistance exercise will be performed on eight exercises targeting major muscle groups at 60% to 85% of their estimated one-repetition maximum (1RM).
arm group label: Resistance training group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
investigator full name: Caty Gilles
investigator title: Principal Investigator
mesh term: Rectal Neoplasms
sharing ipd: Undecided