xml: <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/NCT05988060</url>
    </required_header>
    <id_info>
      <org_study_id>NL79549.028.21</org_study_id>
      <nct_id>NCT05988060</nct_id>
    </id_info>
    <brief_title>Physical Exercise for Patients With Head and Neck Cancer</brief_title>
    <acronym>VITAL</acronym>
    <official_title>The Effect of Physical Exercise During Radiotherapy on Physical Functioning in Patients With Head and Neck Cancer: a Trial Within Cohorts, the VITAL Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Institute Verbeeten</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Verbeeten Fonds</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Stichting Fight Cancer</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>CZ Fonds</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Institute Verbeeten</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 goal of this trial within cohorts study is to determine and compare physical performance,&#xD;
        muscle strength, fatigue, quality of life, body composition, nutritional status, physical&#xD;
        activity, treatment tolerability of radiotherapy (RT), chemoradiation (CRT) or bioradiation&#xD;
        (BRT), and healthcare related costs in patients with head and neck cancer (HNC) with and&#xD;
        without a 10 week physical exercise intervention (PEI) during RT, CRT or BRT ((C/B)RT).&#xD;
  &#xD;
        Patients who were randomized in the PEI group and accepted the invitation to undergo the&#xD;
        experimental intervention receive a PEI twice a week for 10 weeks. The PEI will be executed 6&#xD;
        to 7 weeks during and 3 to 4 weeks after (C/B)RT.&#xD;
  &#xD;
        Researchers will compare patients who undergo the PEI with patients who did not undergo the&#xD;
        PEI to see if there is difference in physical performance, muscle strength, fatigue, Quality&#xD;
        of Life, body composition, nutritional status, physical activity, treatment tolerability of&#xD;
        (C/B)RT , and healthcare related costs in patients with Head and Neck Cancer (HNC) with and&#xD;
        without a 10 week Physical Exercise Intervention (PEI) during (C/B)RT).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">November 9, 2022</start_date>
    <completion_date type="Anticipated">November 9, 2026</completion_date>
    <primary_completion_date type="Anticipated">November 9, 2025</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>
      <intervention_model_description>In this study a TwiCs design will be used. The TwiCs design consists of an experimental intervention study within an observational longitudinal cohort. This design uses a staged-informed consent. Patients will be asked to participate in an observational longitudinal cohort study and will be informed about the design with the probability to be randomly invited for an experimental intervention which they can accept or refuse. When patients are willing to participate in the observational longitudinal cohort, an informed consent (IC) will be signed. Directly after cohort enrollment, all patients will be randomized.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>physical performance</measure>
      <time_frame>M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)</time_frame>
      <description>six minute walking test</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Muscle strength</measure>
      <time_frame>M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)</time_frame>
      <description>Grip strength</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Muscle strength</measure>
      <time_frame>M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)</time_frame>
      <description>30 seconds chair to stand test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Muscle strength</measure>
      <time_frame>M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)</time_frame>
      <description>Microfet handheld dynamometer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health Related Quality of Life</measure>
      <time_frame>M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)</time_frame>
      <description>Assessed by the EuroQol- five dimensions- five level (EQ-5D-5L). This questionnaire contains 6 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression and a total score for global health. The first 5 item have 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The score of these item can range from 0 to 4. The higher the total score of these five items, the lower the quality of live. The global health scores on a range 0-100. The higher the score of this item, the higher the global health.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health Related Quality of Life</measure>
      <time_frame>M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)</time_frame>
      <description>Assessed by the European organisation for research and treatment for cancer quality of life questionnaire (EORTC QLQ-C30). This questionnaire contains 30 questions scoring 9 subscales and 6 single items: 5 functional scales, 3 symptom scales and 1 global health / quality of life scale. The score of each subscale of single items ranges from 0 to 100. A higher score on the functional scales means a high level of functioning. A higher score on the symptom scales means a high level of experiencing symptoms. A higher score on global health / quality of life means a high score of quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health Related Quality of Life</measure>
      <time_frame>M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)</time_frame>
      <description>Assessed by the European organisation for research and treatment for cancer quality of life questionnaire head and neck module (EORTC-QLQ-H&amp;N43). This questionnaire contains 43 specific head and neck cancer questions scoring 19 subscales of symptoms. The higher the score of the subscale, the higher the level symptomology.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fatigue</measure>
      <time_frame>M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)</time_frame>
      <description>Assessed by the multidimensional fatigue inventory (MFI). The MFI contains 20 items scoring the following domains: general, physical and mental fatigue, and reduced activity and motivation. Every scale scores 4 till 20. The greater the score, the more fatigue or limitations in live because of fatigue.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body composition</measure>
      <time_frame>M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)</time_frame>
      <description>body mass index (BMI)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Nutrition status</measure>
      <time_frame>M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)</time_frame>
      <description>Assessed by the short nutritional assessment questionnaire (SNAQ). The short nutritional assessment questionnaire (SNAQ) consists of three questions and will be used to monitor nutritional status and assess the risk of malnutrition. The total score of this questionnaire ranges from 0 to 7. 0 means no nutritional problems and a high score means malnutrition.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical activity</measure>
      <time_frame>M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)</time_frame>
      <description>Assessed by the short questionnaire to assess health enhancing physical activity (SQUASH). The SQUASH measures the frequency, duration and intensity of 4 different physical activity: physical activity going to work, physical activity during household activity, physical activity at work, physical activity in spare time. The higher the score, the higher the level of physical activity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tolerability of radiotherapy, chemoradiation or bioradiation</measure>
      <time_frame>M1 (12 weeks), M2 (6 months), M3 (12 months)</time_frame>
      <description>tolerability will be retrieved from medical records and registered as the percentage of scheduled treatment completion, percentage of (C/B)RT adjustment and type of (C/B)RT adjustment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>socio-demographic data and medical data</measure>
      <time_frame>M0 (baseline/before (C/B)RT)</time_frame>
      <description>age, gender, education, employment, marital status tumour site, disease stage, comorbidity, HPV status, tobacco and alcohol use, nutrition status and type of treatment.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">112</enrollment>
    <condition>Head and Neck Cancer</condition>
    <arm_group>
      <arm_group_label>Patients who were randomized in the PEI group and accepted the invitation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The experimental intervention consist of a PEI for 10 weeks. The PEI will be executed 6 to 7 weeks during and 3 to 4 weeks after (C/B)RT.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Patients who were not randomized in the PEI group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Patients will receive usual care.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Experimental Intervention</intervention_name>
      <description>Patients who were randomized in the PEI group and accepted the invitation to undergo the experimental intervention receive a PEI for 10 weeks. The PEI will be executed 6 to 7 weeks during and 3 to 4 weeks after (C/B)RT. The PEI consists of a 60 minutes intervention twice a week and will be supervised by a physiotherapist specialized in oncology.&#xD;
  Patients who receive the intervention also have to do home-based aerobic and muscle strength exercises by themselves three times a week.</description>
      <arm_group_label>Patients who were randomized in the PEI group and accepted the invitation</arm_group_label>
      <other_name>Physical Exercise Intervention</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. patients with HNC who are scheduled for (C/B)RT,&#xD;
  &#xD;
            2. ≥18 years of age,&#xD;
  &#xD;
            3. sufficient Dutch writing and reading skills,&#xD;
  &#xD;
            4. a Karnofsky performance status (KPS) &gt;60,&#xD;
  &#xD;
            5. able to walk ≥60m without a mobility aid, and&#xD;
  &#xD;
            6. no contraindication for physical activity as measured with the physical activity&#xD;
               readiness questionnaire (PAR-Q).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. recurrence of HNC and/or&#xD;
  &#xD;
            2. secondary HNC.&#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>Yvette Kriellaars, Msc.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Instituut Verbeeten</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Caroline Speksnijder, Dr.</last_name>
      <phone>+3188758040</phone>
      <email>C.M.Speksnijder@umcutrecht.nl</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jorine Vermaire, Dr.</last_name>
      <phone>+135947777</phone>
      <email>vermaire.j@bvi.nl</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Instituut Verbeeten</name>
        <address>
          <city>Tilburg</city>
          <state>Noord Brabant</state>
          <zip>5042 SB</zip>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>head and neck cancer</keyword>
    <keyword>chemo- or bioradiotherapy</keyword>
    <keyword>physical exercise intervention</keyword>
    <keyword>physical performance</keyword>
    <keyword>trial within cohorts</keyword>
    <keyword>TwiCs</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Head and Neck Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05988060
  org study id: NL79549.028.21
  nct id: NCT05988060
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this trial within cohorts study is to determine and compare physical performance,
        muscle strength, fatigue, quality of life, body composition, nutritional status, physical
        activity, treatment tolerability of radiotherapy (RT), chemoradiation (CRT) or bioradiation
        (BRT), and healthcare related costs in patients with head and neck cancer (HNC) with and
        without a 10 week physical exercise intervention (PEI) during RT, CRT or BRT ((C/B)RT).
  
        Patients who were randomized in the PEI group and accepted the invitation to undergo the
        experimental intervention receive a PEI twice a week for 10 weeks. The PEI will be executed 6
        to 7 weeks during and 3 to 4 weeks after (C/B)RT.
  
        Researchers will compare patients who undergo the PEI with patients who did not undergo the
        PEI to see if there is difference in physical performance, muscle strength, fatigue, Quality
        of Life, body composition, nutritional status, physical activity, treatment tolerability of
        (C/B)RT , and healthcare related costs in patients with Head and Neck Cancer (HNC) with and
        without a 10 week Physical Exercise Intervention (PEI) during (C/B)RT).
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: In this study a TwiCs design will be used. The TwiCs design consists of an experimental intervention study within an observational longitudinal cohort. This design uses a staged-informed consent. Patients will be asked to participate in an observational longitudinal cohort study and will be informed about the design with the probability to be randomly invited for an experimental intervention which they can accept or refuse. When patients are willing to participate in the observational longitudinal cohort, an informed consent (IC) will be signed. Directly after cohort enrollment, all patients will be randomized.
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: physical performance
  time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
  description: six minute walking test
  measure: Muscle strength
  time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
  description: Grip strength
  measure: Muscle strength
  time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
  description: 30 seconds chair to stand test
  measure: Muscle strength
  time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
  description: Microfet handheld dynamometer
  measure: Health Related Quality of Life
  time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
  description: Assessed by the EuroQol- five dimensions- five level (EQ-5D-5L). This questionnaire contains 6 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression and a total score for global health. The first 5 item have 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The score of these item can range from 0 to 4. The higher the total score of these five items, the lower the quality of live. The global health scores on a range 0-100. The higher the score of this item, the higher the global health.
  measure: Health Related Quality of Life
  time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
  description: Assessed by the European organisation for research and treatment for cancer quality of life questionnaire (EORTC QLQ-C30). This questionnaire contains 30 questions scoring 9 subscales and 6 single items: 5 functional scales, 3 symptom scales and 1 global health / quality of life scale. The score of each subscale of single items ranges from 0 to 100. A higher score on the functional scales means a high level of functioning. A higher score on the symptom scales means a high level of experiencing symptoms. A higher score on global health / quality of life means a high score of quality of life.
  measure: Health Related Quality of Life
  time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
  description: Assessed by the European organisation for research and treatment for cancer quality of life questionnaire head and neck module (EORTC-QLQ-H&N43). This questionnaire contains 43 specific head and neck cancer questions scoring 19 subscales of symptoms. The higher the score of the subscale, the higher the level symptomology.
  measure: Fatigue
  time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
  description: Assessed by the multidimensional fatigue inventory (MFI). The MFI contains 20 items scoring the following domains: general, physical and mental fatigue, and reduced activity and motivation. Every scale scores 4 till 20. The greater the score, the more fatigue or limitations in live because of fatigue.
  measure: Body composition
  time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
  description: body mass index (BMI)
  measure: Nutrition status
  time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
  description: Assessed by the short nutritional assessment questionnaire (SNAQ). The short nutritional assessment questionnaire (SNAQ) consists of three questions and will be used to monitor nutritional status and assess the risk of malnutrition. The total score of this questionnaire ranges from 0 to 7. 0 means no nutritional problems and a high score means malnutrition.
  measure: Physical activity
  time frame: M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)
  description: Assessed by the short questionnaire to assess health enhancing physical activity (SQUASH). The SQUASH measures the frequency, duration and intensity of 4 different physical activity: physical activity going to work, physical activity during household activity, physical activity at work, physical activity in spare time. The higher the score, the higher the level of physical activity.
  measure: Tolerability of radiotherapy, chemoradiation or bioradiation
  time frame: M1 (12 weeks), M2 (6 months), M3 (12 months)
  description: tolerability will be retrieved from medical records and registered as the percentage of scheduled treatment completion, percentage of (C/B)RT adjustment and type of (C/B)RT adjustment.
  measure: socio-demographic data and medical data
  time frame: M0 (baseline/before (C/B)RT)
  description: age, gender, education, employment, marital status tumour site, disease stage, comorbidity, HPV status, tobacco and alcohol use, nutrition status and type of treatment.
  arm group label: Patients who were randomized in the PEI group and accepted the invitation
  arm group type: Experimental
  description: The experimental intervention consist of a PEI for 10 weeks. The PEI will be executed 6 to 7 weeks during and 3 to 4 weeks after (C/B)RT.
  arm group label: Patients who were not randomized in the PEI group
  arm group type: No Intervention
  description: Patients will receive usual care.
  intervention type: Other
  intervention name: Experimental Intervention
  description: Patients who were randomized in the PEI group and accepted the invitation to undergo the experimental intervention receive a PEI for 10 weeks. The PEI will be executed 6 to 7 weeks during and 3 to 4 weeks after (C/B)RT. The PEI consists of a 60 minutes intervention twice a week and will be supervised by a physiotherapist specialized in oncology.
  Patients who receive the intervention also have to do home-based aerobic and muscle strength exercises by themselves three times a week.
  arm group label: Patients who were randomized in the PEI group and accepted the invitation
  other name: Physical Exercise Intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Yvette Kriellaars, Msc.
  role: Principal Investigator
  affiliation: Instituut Verbeeten
  last name: Caroline Speksnijder, Dr.
  phone: +3188758040
  email: C.M.Speksnijder@umcutrecht.nl
  last name: Jorine Vermaire, Dr.
  phone: +135947777
  email: vermaire.j@bvi.nl
  facility: 
  status: Recruiting
  country: Netherlands
  responsible party type: Sponsor
  mesh term: Head and Neck Neoplasms
  sharing ipd: No