<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/NCT02255773</url>
  </required_header>
  <id_info>
    <org_study_id>2014-0511</org_study_id>
    <secondary_id>NCI-2015-00012</secondary_id>
    <nct_id>NCT02255773</nct_id>
  </id_info>
  <brief_title>Exploring the Neuro-Immune Basis of Cancer-Related Fatigue Using Behavioral Measures</brief_title>
  <official_title>Exploring the Neuro-Immune Basis of Cancer-Related Fatigue Using Behavioral Measures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>M.D. Anderson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this research study is to learn more about fatigue and how it affects your&#xD;
      behavior as well as your willingness to learn new behaviors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      If you agree to take part in this study, the following tests and procedures will be&#xD;
      performed:&#xD;
&#xD;
        -  Blood (about 3 teaspoons) will be drawn to test for markers of inflammation and to test&#xD;
           for genes related to brain signaling. Markers of inflammation are found in the blood and&#xD;
           may be related to your fatigue and other symptoms.&#xD;
&#xD;
        -  You will complete three tasks on a computer. Some of the tasks are easy and you are&#xD;
           already used to them, but other ones will require some learning. You will be given&#xD;
           written instructions on how to complete them. The tasks will be completed in or near the&#xD;
           Head and Neck Cancer outpatient clinics. It should take about 60 minutes to complete all&#xD;
           three tasks.&#xD;
&#xD;
        -  You will complete 9 questionnaires about your mood, fatigue, sleep quality, and other&#xD;
           symptoms. It should take about 30 minutes to complete these questionnaires.&#xD;
&#xD;
      The questionnaires will be given a code number and stored in a locked file cabinet at MD&#xD;
      Anderson. No identifying information will be directly linked to your questionnaires. Only the&#xD;
      researcher in charge of the study will have access to the code numbers and be able to link&#xD;
      the questionnaires to you.&#xD;
&#xD;
      Length of Study:&#xD;
&#xD;
      After you have completed the blood draw, the computerized tasks, and the questionnaires, your&#xD;
      participation on this study will be over.&#xD;
&#xD;
      Additional Information:&#xD;
&#xD;
      Any information about your symptoms that is collected as part of this study is for research&#xD;
      purposes only. The questionnaires will only be used for the purposes of this study and will&#xD;
      be destroyed after the study results have been reported.&#xD;
&#xD;
      If you describe a symptom as being severe on the symptom questionnaire, a study staff member&#xD;
      will ask you if you have already told or plan to tell your doctor or nurse about the symptom.&#xD;
      If you have not already told your doctor or nurse, a study staff member will tell your doctor&#xD;
      or nurse about the symptom for you.&#xD;
&#xD;
      This is an investigational study.&#xD;
&#xD;
      Up to 60 participants will be enrolled in this study. All will take part at MD Anderson.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 4, 2014</start_date>
  <completion_date type="Anticipated">January 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fatigue Comparison in Male Head and Neck Cancer Survivors</measure>
    <time_frame>1 day</time_frame>
    <description>Endpoint for Effort Expenditure for Rewards Task (EEfRT) is ratio of hard task choices (number of hard task choices/total choices) across levels of probability. Endpoints for associative learning task are number of trials until reaching the a priori defined learning criterion (three consecutive correct responses for each association), indicating goal-directed learning, and number of trials between reaching this criterion and reaching asymptote in the reaction times, indicating establishment of habitual behavior. Set-switching task primary endpoints is difference in reaction times and number of errors between &quot;no-switch&quot; and &quot;switch&quot; trials.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Markers of Inflammation and Fatigue</measure>
    <time_frame>1 day</time_frame>
    <description>Frequency of each COMT genotype (Val/Val; Met/Met; Val/Met) compared between high-fatigue and low-fatigue survivors.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Head and Neck Cancer</condition>
  <arm_group>
    <arm_group_label>High-Fatigue Head and Neck (HNC) Cancer Survivors</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants undergo assessment with three validated computerized tasks designed to measure the neurobehavioral domains of interest: the Effort Expenditure for Rewards Task (EEfRT), an associative learning task, and a set-switch task. Participants complete questionnaires assessing mood, somatic symptoms, and sleep quality, including the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF), the Checklist Individual Strength (CIS), and others. A 10-mL blood sample drawn for assessment of inflammatory markers and COMT and DAT1 genotype.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low-Fatigue Head and Neck (HNC) Cancer Survivors</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants undergo assessment with three validated computerized tasks designed to measure the neurobehavioral domains of interest: the Effort Expenditure for Rewards Task (EEfRT), an associative learning task, and a set-switch task. Participants complete questionnaires assessing mood, somatic symptoms, and sleep quality, including the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF), the Checklist Individual Strength (CIS), and others. A 10-mL blood sample drawn for assessment of inflammatory markers and COMT and DAT1 genotype.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Computerized Tasks</intervention_name>
    <description>3 computerized tasks completed to assess motivation, learning of goal-directed and habitual behavior, and flexibility in switching between behavior strategies. It should take about 60 minutes to complete all three tasks.</description>
    <arm_group_label>High-Fatigue Head and Neck (HNC) Cancer Survivors</arm_group_label>
    <arm_group_label>Low-Fatigue Head and Neck (HNC) Cancer Survivors</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>Completion of 8 questionnaires about mood, fatigue, sleep quality, and other symptoms. It should take about 30 minutes to complete these questionnaires.</description>
    <arm_group_label>High-Fatigue Head and Neck (HNC) Cancer Survivors</arm_group_label>
    <arm_group_label>Low-Fatigue Head and Neck (HNC) Cancer Survivors</arm_group_label>
    <other_name>Surveys</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male patients at least 18 years old.&#xD;
&#xD;
          2. Patients who completed either definitive or postoperative radiation or chemoradiation&#xD;
             therapy for head and neck cancer within the past 6 weeks to 120 months.&#xD;
&#xD;
          3. Patients who speak English.&#xD;
&#xD;
          4. Patients who are willing and able to review, understand, and provide written consent.&#xD;
&#xD;
          5. Patients who agree to comply with all study procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with clinical evidence of active persistent cancer or progressive disease&#xD;
             after completing planned cancer therapy, or with active recurrent cancer.&#xD;
&#xD;
          2. Patients with potential medical or other underlying causes of fatigue, as determined&#xD;
             by the treating physician or Principal Investigator.&#xD;
&#xD;
          3. Patients with underlying cardiac or pulmonary disease resulting in dyspnea, hypoxia,&#xD;
             or hypercapnia.&#xD;
&#xD;
          4. Patients with major depressive disorder or severe depression (a score of 22 or greater&#xD;
             on the Center for Epidemiologic Studies Depression (CES-D)); for scores of 16 or&#xD;
             higher, we will notify the patient's treating physician within 1 working day of the&#xD;
             screening to allow for appropriate management or referral.&#xD;
&#xD;
          5. Patients currently taking, or having taken within the previous 1 month, armodafinil,&#xD;
             modafinil, amphetamine, or methylphenidate.&#xD;
&#xD;
          6. Patients who are enrolled and receiving active treatment in a symptom intervention&#xD;
             trial or who are in the treatment phase of a clinical trial.&#xD;
&#xD;
          7. Patients experiencing moderate to severe pain (4 or higher on a 0 to 10 scale) at the&#xD;
             time of screening.&#xD;
&#xD;
          8. Patients who cannot distinguish between the red and blue stimuli of the set-switch&#xD;
             task.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Dantzer, DMV,PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>University of Texas MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <last_update_submitted>September 5, 2023</last_update_submitted>
  <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Head and Neck Cancer</keyword>
  <keyword>HNC</keyword>
  <keyword>Moderate to severe fatigue</keyword>
  <keyword>Computerized tasks</keyword>
  <keyword>Questionnaires</keyword>
  <keyword>Surveys</keyword>
  <keyword>Disease-free adult males</keyword>
  <keyword>Cancer survivors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</mesh_term>
    <mesh_term>Fatigue</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/NCT02255773
org study id: 2014-0511
secondary id: NCI-2015-00012
nct id: NCT02255773
lead sponsor: 
has dmc: No
The goal of this research study is to learn more about fatigue and how it affects your
      behavior as well as your willingness to learn new behaviors.
If you agree to take part in this study, the following tests and procedures will be
      performed:

        -  Blood (about 3 teaspoons) will be drawn to test for markers of inflammation and to test
           for genes related to brain signaling. Markers of inflammation are found in the blood and
           may be related to your fatigue and other symptoms.

        -  You will complete three tasks on a computer. Some of the tasks are easy and you are
           already used to them, but other ones will require some learning. You will be given
           written instructions on how to complete them. The tasks will be completed in or near the
           Head and Neck Cancer outpatient clinics. It should take about 60 minutes to complete all
           three tasks.

        -  You will complete 9 questionnaires about your mood, fatigue, sleep quality, and other
           symptoms. It should take about 30 minutes to complete these questionnaires.

      The questionnaires will be given a code number and stored in a locked file cabinet at MD
      Anderson. No identifying information will be directly linked to your questionnaires. Only the
      researcher in charge of the study will have access to the code numbers and be able to link
      the questionnaires to you.

      Length of Study:

      After you have completed the blood draw, the computerized tasks, and the questionnaires, your
      participation on this study will be over.

      Additional Information:

      Any information about your symptoms that is collected as part of this study is for research
      purposes only. The questionnaires will only be used for the purposes of this study and will
      be destroyed after the study results have been reported.

      If you describe a symptom as being severe on the symptom questionnaire, a study staff member
      will ask you if you have already told or plan to tell your doctor or nurse about the symptom.
      If you have not already told your doctor or nurse, a study staff member will tell your doctor
      or nurse about the symptom for you.

      This is an investigational study.

      Up to 60 participants will be enrolled in this study. All will take part at MD Anderson.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Fatigue Comparison in Male Head and Neck Cancer Survivors
time frame: 1 day
description: Endpoint for Effort Expenditure for Rewards Task (EEfRT) is ratio of hard task choices (number of hard task choices/total choices) across levels of probability. Endpoints for associative learning task are number of trials until reaching the a priori defined learning criterion (three consecutive correct responses for each association), indicating goal-directed learning, and number of trials between reaching this criterion and reaching asymptote in the reaction times, indicating establishment of habitual behavior. Set-switching task primary endpoints is difference in reaction times and number of errors between "no-switch" and "switch" trials.
measure: Markers of Inflammation and Fatigue
time frame: 1 day
description: Frequency of each COMT genotype (Val/Val; Met/Met; Val/Met) compared between high-fatigue and low-fatigue survivors.
arm group label: High-Fatigue Head and Neck (HNC) Cancer Survivors
arm group type: Other
description: Participants undergo assessment with three validated computerized tasks designed to measure the neurobehavioral domains of interest: the Effort Expenditure for Rewards Task (EEfRT), an associative learning task, and a set-switch task. Participants complete questionnaires assessing mood, somatic symptoms, and sleep quality, including the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF), the Checklist Individual Strength (CIS), and others. A 10-mL blood sample drawn for assessment of inflammatory markers and COMT and DAT1 genotype.
arm group label: Low-Fatigue Head and Neck (HNC) Cancer Survivors
arm group type: Other
description: Participants undergo assessment with three validated computerized tasks designed to measure the neurobehavioral domains of interest: the Effort Expenditure for Rewards Task (EEfRT), an associative learning task, and a set-switch task. Participants complete questionnaires assessing mood, somatic symptoms, and sleep quality, including the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF), the Checklist Individual Strength (CIS), and others. A 10-mL blood sample drawn for assessment of inflammatory markers and COMT and DAT1 genotype.
intervention type: Behavioral
intervention name: Computerized Tasks
description: 3 computerized tasks completed to assess motivation, learning of goal-directed and habitual behavior, and flexibility in switching between behavior strategies. It should take about 60 minutes to complete all three tasks.
arm group label: High-Fatigue Head and Neck (HNC) Cancer Survivors
arm group label: Low-Fatigue Head and Neck (HNC) Cancer Survivors
intervention type: Behavioral
intervention name: Questionnaires
description: Completion of 8 questionnaires about mood, fatigue, sleep quality, and other symptoms. It should take about 30 minutes to complete these questionnaires.
arm group label: High-Fatigue Head and Neck (HNC) Cancer Survivors
arm group label: Low-Fatigue Head and Neck (HNC) Cancer Survivors
other name: Surveys
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Robert Dantzer, DMV,PHD
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: University of Texas MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Head and Neck Neoplasms
mesh term: Fatigue