<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/NCT01688323</url>
  </required_header>
  <id_info>
    <org_study_id>LCCC1208</org_study_id>
    <secondary_id>12-0805</secondary_id>
    <nct_id>NCT01688323</nct_id>
  </id_info>
  <brief_title>Finding Predictors of Side Effects to Chemoradiation Treatment in Elderly Patients With Head and Neck Cancer</brief_title>
  <official_title>Identification of Predictors of Tolerance to Chemoradiotherapy in Elderly Patients With Head and Neck Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UNC Lineberger Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>UNC Lineberger Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To look at what types of measures can be used to predict how an older person will tolerate&#xD;
      chemoradiation treatment for head and neck cancer. This study uses surveys and a blood draw&#xD;
      to look at the different measures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose: To identify baseline predictors of change in function over the course of treatment&#xD;
      with chemoradiotherapy in patients with head and neck cancer.&#xD;
&#xD;
      Participants: Patients 65 or older who have an appointment at the North Carolina Cancer&#xD;
      Hospital (NCCH) or other participating sites, have planned chemoradiotherapy for head and&#xD;
      neck cancer&#xD;
&#xD;
      Procedures (methods): Consenting subjects will complete a Geriatric Assessment, Functional&#xD;
      Assessment of Cancer Therapy - Head and Neck and give a blood sample for CBC and p16INK4a at&#xD;
      the start of their chemoradiotherapy, at week four, at the end and 90 days post therapy. They&#xD;
      will also complete a health behavior questionnaire at baseline.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2012</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Significant Change in Function from Baseline to Post-Treatment</measure>
    <time_frame>2 years</time_frame>
    <description>To determine if there is a significant change in the Instrumental Activities of Daily Living (IADL) subscore of the Geriatric Assessment (GA) from baseline to 90 days post-treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Explore Association between Baseline Measures and Decline in Living Status</measure>
    <time_frame>2 years</time_frame>
    <description>To explore the association of baseline measures with time to decline in living status. (For example, completely independent to requiring home help, or requiring home help to moving to a nursing home, etc.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Explore Association of Baseline Measures with Grade 3 or Higher Toxicity</measure>
    <time_frame>2 years</time_frame>
    <description>To explore the association of baseline measures with the occurrence of any grade 3 or higher toxicity as a consequence of chemoradiotherapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Explore Association of Baseline p16 with Baseline GA Measures</measure>
    <time_frame>2 years</time_frame>
    <description>To explore the association of baseline p16 expression with baseline subscores of the Geriatric Assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Explore Changes in p16 Expression, GA Subscales and FACT-HN Scores Over Time.</measure>
    <time_frame>2 years</time_frame>
    <description>To explore changes in p16 expression, GA subscales, and FACT-HN scores over the course of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Explore Association between Baseline Measures and Changes in IADL Subscore</measure>
    <time_frame>2 years</time_frame>
    <description>To explore the association of baseline measures with change in IADL subscore.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">3</enrollment>
  <condition>Head and Neck Cancer</condition>
  <arm_group>
    <arm_group_label>Elderly Chemorads</arm_group_label>
    <description>Elderly patients with Head and Neck Cancer who are Undergoing Chemotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Collect Blood and Survey Instruments</intervention_name>
    <description>Each subject will be administered the appropriate surveys and blood draws over the course of the study.</description>
    <arm_group_label>Elderly Chemorads</arm_group_label>
    <other_name>Geriatric Assessment</other_name>
    <other_name>FACT-HN</other_name>
    <other_name>p16 Expression</other_name>
    <other_name>Health Behavior Questionnaire</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole Blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Elderly (65 and older) patients with Head and Neck Cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Patients will be eligible for this protocol provided they have an appointment at the&#xD;
             North Carolina Cancer Hospital (NCCH), have planned chemoradiotherapy for head and&#xD;
             neck cancer (any histology) and consent to complete the Geriatric Assessment. No&#xD;
             exclusions will be made based on gender, ethnicity, performance status or race.&#xD;
             Patient must be able to read and speak English.&#xD;
&#xD;
          -  Signed, IRB approved written informed consent.&#xD;
&#xD;
          -  Age of at least 65 years.&#xD;
&#xD;
          -  Enrollment in other studies, both therapeutic and observational, will not result in&#xD;
             exclusion.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Inability to read and speak English.&#xD;
&#xD;
          -  Inability to comply with study for any other reason than language&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jared Weiss, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UNC Lineberger Comprehensive Cancer Center</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27514</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://unclineberger.org/patientcare/programs/geriatric</url>
    <description>UNC Geriatric Oncology Program</description>
  </link>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 14, 2012</study_first_submitted>
  <study_first_submitted_qc>September 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>September 11, 2017</last_update_submitted>
  <last_update_submitted_qc>September 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Geriatrics</keyword>
  <keyword>Oncology</keyword>
  <keyword>Biological Markers</keyword>
  <keyword>Survey Instruments</keyword>
  <keyword>p16</keyword>
  <keyword>Geriatric Oncology</keyword>
  <keyword>Biological Markers of Aging</keyword>
  <keyword>Symptom Assessment</keyword>
  <keyword>Cancer</keyword>
  <keyword>Older Persons</keyword>
  <keyword>Head and Neck Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</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/NCT01688323
org study id: LCCC1208
secondary id: 12-0805
nct id: NCT01688323
lead sponsor: 
has dmc: Yes
To look at what types of measures can be used to predict how an older person will tolerate
      chemoradiation treatment for head and neck cancer. This study uses surveys and a blood draw
      to look at the different measures.
Purpose: To identify baseline predictors of change in function over the course of treatment
      with chemoradiotherapy in patients with head and neck cancer.

      Participants: Patients 65 or older who have an appointment at the North Carolina Cancer
      Hospital (NCCH) or other participating sites, have planned chemoradiotherapy for head and
      neck cancer

      Procedures (methods): Consenting subjects will complete a Geriatric Assessment, Functional
      Assessment of Cancer Therapy - Head and Neck and give a blood sample for CBC and p16INK4a at
      the start of their chemoradiotherapy, at week four, at the end and 90 days post therapy. They
      will also complete a health behavior questionnaire at baseline.
observational model: Other
time perspective: Prospective
measure: Significant Change in Function from Baseline to Post-Treatment
time frame: 2 years
description: To determine if there is a significant change in the Instrumental Activities of Daily Living (IADL) subscore of the Geriatric Assessment (GA) from baseline to 90 days post-treatment.
measure: Explore Association between Baseline Measures and Decline in Living Status
time frame: 2 years
description: To explore the association of baseline measures with time to decline in living status. (For example, completely independent to requiring home help, or requiring home help to moving to a nursing home, etc.)
measure: Explore Association of Baseline Measures with Grade 3 or Higher Toxicity
time frame: 2 years
description: To explore the association of baseline measures with the occurrence of any grade 3 or higher toxicity as a consequence of chemoradiotherapy.
measure: Explore Association of Baseline p16 with Baseline GA Measures
time frame: 2 years
description: To explore the association of baseline p16 expression with baseline subscores of the Geriatric Assessment.
measure: Explore Changes in p16 Expression, GA Subscales and FACT-HN Scores Over Time.
time frame: 2 years
description: To explore changes in p16 expression, GA subscales, and FACT-HN scores over the course of treatment
measure: Explore Association between Baseline Measures and Changes in IADL Subscore
time frame: 2 years
description: To explore the association of baseline measures with change in IADL subscore.
arm group label: Elderly Chemorads
description: Elderly patients with Head and Neck Cancer who are Undergoing Chemotherapy
intervention type: Other
intervention name: Collect Blood and Survey Instruments
description: Each subject will be administered the appropriate surveys and blood draws over the course of the study.
arm group label: Elderly Chemorads
other name: Geriatric Assessment
other name: FACT-HN
other name: p16 Expression
other name: Health Behavior Questionnaire
Whole Blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Jared Weiss, MD
role: Principal Investigator
affiliation: University of North Carolina
facility: 
country: United States
url: https://unclineberger.org/patientcare/programs/geriatric
description: UNC Geriatric Oncology Program
responsible party type: Sponsor
mesh term: Head and Neck Neoplasms