<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/NCT03013699</url>
  </required_header>
  <id_info>
    <org_study_id>X140813004</org_study_id>
    <nct_id>NCT03013699</nct_id>
  </id_info>
  <brief_title>Diet Intervention, Head and Neck Cancer, Feasibility</brief_title>
  <official_title>Improving Dietary Patterns in Head and Neck Cancer Survivors to Optimize Disease Outcomes and Supportive Care: A Pilot/Feasibility Intervention Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will examine the effects of a dietary intervention in post-treatment head and neck&#xD;
      cancer survivors on the ability to function physically, tiredness, and quality of life, as&#xD;
      well as on changing markers in the blood that are associated with better recurrence and&#xD;
      survival.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients excluded or not agreeing to participate</measure>
    <time_frame>Baseline</time_frame>
    <description>Feasibility measure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence to study protocol activities (research records and diet intake self-report)</measure>
    <time_frame>Throughout 12 week study period</time_frame>
    <description>Feasibility measure (e.g., percent of assessments completed, percent of counseling phone calls completed, servings of cruciferous vegetables eaten, etc.)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Attrition rates</measure>
    <time_frame>Throughout 12 week study period</time_frame>
    <description>Feasibility measure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse events with reporting according to institutional review board policy</measure>
    <time_frame>Throughout 12 week study period</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Questionnaire</measure>
    <time_frame>At conclusion of 12 week study period</time_frame>
    <description>Participant satisfaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Questionnaire</measure>
    <time_frame>At conclusion of 12 week study period</time_frame>
    <description>Intervention preferences</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>DNA methylation</measure>
    <time_frame>At beginning and end of 12 week study period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum cytokines</measure>
    <time_frame>At beginning and end of 12 week study period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (assessed using the Functional Assessment of Cancer Therapy Head and Neck index)</measure>
    <time_frame>At beginning and end of 12 week study period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total energy and nutrient intakes</measure>
    <time_frame>At beginning and end of 12 week study period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Covariates</measure>
    <time_frame>At beginning of 12 week study period</time_frame>
    <description>A questionnaire will collect a set of covariates used in the analyses (i.e., these do not represent individual outcomes; this is a group of covariates used in the data analyses). This group includes demographic characteristics (age, sex, race, ethnicity, education, income); lifestyle behaviors (tobacco use, alcohol consumption, exercise); medical history; cancer-specific clinical variables (tumor site, cancer stage, treatment modality); anthropometrics (height and weight)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Head and Neck Cancer</condition>
  <arm_group>
    <arm_group_label>Usual Dietary Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants receive standard educational materials that focus on healthy eating for cancer survivors and the opportunity to briefly discuss nutrition-related concerns with the Registered Dietitian weekly.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cruciferous and Dark Leafy Green Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive individual dietary counseling from a Registered Dietitian who will focus on increasing intake of cruciferous and green leafy vegetables while addressing any disease- and treatment-related eating difficulties experienced by the participant.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cruciferous and Dark Leafy Green Intervention</intervention_name>
    <description>Participants receive individual dietary counseling from a Registered Dietitian who will focus on increasing intake of cruciferous and green leafy vegetables while addressing any disease- and treatment-related eating difficulties experienced by the participant.</description>
    <arm_group_label>Cruciferous and Dark Leafy Green Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual Dietary Care</intervention_name>
    <description>Participants receive standard educational materials that focus on healthy eating for cancer survivors and the opportunity to briefly discuss nutrition-related concerns with the Registered Dietitian weekly.</description>
    <arm_group_label>Usual Dietary Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients will be eligible to participate if they are 1) diagnosed with Stage I - IV oral,&#xD;
        hypopharyngeal, nasopharyngeal, oropharyngeal, or laryngeal cancer; 2) age 19+; 3) at least&#xD;
        6 months - 2 years post-treatment; 4) able to consume foods orally; 5) no evidence of&#xD;
        disease; 6) English-speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients will not be eligible to participate if they have 1) dementia or organic brain&#xD;
        syndrome; 2) severe emotional distress; 3) active schizophrenia; 3) another diagnosis of&#xD;
        cancer in the past five years (not including skin or cervical cancer in situ)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laura Q. Rogers, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>January 4, 2017</last_update_submitted>
  <last_update_submitted_qc>January 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Laura Q. Rogers, MD, MPH</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>diet</keyword>
  <keyword>nutrition</keyword>
  <keyword>survival</keyword>
  <keyword>recurrence</keyword>
  <keyword>cruciferous</keyword>
  <keyword>dark leafy greens</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>


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/NCT03013699
org study id: X140813004
nct id: NCT03013699
lead sponsor: 
has dmc: No
This study will examine the effects of a dietary intervention in post-treatment head and neck
      cancer survivors on the ability to function physically, tiredness, and quality of life, as
      well as on changing markers in the blood that are associated with better recurrence and
      survival.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of patients excluded or not agreeing to participate
time frame: Baseline
description: Feasibility measure
measure: Adherence to study protocol activities (research records and diet intake self-report)
time frame: Throughout 12 week study period
description: Feasibility measure (e.g., percent of assessments completed, percent of counseling phone calls completed, servings of cruciferous vegetables eaten, etc.)
measure: Attrition rates
time frame: Throughout 12 week study period
description: Feasibility measure
measure: Adverse events with reporting according to institutional review board policy
time frame: Throughout 12 week study period
measure: Questionnaire
time frame: At conclusion of 12 week study period
description: Participant satisfaction
measure: Questionnaire
time frame: At conclusion of 12 week study period
description: Intervention preferences
measure: DNA methylation
time frame: At beginning and end of 12 week study period
measure: Serum cytokines
time frame: At beginning and end of 12 week study period
measure: Quality of life (assessed using the Functional Assessment of Cancer Therapy Head and Neck index)
time frame: At beginning and end of 12 week study period
measure: Total energy and nutrient intakes
time frame: At beginning and end of 12 week study period
measure: Covariates
time frame: At beginning of 12 week study period
description: A questionnaire will collect a set of covariates used in the analyses (i.e., these do not represent individual outcomes; this is a group of covariates used in the data analyses). This group includes demographic characteristics (age, sex, race, ethnicity, education, income); lifestyle behaviors (tobacco use, alcohol consumption, exercise); medical history; cancer-specific clinical variables (tumor site, cancer stage, treatment modality); anthropometrics (height and weight)
arm group label: Usual Dietary Care
arm group type: Active Comparator
description: Participants receive standard educational materials that focus on healthy eating for cancer survivors and the opportunity to briefly discuss nutrition-related concerns with the Registered Dietitian weekly.
arm group label: Cruciferous and Dark Leafy Green Intervention
arm group type: Experimental
description: Participants receive individual dietary counseling from a Registered Dietitian who will focus on increasing intake of cruciferous and green leafy vegetables while addressing any disease- and treatment-related eating difficulties experienced by the participant.
intervention type: Behavioral
intervention name: Cruciferous and Dark Leafy Green Intervention
description: Participants receive individual dietary counseling from a Registered Dietitian who will focus on increasing intake of cruciferous and green leafy vegetables while addressing any disease- and treatment-related eating difficulties experienced by the participant.
arm group label: Cruciferous and Dark Leafy Green Intervention
intervention type: Behavioral
intervention name: Usual Dietary Care
description: Participants receive standard educational materials that focus on healthy eating for cancer survivors and the opportunity to briefly discuss nutrition-related concerns with the Registered Dietitian weekly.
arm group label: Usual Dietary Care
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Laura Q. Rogers, MD
role: Principal Investigator
affiliation: University of Alabama at Birmingham
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Laura Q. Rogers, MD, MPH
investigator title: Principal Investigator
mesh term: Head and Neck Neoplasms
sharing ipd: No