<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/NCT02987881</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00074542</org_study_id>
    <nct_id>NCT02987881</nct_id>
  </id_info>
  <brief_title>Endometrial Cancer Diet and Exercise</brief_title>
  <official_title>Physical Activity and Nutrition Counseling Intervention in Endometrial Cancer Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Duke Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</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>
      This study will evaluate whether the use of the Jawbone wristband monitor, in connection with&#xD;
      home-based exercise and nutritional counseling can be safely completed and improve&#xD;
      cardiorespiratory fitness (heart and lung health) in women with early stage endometrial&#xD;
      cancer who have undergone surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">June 1, 2019</completion_date>
  <primary_completion_date type="Actual">June 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>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Open Label</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility as measured by adherence to weekly walking sessions</measure>
    <time_frame>Week 12</time_frame>
    <description>Percentage of daily steps divided by total number of steps and daily walking sessions divided by total number of sessions prescribed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety as measured by the type and prevalence of adverse events during study-related assessments</measure>
    <time_frame>Week 12</time_frame>
    <description>Collection of events related to cardiopulmonary testing and self-reported events during off-site exercise training</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in cardiorespiratory fitness and CVD risk profile as measured by VO2peak</measure>
    <time_frame>baseline and 12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>change in cardiorespiratory fitness and CVD risk profile as measured by blood pressure</measure>
    <time_frame>baseline and 12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>change in cardiorespiratory fitness and CVD risk profile as measured by lipid profile</measure>
    <time_frame>baseline and 12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>change in cardiorespiratory fitness and CVD risk profile as measured by C-reactive protein</measure>
    <time_frame>baseline and 12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>change in cardiorespiratory fitness and CVD risk profile as measured by body composition</measure>
    <time_frame>baseline and 12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>patient experience with exercise and nutrition counseling as measured by telephone questionnaire</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Early Stage Endometrial Cancer</condition>
  <arm_group>
    <arm_group_label>Adult women with early stage localized endometrial cancer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adult women with early stage localized endometrial cancer at least 2 months following hysterectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Home-based aerobic exercise and nutritional counseling</intervention_name>
    <description>Moderate walking and running with nutritional counseling at study visits.</description>
    <arm_group_label>Adult women with early stage localized endometrial cancer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages &gt; 18 years.&#xD;
&#xD;
          -  Localized endometrial cancer (stage I and II); no evidence of stage III or IV disease.&#xD;
&#xD;
          -  At least 2 months was passed since the hysterectomy and enrollment.&#xD;
&#xD;
          -  Karnofsky performance status &gt; 70%.&#xD;
&#xD;
          -  Body mass index of 30.0 - 49.9 and body weight &lt; 300 pounds.&#xD;
&#xD;
          -  No plan for adjuvant endometrial cancer therapy.&#xD;
&#xD;
          -  Able to exercise safely on a treadmill.&#xD;
&#xD;
          -  No absolute contraindications to exercise testing as recommended by the American&#xD;
             Thoracic Society. No recent (&lt;6 months) acute cardiac event unstable angina,&#xD;
             uncontrolled dysrhythmias causing symptoms or hemodynamic compromise, symptomatic&#xD;
             aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus,&#xD;
             acute myocarditis or pericarditis, suspected or known dissecting aneurism and acute&#xD;
             systemic infection.&#xD;
&#xD;
          -  The subject is not participating in regular physical exercise (more than 60 minutes of&#xD;
             moderate intensity or 30 minutes of vigorous intensity exercise per week) or weight&#xD;
             reduction dieting.&#xD;
&#xD;
          -  Able to provide informed consent.&#xD;
&#xD;
          -  Have reliable transportation to the testing facilities.&#xD;
&#xD;
          -  Subjects must be able to speak and understand English to participate in this study.&#xD;
&#xD;
          -  Subjects must have a personal mobile device compatible for the activity monitor&#xD;
&#xD;
        Compatible devices for the activity monitors are below:&#xD;
&#xD;
          -  Android&#xD;
&#xD;
             o Activity monitor is compatible with most Android devices equipped with Bluetooth 4.0&#xD;
             and running Android 4.3 (Jelly Bean) or later.&#xD;
&#xD;
          -  iOS&#xD;
&#xD;
               -  iPhone 4s (or newer)&#xD;
&#xD;
               -  iPod touch (5th generation or newer)&#xD;
&#xD;
               -  iPad (3rd generation or newer)&#xD;
&#xD;
               -  iPad mini (1st generation or newer)&#xD;
&#xD;
               -  iPad Air (1st generation or newer)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Angeles A Secord, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Schwartz AR, Bartlett DB, Johnson JL, Broadwater G, Channell M, Nolte KC, Wilkes PA, Huffman KM, Secord AA. A Pilot Study of Home-Based Exercise and Personalized Nutrition Counseling Intervention in Endometrial Cancer Survivors. Front Oncol. 2021 Jun 11;11:669961. doi: 10.3389/fonc.2021.669961. eCollection 2021.</citation>
    <PMID>34178654</PMID>
  </results_reference>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>July 27, 2021</last_update_submitted>
  <last_update_submitted_qc>July 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometrial 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/NCT02987881
org study id: Pro00074542
nct id: NCT02987881
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will evaluate whether the use of the Jawbone wristband monitor, in connection with
      home-based exercise and nutritional counseling can be safely completed and improve
      cardiorespiratory fitness (heart and lung health) in women with early stage endometrial
      cancer who have undergone surgery.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
masking description: Open Label
measure: Feasibility as measured by adherence to weekly walking sessions
time frame: Week 12
description: Percentage of daily steps divided by total number of steps and daily walking sessions divided by total number of sessions prescribed
measure: Safety as measured by the type and prevalence of adverse events during study-related assessments
time frame: Week 12
description: Collection of events related to cardiopulmonary testing and self-reported events during off-site exercise training
measure: change in cardiorespiratory fitness and CVD risk profile as measured by VO2peak
time frame: baseline and 12 weeks
measure: change in cardiorespiratory fitness and CVD risk profile as measured by blood pressure
time frame: baseline and 12 weeks
measure: change in cardiorespiratory fitness and CVD risk profile as measured by lipid profile
time frame: baseline and 12 weeks
measure: change in cardiorespiratory fitness and CVD risk profile as measured by C-reactive protein
time frame: baseline and 12 weeks
measure: change in cardiorespiratory fitness and CVD risk profile as measured by body composition
time frame: baseline and 12 weeks
measure: patient experience with exercise and nutrition counseling as measured by telephone questionnaire
time frame: 16 weeks
arm group label: Adult women with early stage localized endometrial cancer
arm group type: Experimental
description: Adult women with early stage localized endometrial cancer at least 2 months following hysterectomy
intervention type: Behavioral
intervention name: Home-based aerobic exercise and nutritional counseling
description: Moderate walking and running with nutritional counseling at study visits.
arm group label: Adult women with early stage localized endometrial cancer
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Angeles A Secord, M.D.
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
citation: Schwartz AR, Bartlett DB, Johnson JL, Broadwater G, Channell M, Nolte KC, Wilkes PA, Huffman KM, Secord AA. A Pilot Study of Home-Based Exercise and Personalized Nutrition Counseling Intervention in Endometrial Cancer Survivors. Front Oncol. 2021 Jun 11;11:669961. doi: 10.3389/fonc.2021.669961. eCollection 2021.
PMID: 34178654
responsible party type: Sponsor
mesh term: Endometrial Neoplasms
sharing ipd: Undecided