<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/NCT02235441</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00055718</org_study_id>
    <nct_id>NCT02235441</nct_id>
  </id_info>
  <brief_title>Effects of Chemoradiation and Surgery on Cardiopulmonary Fitness and Tumor Neoplastic Phenotype in Gastrointestinal Malignancies</brief_title>
  <official_title>Effects of Chemoradiation and Surgery on Cardiopulmonary Fitness and Tumor Neoplastic Phenotype in Gastrointestinal Malignancies: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is growing evidence of the integral role of exercise following cancer treatment.&#xD;
      Randomized trials show that exercise improves post treatment symptoms and quality of life in&#xD;
      breast and prostate cancer patients.Regular exercise reduces cancer specific and all cause&#xD;
      mortality for patients with breast, prostate, brain or colorectal cancer. Nearly a 40-50%&#xD;
      relative risk reduction in cancer specific death and 20-50% relative risk reduction in all&#xD;
      cause mortality have been reported with exercise. At present it is unknown if preclinical&#xD;
      pleiotropic effects on tumors through aerobic exercise are clinically relevant. Before&#xD;
      launching into further studies of exercise training on changes in tumor hypoxia and response&#xD;
      to CRT in rectal cancer patients, it is first important to understand: 1. Whether measures of&#xD;
      exercise exposure (i.e., exercise capacity and self-reported exercise behavior) are&#xD;
      associated with markers of tumor hypoxia at diagnosis (prior to initiation of CRT) and 2.&#xD;
      Whether changes in measures of exercise exposure over the course of CRT are related to&#xD;
      changes in tumor hypoxia and response to CRT.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">April 5, 2016</completion_date>
  <primary_completion_date type="Actual">April 5, 2016</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>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility Composite Score</measure>
    <time_frame>36 months</time_frame>
    <description>The primary objective is to determine the feasibility of assessing cardiopulmonary fitness pre and post chemoradiation therapy. This feasibility assessment will be reported as a composite of the following variables: (a) the study can accrue 25 patients in no more than 3 years, (b) at least 18 of these 25 patients adhere to the cardiopulmonary testing pre and post CRT; do not drop out early, and do not have an exercise-related adverse event (i.e., cardiac arrhythmias or myocardial infarction), and (c) no more than 1 patient has an exercise-related adverse event.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Pathologically Proven Gastrointestinal Malignancy</condition>
  <condition>Plan of Care Must Include Chemoradiation</condition>
  <arm_group>
    <arm_group_label>Cardiopulmonary Fitness</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All eligible subjects will participate in treadmill exercise to measure cardiopulmonary fitness during chemoradiation therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cardiopulmonary Exercise Test (CPET)</intervention_name>
    <description>All subjects will undergo a maximal cardiopulmonary exercise test and resting metabolic rate study. Prior to the exercise treadmill test, each subject will have a resting ECG and blood pressure to determine whether there are any abnormalities that would contraindicate exercise testing.This exercise test involves exercising on a treadmill to maximal exertion, during which the subject's breathing and oxygen consumption are measured. The subject will wear nose clips to prevent exhaling air through their nose and a mouth piece that will allow all exhaled air to be analyzed through the metabolic cart. The subject's electrocardiogram (ECG), blood pressure, and perceived exertion are monitored throughout the test by trained personnel.</description>
    <arm_group_label>Cardiopulmonary Fitness</arm_group_label>
    <other_name>Treadmill exercise</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically confirmed gastrointestinal malignancy&#xD;
&#xD;
          2. Plan for chemoradiation&#xD;
&#xD;
          3. At least 18 years old&#xD;
&#xD;
          4. Karnofsky performance status of at least 70% at study entry&#xD;
&#xD;
          5. Ability to read and understand English&#xD;
&#xD;
          6. Signed informed consent prior to initiation of study-related procedures&#xD;
&#xD;
          7. All women of childbearing potential must have a negative serum pregnancy test prior to&#xD;
             study entry&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Significant cardiac disease (i.e., left ventricular ejection fraction of &lt;50%,&#xD;
             unstable angina, placement of cardiac stents and myocardial infarction within previous&#xD;
             6 months)&#xD;
&#xD;
          2. Contraindications to a cardiopulmonary exercise test as recommended by the American&#xD;
             Thoracic Society: (a) acute myocardial infarction (3-5 days), (b) unstable angina, (c)&#xD;
             uncontrolled arrhythmias causing symptoms or hemodynamic compromise, (d) syncope, (e)&#xD;
             acute endocarditis, (f) acute myocarditis or pericarditis, (g) uncontrolled heart&#xD;
             failure, (h) acute pulmonary embolus or pulmonary infarction, (i) thrombosis of lower&#xD;
             extremities, (j) suspected dissecting aneurysm, (k) uncontrolled asthma, (l) pulmonary&#xD;
             edema, (m) room air desaturation at rest ≤85%, (n) respiratory failure, (o) acute&#xD;
             noncardiopulmonary disorder that may affect exercise performance or be aggravated by&#xD;
             exercise, (p) mental impairment leading to inability to cooperate, and (q) extensive&#xD;
             bone metastases&#xD;
&#xD;
          3. KPS&lt;70%&#xD;
&#xD;
          4. Females who are pregnant&#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>Manisha Palta, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Joan Cahill</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>July 7, 2017</last_update_submitted>
  <last_update_submitted_qc>July 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gastrointestinal malignancy</keyword>
  <keyword>Cardiopulmonary fitness</keyword>
  <keyword>Chemoradiation therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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/NCT02235441
org study id: Pro00055718
nct id: NCT02235441
lead sponsor: 
has dmc: No
There is growing evidence of the integral role of exercise following cancer treatment.
      Randomized trials show that exercise improves post treatment symptoms and quality of life in
      breast and prostate cancer patients.Regular exercise reduces cancer specific and all cause
      mortality for patients with breast, prostate, brain or colorectal cancer. Nearly a 40-50%
      relative risk reduction in cancer specific death and 20-50% relative risk reduction in all
      cause mortality have been reported with exercise. At present it is unknown if preclinical
      pleiotropic effects on tumors through aerobic exercise are clinically relevant. Before
      launching into further studies of exercise training on changes in tumor hypoxia and response
      to CRT in rectal cancer patients, it is first important to understand: 1. Whether measures of
      exercise exposure (i.e., exercise capacity and self-reported exercise behavior) are
      associated with markers of tumor hypoxia at diagnosis (prior to initiation of CRT) and 2.
      Whether changes in measures of exercise exposure over the course of CRT are related to
      changes in tumor hypoxia and response to CRT.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Feasibility Composite Score
time frame: 36 months
description: The primary objective is to determine the feasibility of assessing cardiopulmonary fitness pre and post chemoradiation therapy. This feasibility assessment will be reported as a composite of the following variables: (a) the study can accrue 25 patients in no more than 3 years, (b) at least 18 of these 25 patients adhere to the cardiopulmonary testing pre and post CRT; do not drop out early, and do not have an exercise-related adverse event (i.e., cardiac arrhythmias or myocardial infarction), and (c) no more than 1 patient has an exercise-related adverse event.
arm group label: Cardiopulmonary Fitness
arm group type: Experimental
description: All eligible subjects will participate in treadmill exercise to measure cardiopulmonary fitness during chemoradiation therapy.
intervention type: Other
intervention name: Cardiopulmonary Exercise Test (CPET)
description: All subjects will undergo a maximal cardiopulmonary exercise test and resting metabolic rate study. Prior to the exercise treadmill test, each subject will have a resting ECG and blood pressure to determine whether there are any abnormalities that would contraindicate exercise testing.This exercise test involves exercising on a treadmill to maximal exertion, during which the subject's breathing and oxygen consumption are measured. The subject will wear nose clips to prevent exhaling air through their nose and a mouth piece that will allow all exhaled air to be analyzed through the metabolic cart. The subject's electrocardiogram (ECG), blood pressure, and perceived exertion are monitored throughout the test by trained personnel.
arm group label: Cardiopulmonary Fitness
other name: Treadmill exercise
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Manisha Palta, MD
role: Principal Investigator
affiliation: Duke Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms