<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/NCT02250053</url>
  </required_header>
  <id_info>
    <org_study_id>UPCC 10214</org_study_id>
    <nct_id>NCT02250053</nct_id>
  </id_info>
  <brief_title>Exercise and Colon Cancer</brief_title>
  <official_title>The COURAGE Trial: Colon Recurrence and Aerobic Exercise: A Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abramson Cancer Center at Penn Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abramson Cancer Center at Penn Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite the success of surgery and chemotherapy among people with colon cancer, 30-50% of&#xD;
      patients develop recurrent disease. Physical activity has emerged as a potential lifestyle&#xD;
      intervention to reduce cancer recurrence and improve survival among people with colon cancer&#xD;
      (CC). This pilot study aims to identify the dose-response effects of aerobic exercise on&#xD;
      molecular and cellular pathways associated with physical activity and CC outcomes among&#xD;
      patients with stage II and III CC.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2015</start_date>
  <completion_date type="Actual">January 15, 2016</completion_date>
  <primary_completion_date type="Actual">January 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>
    <intervention_model_description>exercise</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
  </study_design_info>
  <primary_outcome>
    <measure>1. The biological efficacy of aerobic exercise on soluble intercellular adhesion molecule-1 (sICAM-1), and soluble vascular adhesion molecule-1 (sVCAM-1) prognostic biomarkers.</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Exercise adherence, quantified as the percentage of total dose completed relative to the total dose prescribed during the six-month study;</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visceral adipose tissue and anthropometric measures at baseline and six-months;</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting insulin measured at baseline and six-months;</measure>
    <time_frame>six months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circulating tumor cells measured at baseline and six-months.</measure>
    <time_frame>six months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Stage II Colon Cancer</condition>
  <condition>Stage III Colon Cancer</condition>
  <arm_group>
    <arm_group_label>exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>aerobic exercise on soluble intercellular adhesion molecules</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <arm_group_label>exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. histologically confirmed TNM stage II-III CC;&#xD;
&#xD;
          2. completed surgical resection and adjuvant chemotherapy (if applicable) within 1-24&#xD;
             months before entering the study;&#xD;
&#xD;
          3. ≤120 min/wk of self-reported moderate or vigorous intensity physical activity using&#xD;
             the Paffenbarger physical activity questionnaire;&#xD;
&#xD;
          4. age ≥18 years;&#xD;
&#xD;
          5. written physician approval;&#xD;
&#xD;
          6. no additional surgery planned within the 6-month intervention (including colostomy&#xD;
             reversal);&#xD;
&#xD;
          7. ability to walk unaided for 6-minutes;&#xD;
&#xD;
          8. no contraindications to exercise using the PA readiness questionnaire (PAR-Q), unless&#xD;
             physician approves participation with specific knowledge of this contraindication.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. history of another primary invasive cancer (other than non-melanoma skin-cancer);&#xD;
&#xD;
          2. evidence of metastatic CC (i.e., TNM M1);&#xD;
&#xD;
          3. planning to receive any additional adjuvant chemotherapy;&#xD;
&#xD;
          4. pregnant or breast feeding;&#xD;
&#xD;
          5. unable to provide baseline blood sample;&#xD;
&#xD;
          6. cardiac conditions, including the following:&#xD;
&#xD;
               1. myocardial infarction or coronary revascularization procedure within prior 3&#xD;
                  months;&#xD;
&#xD;
               2. uncontrolled hypertension (systolic ≥180 mmHg or diastolic ≥100 mmHg);&#xD;
&#xD;
               3. high-risk or uncontrolled arrhythmias;&#xD;
&#xD;
               4. clinically significant valvular disease;&#xD;
&#xD;
               5. decompensated heart failure;&#xD;
&#xD;
               6. known aortic aneurysm;&#xD;
&#xD;
          7. any other condition that may impede testing of the study hypothesis or make it unsafe&#xD;
             to engage in the exercise program (determined by the investigative team).&#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>Kathryn Schmitz, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Abramson Cancer Center at Penn Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Abramson Cancer Center of the University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>April 7, 2020</last_update_submitted>
  <last_update_submitted_qc>April 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>stage II and stage III colon cancer survivors, who have completed curative treatment i.e., surgical resection and chemotherapy for their colon cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic 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/NCT02250053
org study id: UPCC 10214
nct id: NCT02250053
lead sponsor: 
has dmc: Yes
Despite the success of surgery and chemotherapy among people with colon cancer, 30-50% of
      patients develop recurrent disease. Physical activity has emerged as a potential lifestyle
      intervention to reduce cancer recurrence and improve survival among people with colon cancer
      (CC). This pilot study aims to identify the dose-response effects of aerobic exercise on
      molecular and cellular pathways associated with physical activity and CC outcomes among
      patients with stage II and III CC.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: exercise
primary purpose: Treatment
measure: 1. The biological efficacy of aerobic exercise on soluble intercellular adhesion molecule-1 (sICAM-1), and soluble vascular adhesion molecule-1 (sVCAM-1) prognostic biomarkers.
time frame: 2 years
measure: Exercise adherence, quantified as the percentage of total dose completed relative to the total dose prescribed during the six-month study;
time frame: 6 months
measure: Visceral adipose tissue and anthropometric measures at baseline and six-months;
time frame: 6 months
measure: Fasting insulin measured at baseline and six-months;
time frame: six months
measure: Circulating tumor cells measured at baseline and six-months.
time frame: six months
arm group label: exercise
arm group type: Experimental
description: aerobic exercise on soluble intercellular adhesion molecules
intervention type: Other
intervention name: Exercise
arm group label: exercise
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kathryn Schmitz, PhD
role: Principal Investigator
affiliation: Abramson Cancer Center at Penn Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Colonic Neoplasms