<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/NCT02264496</url>
  </required_header>
  <id_info>
    <org_study_id>13/YH/0322 V3</org_study_id>
    <nct_id>NCT02264496</nct_id>
  </id_info>
  <brief_title>Prospective Randomised Trial of Exercise and / or Antioxidants in COlorectal Cancer Patients Undergoing Surgery.</brief_title>
  <acronym>PEACOCS</acronym>
  <official_title>The Effects of Exercise on Outcomes in Patients Undergoing Surgery for Colorectal Cancer: a Pilot Prospective Randomised Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hull University Teaching Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Hull</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hull University Teaching Hospitals NHS Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Colorectal cancer is the fourth most common cancer in the UK. Surgical resection is the&#xD;
      mainstay of curative therapy. With the screening program enabling early detection, surgery&#xD;
      plays an important role in treatment strategies. Surgery imparts a significant physiological&#xD;
      and psychological stress on cancer patients.Recent research has demonstrated that a&#xD;
      fast-track approach utilising regional anaesthesia, early mobilisation and good oral intake&#xD;
      can improve outcomes by reducing the physiological stress response to surgery. The primary&#xD;
      objective of this study is to determine whether a defined exercise programme can improve&#xD;
      recovery and reduce complications after surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Design&#xD;
&#xD;
      This will be a prospective and randomised pilot clinical trial. For purposes of pragmatism,&#xD;
      subjects and investigators will not be blinded to treatment allocation. The study is not&#xD;
      blinded because it is impossible to blind investigators or patients to the exercise&#xD;
      programme.&#xD;
&#xD;
      Patients undergoing major resectional surgery for colorectal cancer will be recruited from&#xD;
      the Academic Surgical unit (ASU), Castle Hill Hospital. In total, 60 participants will be&#xD;
      recruited for this pilot study and randomly allocated into 2 groups as outlined below.&#xD;
&#xD;
      The study will necessitate all participants being involved in a baseline assessment which&#xD;
      will take on average 60 minutes with patients attending Castle Hill Hospital. Travel costs&#xD;
      will be met.&#xD;
&#xD;
      All participants will be asked for a 15 ml blood samples on entry into the study and at 24-48&#xD;
      hrs prior to surgery. Regardless of recruitment, blood samples are necessary for clinical&#xD;
      purposes at these stages in all patients as part of routine preoperative assessment prior to&#xD;
      colorectal surgery. The aim of this is to permit an analysis of possible changes in&#xD;
      antioxidant status prior to surgery but after preconditioning. This would be in addition to&#xD;
      routine blood samples required.&#xD;
&#xD;
      The two groups in this study are described in more detail below. Both groups shall receive&#xD;
      the same standard care as is normal for patients undergoing colorectal resection surgery. The&#xD;
      only difference between groups shall be the addition of exercise preconditioning sessions to&#xD;
      group 1. We anticipate that these will be three times a week and lasting of 60-90 minutes&#xD;
      duration each. Travel costs will be met.&#xD;
&#xD;
      Groups&#xD;
&#xD;
      The 60 patients in this study will be randomised to one of two groups as follows:&#xD;
&#xD;
        -  Group 1 - Standard care + Exercise intervention. Patients in this group will participate&#xD;
           in a 2-4 week low volume, moderate intensity, supervised, one to one, individualised&#xD;
           exercise programme.&#xD;
&#xD;
        -  Group 2 - Standard care (Control) group. These patients will not be entered into a&#xD;
           supervised exercise programme.&#xD;
&#xD;
      Research hypothesis 1&#xD;
&#xD;
      H0 - A two to four week period of low to moderate intensity exercise prior to surgery using&#xD;
      an individualised exercise intervention will not reduce post-surgical length of hospital stay&#xD;
      in colorectal cancer patients.&#xD;
&#xD;
      H1- A two to four week period of low to moderate intensity exercise prior to surgery using an&#xD;
      individualised exercise intervention will reduce post-surgical length of hospital stay in&#xD;
      colorectal cancer patients.&#xD;
&#xD;
      Research hypothesis 2&#xD;
&#xD;
      H0 - A two to four week period of low to moderate intensity exercise prior to surgery using&#xD;
      an individualised exercise intervention will not modify the body's defence systems against a&#xD;
      future oxidative stress.&#xD;
&#xD;
      H1- A two to four week period of low to moderate intensity exercise prior to surgery using an&#xD;
      individualised exercise intervention will modify the body's defence systems against a future&#xD;
      oxidative stress.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Length of stay</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>Post-operative hospital length of stay until medically fit for discharge.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Antioxidant capacity</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Biochemical markers of antioxidant capacity: Hsp 32/72, CD11b/CD18 and Glutathione measured pre- and post-intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exercise capacity</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>Exercise test and CPEX parameters assessed pre-intervention, post-intervention and at 3 months post surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>All post-operative complications assessed at 3 months post surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Questionnaires</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>Validated QOL questionnaires completed pre-intervention, post-intervention and at 3 months post surgery.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard pre-operative care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A 2-4 week low volume, moderate intensity, supervised, one to one, individualised exercise programme. '</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <arm_group_label>Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients with colorectal cancer listed for elective resection surgery who have&#xD;
             consented to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of unstable angina/unstable coronary artery disease or a heart attack in the&#xD;
             previous month&#xD;
&#xD;
          -  Any heart related disease including but not limited to aortic stenosis, pericarditis&#xD;
             or any thromboembolic disease&#xD;
&#xD;
          -  Severe Infections and fever&#xD;
&#xD;
          -  Uncontrolled metabolic diseases&#xD;
&#xD;
          -  Uncontrolled asthma&#xD;
&#xD;
          -  Acute non-cardiopulmonary disorder that may affect exercise performance or be&#xD;
             aggravated by exercise&#xD;
&#xD;
          -  Resting heart rate of more than 120 BPM&#xD;
&#xD;
          -  Systolic blood pressure of more than 180 mm Hg or diastolic blood pressure of more&#xD;
             than 110 mm Hg&#xD;
&#xD;
          -  Recent cerebrovascular accident&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Preexisting severe physical disability&#xD;
&#xD;
          -  Age &lt;18 years&#xD;
&#xD;
          -  Unwilling to allow their GP to be informed of their participation in the study&#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>John Hartley, MD FRCS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hull and East Yorkshire NHS Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Academic Surgical Unit, Castle Hill Hospital</name>
      <address>
        <city>Hull</city>
        <state>East Yorkshire</state>
        <zip>HU16 5JQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>October 7, 2014</study_first_submitted>
  <study_first_submitted_qc>October 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>July 11, 2019</last_update_submitted>
  <last_update_submitted_qc>July 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Colorectal cancer</keyword>
  <keyword>Exercise</keyword>
  <keyword>CPEX</keyword>
  <keyword>Exercise, Physical</keyword>
  <keyword>Exercise, Aerobic</keyword>
  <keyword>Surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal 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/NCT02264496
org study id: 13/YH/0322 V3
nct id: NCT02264496
lead sponsor: 
collaborator: 
has dmc: No
Colorectal cancer is the fourth most common cancer in the UK. Surgical resection is the
      mainstay of curative therapy. With the screening program enabling early detection, surgery
      plays an important role in treatment strategies. Surgery imparts a significant physiological
      and psychological stress on cancer patients.Recent research has demonstrated that a
      fast-track approach utilising regional anaesthesia, early mobilisation and good oral intake
      can improve outcomes by reducing the physiological stress response to surgery. The primary
      objective of this study is to determine whether a defined exercise programme can improve
      recovery and reduce complications after surgery.
Study Design

      This will be a prospective and randomised pilot clinical trial. For purposes of pragmatism,
      subjects and investigators will not be blinded to treatment allocation. The study is not
      blinded because it is impossible to blind investigators or patients to the exercise
      programme.

      Patients undergoing major resectional surgery for colorectal cancer will be recruited from
      the Academic Surgical unit (ASU), Castle Hill Hospital. In total, 60 participants will be
      recruited for this pilot study and randomly allocated into 2 groups as outlined below.

      The study will necessitate all participants being involved in a baseline assessment which
      will take on average 60 minutes with patients attending Castle Hill Hospital. Travel costs
      will be met.

      All participants will be asked for a 15 ml blood samples on entry into the study and at 24-48
      hrs prior to surgery. Regardless of recruitment, blood samples are necessary for clinical
      purposes at these stages in all patients as part of routine preoperative assessment prior to
      colorectal surgery. The aim of this is to permit an analysis of possible changes in
      antioxidant status prior to surgery but after preconditioning. This would be in addition to
      routine blood samples required.

      The two groups in this study are described in more detail below. Both groups shall receive
      the same standard care as is normal for patients undergoing colorectal resection surgery. The
      only difference between groups shall be the addition of exercise preconditioning sessions to
      group 1. We anticipate that these will be three times a week and lasting of 60-90 minutes
      duration each. Travel costs will be met.

      Groups

      The 60 patients in this study will be randomised to one of two groups as follows:

        -  Group 1 - Standard care + Exercise intervention. Patients in this group will participate
           in a 2-4 week low volume, moderate intensity, supervised, one to one, individualised
           exercise programme.

        -  Group 2 - Standard care (Control) group. These patients will not be entered into a
           supervised exercise programme.

      Research hypothesis 1

      H0 - A two to four week period of low to moderate intensity exercise prior to surgery using
      an individualised exercise intervention will not reduce post-surgical length of hospital stay
      in colorectal cancer patients.

      H1- A two to four week period of low to moderate intensity exercise prior to surgery using an
      individualised exercise intervention will reduce post-surgical length of hospital stay in
      colorectal cancer patients.

      Research hypothesis 2

      H0 - A two to four week period of low to moderate intensity exercise prior to surgery using
      an individualised exercise intervention will not modify the body's defence systems against a
      future oxidative stress.

      H1- A two to four week period of low to moderate intensity exercise prior to surgery using an
      individualised exercise intervention will modify the body's defence systems against a future
      oxidative stress.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Length of stay
time frame: Up to 3 months
description: Post-operative hospital length of stay until medically fit for discharge.
measure: Antioxidant capacity
time frame: Up to 4 weeks
description: Biochemical markers of antioxidant capacity: Hsp 32/72, CD11b/CD18 and Glutathione measured pre- and post-intervention.
measure: Exercise capacity
time frame: Up to 3 months
description: Exercise test and CPEX parameters assessed pre-intervention, post-intervention and at 3 months post surgery.
measure: Complications
time frame: Up to 3 months
description: All post-operative complications assessed at 3 months post surgery.
measure: Quality of Life Questionnaires
time frame: Up to 3 months
description: Validated QOL questionnaires completed pre-intervention, post-intervention and at 3 months post surgery.
arm group label: Control
arm group type: No Intervention
description: Standard pre-operative care
arm group label: Exercise
arm group type: Experimental
description: A 2-4 week low volume, moderate intensity, supervised, one to one, individualised exercise programme. '
intervention type: Behavioral
intervention name: Exercise
arm group label: Exercise
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John Hartley, MD FRCS
role: Principal Investigator
affiliation: Hull and East Yorkshire NHS Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Colorectal Neoplasms