<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/NCT02987296</url>
  </required_header>
  <id_info>
    <org_study_id>20160732-01H</org_study_id>
    <nct_id>NCT02987296</nct_id>
  </id_info>
  <brief_title>Perioperative Immunonutrition in Colorectal Cancer Patients Undergoing Abdominal Surgery</brief_title>
  <acronym>PERIOP-02</acronym>
  <official_title>A Translational Clinical Trial of Perioperative Immunonutrition in Colorectal Cancer Patients Undergoing Abdominal Surgery: PERIOP-02</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ottawa Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ottawa Hospital Research Institute</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The immune system plays an important role in helping to kill and prevent cancers. Cells of&#xD;
      the immune system, such as natural killer (NK) cells and T cells, do not work as well&#xD;
      following surgery. Arginine, an amino acid, is fundamental in metabolic processes of the&#xD;
      body. Surgery has shown to cause a reduction of arginine in the body. In turn, this&#xD;
      deficiency causes NK cell suppression. In this study, we want to look at the effects of&#xD;
      arginine supplementation before and after surgery on NK cell function in surgery patients. In&#xD;
      this study, we will be using a nutritional supplement containing arginine and a placebo drink&#xD;
      (provided by Enhanced Medical Nutrition) that will be taken by colorectal cancer patients 5&#xD;
      days before surgery and 5 days after surgery. Using patient blood samples, we will measure NK&#xD;
      cell levels, arginine levels and also arginase activity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">July 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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>NK cell killing as measured on peripheral blood mononuclear cells (PBMC) between the control (placebo) and experimental cohorts, using a standard NK cell killing assay.</measure>
    <time_frame>Baseline (before surgery), post-operative day 1</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Decrease in postoperative serum arginine levels between the control (placebo) and experimental cohorts</measure>
    <time_frame>Baseline (before surgery), post-operative day 1, 3, 5 and 35</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance with perioperative arginine supplementation</measure>
    <time_frame>5 days preoperatively to 5 days postoperatively</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>ColoRectal Cancer</condition>
  <arm_group>
    <arm_group_label>Immunonutrition with arginine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive the nutritional supplement for 5 days prior to surgery and for 5 days after. The drink will contain arginine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Immunonutrition without arginine</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>This group of patients will also receive a nutritional drink but containing no arginine for 5 days before surgery and for 5 days after surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Immunonutrition with arginine</intervention_name>
    <description>Nutritional beverage containing supplemental arginine taken 3 times per day</description>
    <arm_group_label>Immunonutrition with arginine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Immunonutrition without Arginine</intervention_name>
    <description>Nutritional beverage without supplemental arginine taken 3 times per day</description>
    <arm_group_label>Immunonutrition without arginine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a diagnosis of a primary colorectal cancer and eligible for surgical&#xD;
             resection.&#xD;
&#xD;
          -  Patients &gt; 18 years of age&#xD;
&#xD;
          -  Eligible patients must have signed a consent for surgical resection of the malignancy.&#xD;
&#xD;
          -  Ability to understand and provide a signed informed consent form (ICF) approved by the&#xD;
             Research ethics board (REB).&#xD;
&#xD;
          -  Adequate kidney function with Creatine clearance&gt;30mL/min&#xD;
&#xD;
          -  Hemoglobin level &gt;90 mg/dL&#xD;
&#xD;
          -  Ability to comply with protocol requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior adjuvant chemotherapy or radiation within 8 weeks of planned surgery.&#xD;
&#xD;
          -  Documented significant immunodeficiency due to underlying illness (e.g. HIV/AIDS)&#xD;
             and/or medication (e.g. systemic corticosteroids, azathioprine, cyclosporin A).&#xD;
             Subjects may be on physiologic doses of replacement prednisone or equivalent doses of&#xD;
             corticosteroid (&lt;7.5 mg daily).&#xD;
&#xD;
          -  Subjects with resting hypotension (Blood pressure &lt;90/50 at rest).&#xD;
&#xD;
          -  History of autoimmune disease, such as but not restricted to, inflammatory bowel&#xD;
             disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or&#xD;
             multiple sclerosis.&#xD;
&#xD;
          -  Serious intercurrent chronic or acute illness, or other illness considered by the&#xD;
             investigator as an unwarranted high risk for an investigational product.&#xD;
&#xD;
          -  Active infection of any site and/or active herpes requiring ongoing treatment&#xD;
&#xD;
          -  Known pregnancy or nursing mothers&#xD;
&#xD;
          -  Subjects with a fish allergy.&#xD;
&#xD;
          -  Subjects with severe asthma defined as asthma not controlled with inhaled&#xD;
             corticosteroids and additional controllers or by oral corticosteroid treatment&#xD;
             (arginine can cause allergic response or make swelling in airways worse).&#xD;
&#xD;
          -  Subjects with a known inherited guanidinoacetate methyltransferase deficiency (due to&#xD;
             an inability to convert arginine to creatine)&#xD;
&#xD;
          -  Subject with known history of liver cirrhosis&#xD;
&#xD;
          -  Subjects who have who have suffered a myocardial infarction or life-threatening&#xD;
             arrhythmia within the last 6 months&#xD;
&#xD;
          -  Subjects with cardiac failure or coronary artery disease causing unstable angina&#xD;
&#xD;
          -  Subjects with a medical or psychological impediment to probable compliance with the&#xD;
             protocol should be excluded.&#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>Rebecca C Auer, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ottawa Hospital Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Ottawa Hospital</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>October 25, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>September 3, 2019</last_update_submitted>
  <last_update_submitted_qc>September 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Colorectal Cancer</keyword>
  <keyword>Surgery</keyword>
  <keyword>Arginine depletion</keyword>
  <keyword>Immune system dysfunction</keyword>
  <keyword>Arginine Supplementation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT02987296
org study id: 20160732-01H
nct id: NCT02987296
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The immune system plays an important role in helping to kill and prevent cancers. Cells of
      the immune system, such as natural killer (NK) cells and T cells, do not work as well
      following surgery. Arginine, an amino acid, is fundamental in metabolic processes of the
      body. Surgery has shown to cause a reduction of arginine in the body. In turn, this
      deficiency causes NK cell suppression. In this study, we want to look at the effects of
      arginine supplementation before and after surgery on NK cell function in surgery patients. In
      this study, we will be using a nutritional supplement containing arginine and a placebo drink
      (provided by Enhanced Medical Nutrition) that will be taken by colorectal cancer patients 5
      days before surgery and 5 days after surgery. Using patient blood samples, we will measure NK
      cell levels, arginine levels and also arginase activity.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: NK cell killing as measured on peripheral blood mononuclear cells (PBMC) between the control (placebo) and experimental cohorts, using a standard NK cell killing assay.
time frame: Baseline (before surgery), post-operative day 1
measure: Decrease in postoperative serum arginine levels between the control (placebo) and experimental cohorts
time frame: Baseline (before surgery), post-operative day 1, 3, 5 and 35
measure: Compliance with perioperative arginine supplementation
time frame: 5 days preoperatively to 5 days postoperatively
arm group label: Immunonutrition with arginine
arm group type: Active Comparator
description: Patients will receive the nutritional supplement for 5 days prior to surgery and for 5 days after. The drink will contain arginine.
arm group label: Immunonutrition without arginine
arm group type: Placebo Comparator
description: This group of patients will also receive a nutritional drink but containing no arginine for 5 days before surgery and for 5 days after surgery.
intervention type: Dietary Supplement
intervention name: Immunonutrition with arginine
description: Nutritional beverage containing supplemental arginine taken 3 times per day
arm group label: Immunonutrition with arginine
intervention type: Dietary Supplement
intervention name: Immunonutrition without Arginine
description: Nutritional beverage without supplemental arginine taken 3 times per day
arm group label: Immunonutrition without arginine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rebecca C Auer, MD, MSc
role: Principal Investigator
affiliation: Ottawa Hospital Research Institute
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
sharing ipd: Yes