<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/NCT01727570</url>
  </required_header>
  <id_info>
    <org_study_id>11-240-SDR</org_study_id>
    <nct_id>NCT01727570</nct_id>
  </id_info>
  <brief_title>Prehabilitation to Overcome the Stress of Surgery: the Role of Nutrition in Enhancing Postoperative Functional Capacity</brief_title>
  <official_title>Prehabilitation to Overcome the Stress of Surgery: the Role of Nutrition in Enhancing Postoperative Functional Capacity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Franco Carli</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Immunotec Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>McGill University Health Centre/Research Institute of the McGill University Health Centre</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine the impact of nutritional supplementation with whey protein on postoperative&#xD;
      functional capacity in patients undergoing colorectal surgery for cancer.It is hypothesized&#xD;
      that, compared with a control group receiving nutrition counselling only, patients receiving&#xD;
      nutritional counselling along with preoperative and postoperative nutritional supplements&#xD;
      will have a significantly improved change in functional walking capacity from baseline to 8&#xD;
      weeks after surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aims of this research project are the following:&#xD;
&#xD;
        1. Determine to what extent a nutritional prehabilitation regimen, which includes whey&#xD;
           protein, initiated before surgery and continued after surgery, optimizes the recovery of&#xD;
           functional walking capacity following colorectal resection for cancer.&#xD;
&#xD;
        2. To understand further which measures of immediate surgical recovery are sensitive to&#xD;
           prehabilitation interventions, and predict change in later outcome measures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">October 2013</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>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Six-Minute Walk Test (6MWT)</measure>
    <time_frame>up to 8 weeks after surgery</time_frame>
    <description>Change in functional walking capacity will be assessed throughout the study according to the 6-Minute Walk Test (6MWT). The 6MWT evaluates the ability of an individual to maintain a moderate level of physical activity over a time period reflective of the activities of daily living. Subjects are instructed to walk back and forth, in a 20 m stretch of hallway, for six minutes, at a pace that would make them tired by the end of the walk; encouragement and feedback are given according to published guidelines.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Nutrition Counselling</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will be asked to fill out a three day record of all food and drink consumed. Patients will be given an appointment with the nutritionist approximately 4 weeks before surgery to go over their regular diet and advice will be given on how to improve the nutritional quality of their diet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nutrition Supplementation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will be asked to fill out a three day record of all food and drink consumed. An appointment with the nutritionist will be given approximately 4 weeks before surgery to go over their regular diet and advice will be given on how to improve the nutritional quality of the diet. Patients will also be given a supply of nutritional supplements to take orally (by mouth) every day. These supplements include a whey protein isolate (Immunocal®, Immunotec Inc), omega-3 fatty acids from fish oil, and vitamins/minerals.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Whey Protein (Immunocal®)</intervention_name>
    <description>The amount of Immunocal® whey protein the patient is required to take daily will be determined on an individual basis by the nutritionist according to the assessed protein deficit in the patient's diet.</description>
    <arm_group_label>Nutrition Supplementation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  +18 years of age&#xD;
&#xD;
          -  referred electively for resection of malignant, non metastasized, colorectal lesions&#xD;
&#xD;
          -  French or English speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA class 4-5&#xD;
&#xD;
          -  co-morbid medical, physical and mental conditions (e.g.dementia, disabling orthopedic&#xD;
             and neuromuscular disease, psychosis)&#xD;
&#xD;
          -  cardiac abnormalities&#xD;
&#xD;
          -  severe end-organ disease such as cardiac failure (New York Heart Association classes&#xD;
             I-IV), COPD, renal failure (creatinine &gt; 1.5 mg/dl, and hepatic failure ALT and AST&#xD;
             &gt;50% over the normal range)&#xD;
&#xD;
          -  sepsis&#xD;
&#xD;
          -  morbid obesity (BMI &gt;40)&#xD;
&#xD;
          -  anemia (hematocrit &lt; 30 %, haemoglobin &lt;10g/dl, albumin &lt; 25mg/dl).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Franco Carli, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McGill University Health Centre/Research Institute of the McGill University Health Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Montreal General Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3H2R9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <last_update_submitted>November 18, 2014</last_update_submitted>
  <last_update_submitted_qc>November 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>McGill University Health Centre/Research Institute of the McGill University Health Centre</investigator_affiliation>
    <investigator_full_name>Franco Carli</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Cancer</keyword>
  <keyword>Colon</keyword>
  <keyword>Rectum</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/NCT01727570
org study id: 11-240-SDR
nct id: NCT01727570
lead sponsor: 
collaborator: 
has dmc: Yes
To determine the impact of nutritional supplementation with whey protein on postoperative
      functional capacity in patients undergoing colorectal surgery for cancer.It is hypothesized
      that, compared with a control group receiving nutrition counselling only, patients receiving
      nutritional counselling along with preoperative and postoperative nutritional supplements
      will have a significantly improved change in functional walking capacity from baseline to 8
      weeks after surgery.
The aims of this research project are the following:

        1. Determine to what extent a nutritional prehabilitation regimen, which includes whey
           protein, initiated before surgery and continued after surgery, optimizes the recovery of
           functional walking capacity following colorectal resection for cancer.

        2. To understand further which measures of immediate surgical recovery are sensitive to
           prehabilitation interventions, and predict change in later outcome measures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Six-Minute Walk Test (6MWT)
time frame: up to 8 weeks after surgery
description: Change in functional walking capacity will be assessed throughout the study according to the 6-Minute Walk Test (6MWT). The 6MWT evaluates the ability of an individual to maintain a moderate level of physical activity over a time period reflective of the activities of daily living. Subjects are instructed to walk back and forth, in a 20 m stretch of hallway, for six minutes, at a pace that would make them tired by the end of the walk; encouragement and feedback are given according to published guidelines.
arm group label: Nutrition Counselling
arm group type: No Intervention
description: Patients will be asked to fill out a three day record of all food and drink consumed. Patients will be given an appointment with the nutritionist approximately 4 weeks before surgery to go over their regular diet and advice will be given on how to improve the nutritional quality of their diet
arm group label: Nutrition Supplementation
arm group type: Active Comparator
description: Patients will be asked to fill out a three day record of all food and drink consumed. An appointment with the nutritionist will be given approximately 4 weeks before surgery to go over their regular diet and advice will be given on how to improve the nutritional quality of the diet. Patients will also be given a supply of nutritional supplements to take orally (by mouth) every day. These supplements include a whey protein isolate (Immunocal®, Immunotec Inc), omega-3 fatty acids from fish oil, and vitamins/minerals.
intervention type: Dietary Supplement
intervention name: Whey Protein (Immunocal®)
description: The amount of Immunocal® whey protein the patient is required to take daily will be determined on an individual basis by the nutritionist according to the assessed protein deficit in the patient's diet.
arm group label: Nutrition Supplementation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Franco Carli, MD
role: Principal Investigator
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
facility: 
country: Canada
responsible party type: Sponsor-Investigator
investigator affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
investigator full name: Franco Carli
investigator title: MD
mesh term: Colorectal Neoplasms