xml: <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/NCT05999370</url>
    </required_header>
    <id_info>
      <org_study_id>37-2021-6990</org_study_id>
      <nct_id>NCT05999370</nct_id>
    </id_info>
    <brief_title>Prehabilitation for Colorectal Cancer Patients With Low Functional Capacity and Malnutrition</brief_title>
    <official_title>Is Correction of Malnutrition Sufficient to Improve Low Physical Function Before Elective Colorectal Cancer Surgery? A Randomized Controlled Trial of Nutrition vs Nutrition and Exercise Prehabilitation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>McGill University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>McGill University Health Centre/Research Institute of the McGill University Health Centre</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>McGill University</source>
    <oversight_info>
      <has_dmc>No</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>
        Despite multi-modal prehabilitation (nutrition, exercise, and psychosocial interventions),&#xD;
        60% of older elective colorectal cancer surgery patients with poor physical function were&#xD;
        unable to reach a minimum preoperative 400m six-minute walking distance (6MWD), a prognostic&#xD;
        cut-point. Compared to the patients that attained &gt;400m 6MWD preoperatively, twice as many of&#xD;
        &lt;400m patients were malnourished. Malnutrition has long been associated with worse&#xD;
        functioning (e.g., physical, immune). The investigators hypothesize that for nutritionally&#xD;
        deficient patients, the etiology for their poor physical function is malnutrition. Correction&#xD;
        of malnutrition alone might thus be sufficient to achieve a 400m 6MWD before surgery and&#xD;
        improve patient outcomes.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The investigators propose a randomized controlled trial of nutrition prehabilitation alone vs&#xD;
        nutrition prehabilitation with supportive exercise in patients with malnutrition and 6MWD&#xD;
        &lt;400m before elective colorectal surgery. The primary objective, and therapeutic target, will&#xD;
        be achievement of minimal clinical important difference for the 6MWD (14m for within group&#xD;
        comparisons and 19m between groups). Ability to adhere to the interventions will be&#xD;
        monitored. The findings of this study will guide optimal treatment for this vulnerable&#xD;
        population by exploring the role of nutrition alone vs. nutrition with exercise to optimize&#xD;
        surgical outcomes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 31, 2022</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2025</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>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Preoperative six-minute walking distance</measure>
      <time_frame>from date of baseline assessment until date of surgery, an average of 4 weeks, recorded in meters</time_frame>
      <description>Physical function will be measured with the six-minute walking test (6MWT). Patients will be instructed to walk back and forth along a 20m hallway, and the distance covered in 6 minutes (6MWD) will be recorded (meters).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Adherence to the exercise intervention</measure>
      <time_frame>from date of baseline assessment until date of surgery,an average of 4 weeks, recorded in steps</time_frame>
      <description>Adherence will be monitored by use of logbooks and a smart watch (FitBit), which records daily steps.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adherence to the nutrition intervention</measure>
      <time_frame>from date of baseline assessment until date of surgery, an average of 4 weeks, recorded in % of prescription adherence</time_frame>
      <description>Adherence to dietary targets (energy intake) will be carefully monitored by weekly in-person or virtual visit using 24hr recalls and supplement counts (energy consumption as compared to prescribed energy targets)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adherence to the nutrition intervention</measure>
      <time_frame>from date of baseline assessment until date of surgery, an average of 4 weeks, recorded in % of prescription adherence</time_frame>
      <description>Adherence to dietary targets (protein intake) will be carefully monitored by weekly in-person or virtual visit using 24hr recalls and supplement counts (protein consumption as compared to prescribed protein targets)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Prehabilitation</condition>
    <condition>Malnutrition</condition>
    <condition>Physical Functional Performance</condition>
    <arm_group>
      <arm_group_label>Nutrition and exercise</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>The nutrition intervention will be based on a comprehensive nutrition assessment by a dietitian at baseline, enabling individualized caloric and protein targets.&#xD;
  The exercise intervention will be personalized based on a comprehensive assessment to include both a resistance and an aerobic component in the form of a &quot;snack&quot;.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Nutrition only</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>The nutrition intervention will be based on a comprehensive nutrition assessment by a dietitian at baseline, enabling individualized caloric and protein targets.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Nutrition</intervention_name>
      <description>The nutrition intervention will be based on needs assessed by indirect calorimetry, patient-generated subjective global assessment, and 24hr recall conducted at baseline, enabling individualized caloric and protein targets.&#xD;
  Deficits in nutrient intake will be addressed with one-on-one dietary counselling and supplementation at baseline in a quantity that matches the estimated deficit in intake. Adherence will be monitored using 24-hr recalls and weight status by the dietitian weekly.</description>
      <arm_group_label>Nutrition and exercise</arm_group_label>
      <arm_group_label>Nutrition only</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Exercise</intervention_name>
      <description>The exercise intervention will include both a resistance and an aerobic component to be performed a total of 5 times a day, 5 times per week, 5 minutes each session, totaling 125 minutes per week. The ability to perform exercises as prescribed will be monitored with a weekly in-person or virtual supervised session.</description>
      <arm_group_label>Nutrition and exercise</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients aged 65 years and older;&#xD;
  &#xD;
            -  Patients with cancer scheduled for primary colorectal resection;&#xD;
  &#xD;
            -  Patients with 6MWD at baseline less than 400 m;&#xD;
  &#xD;
            -  Patients with Patient-Generated Subjective-Global Assessment (malnutrition assessment)&#xD;
               score equal or greater than 9.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with history of premorbid conditions that contraindicate exercise including&#xD;
               dementia, -Parkinson's disease or previous stroke with paresis;&#xD;
  &#xD;
            -  Metastatic cancer;&#xD;
  &#xD;
            -  Patients who do not speak English or French and cannot be accompanied by someone who&#xD;
               speaks English or French;&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Chelsia Gillis, RD PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>McGill University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Chelsia Gillis, RD PhD</last_name>
      <phone>514-398-7905</phone>
      <email>chelsia.gillis@mcgill.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Natalia Tomborelli Bellafronte, RD PhD</last_name>
      <email>natbella@ymail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>MUHC Research Ethics Board</name>
        <address>
          <city>Montréal</city>
          <state>Quebec</state>
          <zip>H4A 3T2</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Elizabeth Craven, PhD</last_name>
        <phone>514 934-1934</phone>
        <phone_ext>22319</phone_ext>
        <email>reb.ct1@muhc.mcgill.ca</email>
      </contact>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <reference>
      <citation>Gillis C, Fenton TR, Gramlich L, Keller H, Sajobi TT, Culos-Reed SN, Richer L, Awasthi R, Carli F. Malnutrition modifies the response to multimodal prehabilitation: a pooled analysis of prehabilitation trials. Appl Physiol Nutr Metab. 2022 Feb;47(2):141-150. doi: 10.1139/apnm-2021-0299. Epub 2021 Sep 29.</citation>
      <PMID>34587460</PMID>
    </reference>
    <reference>
      <citation>Carli F, Bousquet-Dion G, Awasthi R, Elsherbini N, Liberman S, Boutros M, Stein B, Charlebois P, Ghitulescu G, Morin N, Jagoe T, Scheede-Bergdahl C, Minnella EM, Fiore JF Jr. Effect of Multimodal Prehabilitation vs Postoperative Rehabilitation on 30-Day Postoperative Complications for Frail Patients Undergoing Resection of Colorectal Cancer: A Randomized Clinical Trial. JAMA Surg. 2020 Mar 1;155(3):233-242. doi: 10.1001/jamasurg.2019.5474. Erratum In: JAMA Surg. 2020 Mar 1;155(3):269.</citation>
      <PMID>31968063</PMID>
    </reference>
    <reference>
      <citation>Gillis C, Buhler K, Bresee L, Carli F, Gramlich L, Culos-Reed N, Sajobi TT, Fenton TR. Effects of Nutritional Prehabilitation, With and Without Exercise, on Outcomes of Patients Who Undergo Colorectal Surgery: A Systematic Review and Meta-analysis. Gastroenterology. 2018 Aug;155(2):391-410.e4. doi: 10.1053/j.gastro.2018.05.012. Epub 2018 May 8.</citation>
      <PMID>29750973</PMID>
    </reference>
    <reference>
      <citation>Weimann A, Braga M, Carli F, Higashiguchi T, Hubner M, Klek S, Laviano A, Ljungqvist O, Lobo DN, Martindale R, Waitzberg DL, Bischoff SC, Singer P. ESPEN guideline: Clinical nutrition in surgery. Clin Nutr. 2017 Jun;36(3):623-650. doi: 10.1016/j.clnu.2017.02.013. Epub 2017 Mar 7.</citation>
      <PMID>28385477</PMID>
    </reference>
    <reference>
      <citation>Gillis C, Fenton TR, Gramlich L, Sajobi TT, Culos-Reed SN, Bousquet-Dion G, Elsherbini N, Fiore JF Jr, Minnella EM, Awasthi R, Liberman AS, Boutros M, Carli F. Older frail prehabilitated patients who cannot attain a 400 m 6-min walking distance before colorectal surgery suffer more postoperative complications. Eur J Surg Oncol. 2021 Apr;47(4):874-881. doi: 10.1016/j.ejso.2020.09.041. Epub 2020 Oct 5.</citation>
      <PMID>33041092</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>McGill University</investigator_affiliation>
      <investigator_full_name>Chelsia Ann Gillis</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Malnutrition</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05999370
  org study id: 37-2021-6990
  nct id: NCT05999370
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Despite multi-modal prehabilitation (nutrition, exercise, and psychosocial interventions),
        60% of older elective colorectal cancer surgery patients with poor physical function were
        unable to reach a minimum preoperative 400m six-minute walking distance (6MWD), a prognostic
        cut-point. Compared to the patients that attained >400m 6MWD preoperatively, twice as many of
        <400m patients were malnourished. Malnutrition has long been associated with worse
        functioning (e.g., physical, immune). The investigators hypothesize that for nutritionally
        deficient patients, the etiology for their poor physical function is malnutrition. Correction
        of malnutrition alone might thus be sufficient to achieve a 400m 6MWD before surgery and
        improve patient outcomes.
  The investigators propose a randomized controlled trial of nutrition prehabilitation alone vs
        nutrition prehabilitation with supportive exercise in patients with malnutrition and 6MWD
        <400m before elective colorectal surgery. The primary objective, and therapeutic target, will
        be achievement of minimal clinical important difference for the 6MWD (14m for within group
        comparisons and 19m between groups). Ability to adhere to the interventions will be
        monitored. The findings of this study will guide optimal treatment for this vulnerable
        population by exploring the role of nutrition alone vs. nutrition with exercise to optimize
        surgical outcomes.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Preoperative six-minute walking distance
  time frame: from date of baseline assessment until date of surgery, an average of 4 weeks, recorded in meters
  description: Physical function will be measured with the six-minute walking test (6MWT). Patients will be instructed to walk back and forth along a 20m hallway, and the distance covered in 6 minutes (6MWD) will be recorded (meters).
  measure: Adherence to the exercise intervention
  time frame: from date of baseline assessment until date of surgery,an average of 4 weeks, recorded in steps
  description: Adherence will be monitored by use of logbooks and a smart watch (FitBit), which records daily steps.
  measure: Adherence to the nutrition intervention
  time frame: from date of baseline assessment until date of surgery, an average of 4 weeks, recorded in % of prescription adherence
  description: Adherence to dietary targets (energy intake) will be carefully monitored by weekly in-person or virtual visit using 24hr recalls and supplement counts (energy consumption as compared to prescribed energy targets)
  measure: Adherence to the nutrition intervention
  time frame: from date of baseline assessment until date of surgery, an average of 4 weeks, recorded in % of prescription adherence
  description: Adherence to dietary targets (protein intake) will be carefully monitored by weekly in-person or virtual visit using 24hr recalls and supplement counts (protein consumption as compared to prescribed protein targets)
  arm group label: Nutrition and exercise
  arm group type: Other
  description: The nutrition intervention will be based on a comprehensive nutrition assessment by a dietitian at baseline, enabling individualized caloric and protein targets.
  The exercise intervention will be personalized based on a comprehensive assessment to include both a resistance and an aerobic component in the form of a "snack".
  arm group label: Nutrition only
  arm group type: Other
  description: The nutrition intervention will be based on a comprehensive nutrition assessment by a dietitian at baseline, enabling individualized caloric and protein targets.
  intervention type: Behavioral
  intervention name: Nutrition
  description: The nutrition intervention will be based on needs assessed by indirect calorimetry, patient-generated subjective global assessment, and 24hr recall conducted at baseline, enabling individualized caloric and protein targets.
  Deficits in nutrient intake will be addressed with one-on-one dietary counselling and supplementation at baseline in a quantity that matches the estimated deficit in intake. Adherence will be monitored using 24-hr recalls and weight status by the dietitian weekly.
  arm group label: Nutrition and exercise
  arm group label: Nutrition only
  intervention type: Behavioral
  intervention name: Exercise
  description: The exercise intervention will include both a resistance and an aerobic component to be performed a total of 5 times a day, 5 times per week, 5 minutes each session, totaling 125 minutes per week. The ability to perform exercises as prescribed will be monitored with a weekly in-person or virtual supervised session.
  arm group label: Nutrition and exercise
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Chelsia Gillis, RD PhD
  role: Principal Investigator
  affiliation: McGill University
  last name: Chelsia Gillis, RD PhD
  phone: 514-398-7905
  email: chelsia.gillis@mcgill.ca
  last name: Natalia Tomborelli Bellafronte, RD PhD
  email: natbella@ymail.com
  facility: 
  status: Recruiting
  contact: 
  country: Canada
  citation: Gillis C, Fenton TR, Gramlich L, Keller H, Sajobi TT, Culos-Reed SN, Richer L, Awasthi R, Carli F. Malnutrition modifies the response to multimodal prehabilitation: a pooled analysis of prehabilitation trials. Appl Physiol Nutr Metab. 2022 Feb;47(2):141-150. doi: 10.1139/apnm-2021-0299. Epub 2021 Sep 29.
  PMID: 34587460
  citation: Carli F, Bousquet-Dion G, Awasthi R, Elsherbini N, Liberman S, Boutros M, Stein B, Charlebois P, Ghitulescu G, Morin N, Jagoe T, Scheede-Bergdahl C, Minnella EM, Fiore JF Jr. Effect of Multimodal Prehabilitation vs Postoperative Rehabilitation on 30-Day Postoperative Complications for Frail Patients Undergoing Resection of Colorectal Cancer: A Randomized Clinical Trial. JAMA Surg. 2020 Mar 1;155(3):233-242. doi: 10.1001/jamasurg.2019.5474. Erratum In: JAMA Surg. 2020 Mar 1;155(3):269.
  PMID: 31968063
  citation: Gillis C, Buhler K, Bresee L, Carli F, Gramlich L, Culos-Reed N, Sajobi TT, Fenton TR. Effects of Nutritional Prehabilitation, With and Without Exercise, on Outcomes of Patients Who Undergo Colorectal Surgery: A Systematic Review and Meta-analysis. Gastroenterology. 2018 Aug;155(2):391-410.e4. doi: 10.1053/j.gastro.2018.05.012. Epub 2018 May 8.
  PMID: 29750973
  citation: Weimann A, Braga M, Carli F, Higashiguchi T, Hubner M, Klek S, Laviano A, Ljungqvist O, Lobo DN, Martindale R, Waitzberg DL, Bischoff SC, Singer P. ESPEN guideline: Clinical nutrition in surgery. Clin Nutr. 2017 Jun;36(3):623-650. doi: 10.1016/j.clnu.2017.02.013. Epub 2017 Mar 7.
  PMID: 28385477
  citation: Gillis C, Fenton TR, Gramlich L, Sajobi TT, Culos-Reed SN, Bousquet-Dion G, Elsherbini N, Fiore JF Jr, Minnella EM, Awasthi R, Liberman AS, Boutros M, Carli F. Older frail prehabilitated patients who cannot attain a 400 m 6-min walking distance before colorectal surgery suffer more postoperative complications. Eur J Surg Oncol. 2021 Apr;47(4):874-881. doi: 10.1016/j.ejso.2020.09.041. Epub 2020 Oct 5.
  PMID: 33041092
  responsible party type: Principal Investigator
  investigator affiliation: McGill University
  investigator full name: Chelsia Ann Gillis
  investigator title: Assistant Professor
  mesh term: Malnutrition
  sharing ipd: No