<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/NCT04449445</url>
  </required_header>
  <id_info>
    <org_study_id>2018-1147</org_study_id>
    <nct_id>NCT04449445</nct_id>
  </id_info>
  <brief_title>Perioperative Nutritional Optimization in Head and Neck Cancer Patients</brief_title>
  <official_title>Perioperative Nutritional Optimization in Head and Neck Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Illinois at Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Illinois at Chicago</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>
      To determine whether nutritional optimization in head and neck cancer patients undergoing&#xD;
      major surgery will decrease post-operative wound complications. The Investigators hypothesize&#xD;
      that nutritional supplementation with Nestle Impact Advanced Recovery (AR) will decrease the&#xD;
      rate of wound complications after surgery&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to determine whether nutritional optimization in head and neck&#xD;
      cancer patients undergoing major surgery will decrease post-operative wound complications. It&#xD;
      is likely that many head and neck cancer patients suffer from sarcopenia, and this&#xD;
      contributes to many wound complications, including wound infection, dehiscence, fistula&#xD;
      formation, and free flap tissue loss. The Investigators hypothesize that nutritional&#xD;
      supplementation with Nestle Impact Advanced Recovery (AR) will decrease the rate of wound&#xD;
      complications after surgery&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    COVID-19&#xD;
  </why_stopped>
  <start_date type="Anticipated">April 2021</start_date>
  <completion_date type="Anticipated">November 2021</completion_date>
  <primary_completion_date type="Anticipated">October 2021</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assess the effect of perioperative use of Nestle Impact AR</measure>
    <time_frame>30 days post-op</time_frame>
    <description>Assess the rate of post-operative wound infection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assess the effect of perioperative use of Nestle Impact AR</measure>
    <time_frame>30 days</time_frame>
    <description>Assess the rate of post-operative seroma</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assess the effect of perioperative use of Nestle Impact AR</measure>
    <time_frame>30 days post-op</time_frame>
    <description>Assess the rate of post-operative wound dehiscence</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assess the effect of perioperative use of Nestle Impact AR</measure>
    <time_frame>30 days post-op</time_frame>
    <description>Assess the rate of post-operative fistula formation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assess the effect of perioperative use of Nestle Impact AR</measure>
    <time_frame>30 days post-op</time_frame>
    <description>Assess the rate of post-operative free tissue flap loss</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess whether sarcopenia is an independent risk factor for the development of post-operative wound complications</measure>
    <time_frame>30 days post-op</time_frame>
    <description>A small biopsy of the sternocleidomastoid muscle will be taken to evaluate the presence of the key regulatory factors associated with sarcopenia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess whether sarcopenia is an independent risk factor for the development of post-operative wound complications</measure>
    <time_frame>30 days post-op</time_frame>
    <description>Exome sequencing will be performed to assess expression of sarcopenia-related genes in peripheral blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess whether sarcopenia is an independent risk factor for the development of post-operative wound complications</measure>
    <time_frame>30 days post-op</time_frame>
    <description>Measurement of mean muscle mass at L3 on cross-sectional body imaging</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Head and Neck Cancer</condition>
  <arm_group>
    <arm_group_label>Standard enteral tube feeds</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients will be instructed to continue a normal diet before surgery. Post-operatively, patients will receive standard of care isocaloric and iso-nitrogenous standard enteral tube feeds</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nestle IMPACT AR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be encouraged to continue their regular diet until their surgery day. In addition, beginning 5 days before surgery, subjects will be instructed to drink three, 6 ounce cartons of Nestle IMPACT AR each day until their surgery. Post operatively patients who are able to eat orally, will be given three, 6 ounce cartons of Nestle IMPACT AR to drink each day for 5 days. Patients who are not able to tolerate an oral diet will be given Nestle IMPACT via a continuous tube feeding for 5 days through a temporary nasogastric feeding tube placed per standard post-operative care. Dosing of the tube feeding will be based on weight at a rate of approximately 70-75 cc/hour.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Isocaloric and iso-nitrogenous standard enteral tube feeds</intervention_name>
    <description>Dietary supplement</description>
    <arm_group_label>Standard enteral tube feeds</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Nestle IMPACT AR</intervention_name>
    <description>Dietary supplement</description>
    <arm_group_label>Nestle IMPACT AR</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;18 years. Both men and women and members of all races and ethnic groups will be&#xD;
             included.&#xD;
&#xD;
          -  Patients must be diagnosed with cancer of the head and neck and must be surgical&#xD;
             candidates.&#xD;
&#xD;
          -  Patients must be indicated for major head and neck surgery, defined as surgeries with&#xD;
             an anticipated post-surgical hospital stay of 4 or more days. Examples of major&#xD;
             surgeries include, but are not limited to, total laryngectomy, large oral cavity,&#xD;
             oropharyngeal, salivary gland, or soft tissue resections requiring free flap or major&#xD;
             regional flap (e.g. pectoralis major flap), and large skull base procedures requiring&#xD;
             extensive skull base reconstruction.&#xD;
&#xD;
          -  Patients must have cross-sectional body imaging (PET-CT or equivalent) performed&#xD;
             within 4 weeks of study enrollment and available for review.&#xD;
&#xD;
          -  Patient must be willing to receive Nestle IMPACT Advance Recovery for five days prior&#xD;
             to planned surgery as well as for 5 days after surgery.&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document.&#xD;
&#xD;
          -  All adult men and women with cancer of the head and neck undergoing surgery by the&#xD;
             study PI's at UI Health will be considered for participation in this study without&#xD;
             regard to race, gender or socioeconomic status.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with known distant metastases or other malignancies.&#xD;
&#xD;
          -  Patients unable to tolerate oral intake by mouth or per enteral feeding tube.&#xD;
&#xD;
          -  Patients with galactosemia.&#xD;
&#xD;
          -  Patients who have received any investigational medication within 6 weeks of&#xD;
             enrollment, or who are scheduled to receive an investigational drug during the course&#xD;
             of the study.&#xD;
&#xD;
          -  Patients currently taking IMPACT or other immuno-nutrition products&#xD;
             (arginine-containing supplements) will be excluded. Other forms of nutritional&#xD;
             supplementation, such as caloric supplementation, tube feeding, or other dietary&#xD;
             supplements are allowed on study.&#xD;
&#xD;
          -  Patients currently taking anabolic steroids will be excluded. Patients taking&#xD;
             corticosteroids are allowed on study.&#xD;
&#xD;
          -  Psychiatric illness/social situations that would limit compliance with study&#xD;
             requirements.&#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>Virginie Achim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Illinois at Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Illinois at Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>April 6, 2021</last_update_submitted>
  <last_update_submitted_qc>April 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Illinois at Chicago</investigator_affiliation>
    <investigator_full_name>Virginie Achim</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04449445
org study id: 2018-1147
nct id: NCT04449445
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To determine whether nutritional optimization in head and neck cancer patients undergoing
      major surgery will decrease post-operative wound complications. The Investigators hypothesize
      that nutritional supplementation with Nestle Impact Advanced Recovery (AR) will decrease the
      rate of wound complications after surgery
The purpose of this study is to determine whether nutritional optimization in head and neck
      cancer patients undergoing major surgery will decrease post-operative wound complications. It
      is likely that many head and neck cancer patients suffer from sarcopenia, and this
      contributes to many wound complications, including wound infection, dehiscence, fistula
      formation, and free flap tissue loss. The Investigators hypothesize that nutritional
      supplementation with Nestle Impact Advanced Recovery (AR) will decrease the rate of wound
      complications after surgery
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Assess the effect of perioperative use of Nestle Impact AR
time frame: 30 days post-op
description: Assess the rate of post-operative wound infection
measure: Assess the effect of perioperative use of Nestle Impact AR
time frame: 30 days
description: Assess the rate of post-operative seroma
measure: Assess the effect of perioperative use of Nestle Impact AR
time frame: 30 days post-op
description: Assess the rate of post-operative wound dehiscence
measure: Assess the effect of perioperative use of Nestle Impact AR
time frame: 30 days post-op
description: Assess the rate of post-operative fistula formation
measure: Assess the effect of perioperative use of Nestle Impact AR
time frame: 30 days post-op
description: Assess the rate of post-operative free tissue flap loss
measure: Assess whether sarcopenia is an independent risk factor for the development of post-operative wound complications
time frame: 30 days post-op
description: A small biopsy of the sternocleidomastoid muscle will be taken to evaluate the presence of the key regulatory factors associated with sarcopenia
measure: Assess whether sarcopenia is an independent risk factor for the development of post-operative wound complications
time frame: 30 days post-op
description: Exome sequencing will be performed to assess expression of sarcopenia-related genes in peripheral blood
measure: Assess whether sarcopenia is an independent risk factor for the development of post-operative wound complications
time frame: 30 days post-op
description: Measurement of mean muscle mass at L3 on cross-sectional body imaging
arm group label: Standard enteral tube feeds
arm group type: Other
description: Patients will be instructed to continue a normal diet before surgery. Post-operatively, patients will receive standard of care isocaloric and iso-nitrogenous standard enteral tube feeds
arm group label: Nestle IMPACT AR
arm group type: Experimental
description: Patients will be encouraged to continue their regular diet until their surgery day. In addition, beginning 5 days before surgery, subjects will be instructed to drink three, 6 ounce cartons of Nestle IMPACT AR each day until their surgery. Post operatively patients who are able to eat orally, will be given three, 6 ounce cartons of Nestle IMPACT AR to drink each day for 5 days. Patients who are not able to tolerate an oral diet will be given Nestle IMPACT via a continuous tube feeding for 5 days through a temporary nasogastric feeding tube placed per standard post-operative care. Dosing of the tube feeding will be based on weight at a rate of approximately 70-75 cc/hour.
intervention type: Dietary Supplement
intervention name: Isocaloric and iso-nitrogenous standard enteral tube feeds
description: Dietary supplement
arm group label: Standard enteral tube feeds
intervention type: Dietary Supplement
intervention name: Nestle IMPACT AR
description: Dietary supplement
arm group label: Nestle IMPACT AR
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Virginie Achim, MD
role: Principal Investigator
affiliation: University of Illinois at Chicago
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Illinois at Chicago
investigator full name: Virginie Achim
investigator title: Principal Investigator
mesh term: Head and Neck Neoplasms
sharing ipd: No