<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/NCT03261180</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00015929</org_study_id>
    <secondary_id>NCI-2017-01480</secondary_id>
    <secondary_id>IRB00015929</secondary_id>
    <secondary_id>P30CA069533</secondary_id>
    <nct_id>NCT03261180</nct_id>
  </id_info>
  <brief_title>Nestle Impact Advanced Recovery in Improving Surgery Recovery in Patients With Head and Neck Cancer</brief_title>
  <official_title>Perioperative Nutritional Optimization in Head and Neck Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OHSU Knight Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>OHSU Knight Cancer 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized clinical trial studies how well Nestle Impact Advanced Recovery works in&#xD;
      improving surgery recovery in patients with head and neck cancer. Adding a nutritional&#xD;
      supplement, such as Nestle Impact Advanced Recovery to a regular diet before and after head&#xD;
      and neck cancer surgery may help to decrease the number of wound complications after surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. Assess the effect of perioperative use of Nestle Impact Advanced Recovery (AR) on the rate&#xD;
      of post-operative wound complications within 30 days after major head and neck surgery.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. Assess whether sarcopenia is an independent risk factor for the development of&#xD;
      post-operative wound complications.&#xD;
&#xD;
      II. Assess whether Nestle IMPACT AR decreases the rate of other post-operative complications&#xD;
      such as pneumonia, urinary tract infection, deep vein thrombosis, and clostridium difficile&#xD;
      colitis within 30 days of surgery, as well as length of hospital stay.&#xD;
&#xD;
      TERTIARY OBJECTIVES:&#xD;
&#xD;
      I. Assess changes in muscle metabolic gene expression at the time of surgery associated with&#xD;
      sarcopenia and IMAPCT treatment.&#xD;
&#xD;
      OUTLINE: Patients are randomized into 1 of 2 groups.&#xD;
&#xD;
      GROUP I: Patients receive Nestle Impact AR for 5 days before and after surgery in addition to&#xD;
      regular diet.&#xD;
&#xD;
      GROUP I: Patients receive regular diet.&#xD;
&#xD;
      After completion of study, patients are followed up for 30 days post-surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Insufficient funding&#xD;
  </why_stopped>
  <start_date type="Actual">November 30, 2017</start_date>
  <completion_date type="Anticipated">August 9, 2021</completion_date>
  <primary_completion_date type="Anticipated">August 10, 2020</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>Rate of post-operative wound complications</measure>
    <time_frame>Within 30 days after major head and neck surgery</time_frame>
    <description>A patient is found to have a post-operative complication is one of the following is observed: wound infection, seroma, wound dehiscence, fistula formation, free tissue flap loss. A 2-sided 95% confidence interval will also be calculated for each arm, using exact methods, and chi square testing will be performed to compare the incidence of wound complications within 30 days after surgery between control and experimental groups. A multivariate analysis of the primary endpoint will be performed with logistic regression to include study treatment, presence of sarcopenia, prior radiation therapy, a</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of other post-operative complications</measure>
    <time_frame>Within 30 days after surgery</time_frame>
    <description>Will assess whether Nestle IMPACT Advanced Recovery (AR) decreases the rate of other post-operative complications within 30 days after surgery such as pneumonia, urinary tract infection, deep vein thrombosis, and clostridium difficile colitis as well as length of hospital stay. Will be analyzed using chi square testing. The analysis of the length of the stay (LOS) for patients in each arm will be analyzed using the Kaplan Meier method for estimation of summary statistics including the 25th, 50th (median), and 75th percentiles and associated 95% confidence intervals. Patients that die prior to</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sarcopenia</measure>
    <time_frame>Within 30 days after major head and neck surgery</time_frame>
    <description>Will assess whether sarcopenia is an independent risk factor for the development of 30-day post-operative wound complications. Will be analyzed using chi square testing.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Sarcopenia-related gene expression</measure>
    <time_frame>Up to 30 days post-surgery</time_frame>
    <description>Will asses messenger ribonucleic acid expression level of the sarcopenia-related genes MAFbx, MuRF1, Foxo1, Redd1, Sesn1, SELP, IL-6, BNIP3, and CTSL1, within skeletal muscle, and circulating levels of sarcopenia-associated exomes. Will be analyzed using chi square testing.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Head and Neck Carcinoma</condition>
  <arm_group>
    <arm_group_label>Group I (Nestle Impact AR)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive Nestle Impact AR for 5 days before and after surgery in addition to regular diet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II (regular diet)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receive regular diet.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Best Practice</intervention_name>
    <description>Receive regular diet</description>
    <arm_group_label>Group II (regular diet)</arm_group_label>
    <other_name>standard of care</other_name>
    <other_name>standard therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Biomarker Analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Group I (Nestle Impact AR)</arm_group_label>
    <arm_group_label>Group II (regular diet)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Nutritional Intervention</intervention_name>
    <description>Receive Nestle Impact AR</description>
    <arm_group_label>Group I (Nestle Impact AR)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Members of all races and ethnic groups will be 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 (positron emission tomography&#xD;
             [PET]-computed tomography [CT] or equivalent) performed within 4 weeks of study&#xD;
             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;
        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 immunonutrition 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;
&#xD;
          -  Excluded patients will be allowed to participate in the trial on an observational&#xD;
             basis only&#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>Daniel Clayburgh</last_name>
    <role>Principal Investigator</role>
    <affiliation>OHSU Knight Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>OHSU Knight Cancer Institute</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>February 21, 2020</last_update_submitted>
  <last_update_submitted_qc>February 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>OHSU Knight Cancer Institute</investigator_affiliation>
    <investigator_full_name>Daniel Clayburgh</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>
  <!-- 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/NCT03261180
org study id: STUDY00015929
secondary id: NCI-2017-01480
secondary id: IRB00015929
secondary id: P30CA069533
nct id: NCT03261180
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This randomized clinical trial studies how well Nestle Impact Advanced Recovery works in
      improving surgery recovery in patients with head and neck cancer. Adding a nutritional
      supplement, such as Nestle Impact Advanced Recovery to a regular diet before and after head
      and neck cancer surgery may help to decrease the number of wound complications after surgery.
PRIMARY OBJECTIVES:

      I. Assess the effect of perioperative use of Nestle Impact Advanced Recovery (AR) on the rate
      of post-operative wound complications within 30 days after major head and neck surgery.

      SECONDARY OBJECTIVES:

      I. Assess whether sarcopenia is an independent risk factor for the development of
      post-operative wound complications.

      II. Assess whether Nestle IMPACT AR decreases the rate of other post-operative complications
      such as pneumonia, urinary tract infection, deep vein thrombosis, and clostridium difficile
      colitis within 30 days of surgery, as well as length of hospital stay.

      TERTIARY OBJECTIVES:

      I. Assess changes in muscle metabolic gene expression at the time of surgery associated with
      sarcopenia and IMAPCT treatment.

      OUTLINE: Patients are randomized into 1 of 2 groups.

      GROUP I: Patients receive Nestle Impact AR for 5 days before and after surgery in addition to
      regular diet.

      GROUP I: Patients receive regular diet.

      After completion of study, patients are followed up for 30 days post-surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Rate of post-operative wound complications
time frame: Within 30 days after major head and neck surgery
description: A patient is found to have a post-operative complication is one of the following is observed: wound infection, seroma, wound dehiscence, fistula formation, free tissue flap loss. A 2-sided 95% confidence interval will also be calculated for each arm, using exact methods, and chi square testing will be performed to compare the incidence of wound complications within 30 days after surgery between control and experimental groups. A multivariate analysis of the primary endpoint will be performed with logistic regression to include study treatment, presence of sarcopenia, prior radiation therapy, a
measure: Rate of other post-operative complications
time frame: Within 30 days after surgery
description: Will assess whether Nestle IMPACT Advanced Recovery (AR) decreases the rate of other post-operative complications within 30 days after surgery such as pneumonia, urinary tract infection, deep vein thrombosis, and clostridium difficile colitis as well as length of hospital stay. Will be analyzed using chi square testing. The analysis of the length of the stay (LOS) for patients in each arm will be analyzed using the Kaplan Meier method for estimation of summary statistics including the 25th, 50th (median), and 75th percentiles and associated 95% confidence intervals. Patients that die prior to
measure: Sarcopenia
time frame: Within 30 days after major head and neck surgery
description: Will assess whether sarcopenia is an independent risk factor for the development of 30-day post-operative wound complications. Will be analyzed using chi square testing.
measure: Sarcopenia-related gene expression
time frame: Up to 30 days post-surgery
description: Will asses messenger ribonucleic acid expression level of the sarcopenia-related genes MAFbx, MuRF1, Foxo1, Redd1, Sesn1, SELP, IL-6, BNIP3, and CTSL1, within skeletal muscle, and circulating levels of sarcopenia-associated exomes. Will be analyzed using chi square testing.
arm group label: Group I (Nestle Impact AR)
arm group type: Experimental
description: Patients receive Nestle Impact AR for 5 days before and after surgery in addition to regular diet.
arm group label: Group II (regular diet)
arm group type: Active Comparator
description: Patients receive regular diet.
intervention type: Other
intervention name: Best Practice
description: Receive regular diet
arm group label: Group II (regular diet)
other name: standard of care
other name: standard therapy
intervention type: Other
intervention name: Laboratory Biomarker Analysis
description: Correlative studies
arm group label: Group I (Nestle Impact AR)
arm group label: Group II (regular diet)
intervention type: Dietary Supplement
intervention name: Nutritional Intervention
description: Receive Nestle Impact AR
arm group label: Group I (Nestle Impact AR)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Daniel Clayburgh
role: Principal Investigator
affiliation: OHSU Knight Cancer Institute
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: OHSU Knight Cancer Institute
investigator full name: Daniel Clayburgh
investigator title: Principal Investigator
mesh term: Head and Neck Neoplasms