<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/NCT03244683</url>
  </required_header>
  <id_info>
    <org_study_id>2017H0170</org_study_id>
    <nct_id>NCT03244683</nct_id>
  </id_info>
  <brief_title>A Study of the Efficacy of ONS to Reduce Postoperative Complications Associated With Pancreatic Surgery</brief_title>
  <acronym>INSPIRE</acronym>
  <official_title>A Study of the Efficacy of Oral Nutritional Supplementation to Reduce Postoperative Complications Associated With Pancreatic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Abbott Nutrition</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Ohio State University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single center, open label, randomized trial, involving 150 patients undergoing&#xD;
      pancreatic surgery. Patients will be randomized at the time of enrollment to receive from 5-7&#xD;
      days of ONS supplementation combined with resistance training and nutritional education&#xD;
      compared to standard of care, consisting of nutritional education alone.&#xD;
&#xD;
      This proof of concept study is intended to demonstrate the ability of pre-habilitation to&#xD;
      improve patient-related outcomes following pancreatic surgery, specifically postoperative&#xD;
      complications. The rationale for using the designated oral nutrient supplementation is to&#xD;
      preserve muscle mass, and decrease weight loss.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients undergoing pancreatic surgery for either chronic pancreatitis or known/suspected&#xD;
      pancreatic cancer represent the study population for this clinical trial.&#xD;
&#xD;
      Study subjects randomized to one of the ONS arms will be asked to consume the drink during&#xD;
      the study intervention. Study visits immediately preoperative, and 1, 3, and 6 months&#xD;
      following surgery will be in-person visits. If subjects are unable to return to our&#xD;
      Institution for subsequent clinical care, these telephone interviews will be collected and&#xD;
      acquisition of locally obtained laboratory tests will be attempted.&#xD;
&#xD;
      Assessments performed during postoperative visits include:&#xD;
&#xD;
        -  Vital signs and physical examination&#xD;
&#xD;
        -  Blood samples&#xD;
&#xD;
        -  Performance status and strength&#xD;
&#xD;
        -  Quality of life measures&#xD;
&#xD;
        -  Postoperative complications and hospital readmissions (if any)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Closed due to low enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">August 28, 2017</start_date>
  <completion_date type="Actual">August 1, 2018</completion_date>
  <primary_completion_date type="Actual">August 1, 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative complications</measure>
    <time_frame>30 days</time_frame>
    <description>The postoperative complication rate of 1 or more complication</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Supplement compliance</measure>
    <time_frame>7-14 days</time_frame>
    <description>Frequency of subjects compliant with ≥70% of the provided preoperative supplement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anthropometric measures</measure>
    <time_frame>30 days</time_frame>
    <description>Serial anthropometric measures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay and readmission</measure>
    <time_frame>30 days</time_frame>
    <description>Hospital length of stay and readmission rate</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Pancreatic Cancer</condition>
  <condition>Chronic Pancreatitis</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects randomized to this arm will receive: An Oral Nutritional Supplementation (Ensure Surgical), home-based resistance training, and dietary counseling</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nutrition Counseling alone</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects randomized to this arm will receive: Dietary counseling along with standard of care procedures.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Ensure Surgical</intervention_name>
    <description>Subjects randomized to the intervention arm will consume two Ensure Surgical for 5-7 days.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nutrition counseling</intervention_name>
    <description>All study subjects will be provided with nutrition counseling at the time of study enrollment.</description>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_label>Nutrition Counseling alone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low-intensity exercise therapy</intervention_name>
    <description>Patients randomized to the intervention arm will also be provided with verbal and written instructions for light resistance training. The exercises will be performed at home during the preoperative study period.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 40-89 at the time of study enrollment.&#xD;
&#xD;
          2. Undergoing pancreatectomy for either chronic pancreatitis or pancreatic cancer.&#xD;
&#xD;
          3. Ability and willingness to complete study related documents and activities.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe malnutrition that in the judgment of the patient's supervising physician or an&#xD;
             investigator would not permit surgical intervention without preoperative nutritional&#xD;
             support (enteral or parenteral).&#xD;
&#xD;
          2. Subject is receiving (or planned to receive) enteral tube feeding or parenteral&#xD;
             nutrition at the time of screening or before surgery.&#xD;
&#xD;
          3. Surgery is planned within 7 days of enrollment (i.e., inadequate time to offer the&#xD;
             study intervention).&#xD;
&#xD;
          4. Known allergy to soy or milk, which are included in the oral supplement.&#xD;
&#xD;
          5. The inability to refrain from using a non-study oral nutritional supplement or fish&#xD;
             oil supplementation (unless prescribed for treatment of hyperlipidemia).&#xD;
&#xD;
          6. Pregnancy, incarceration, or inability to provide written informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philip Hart, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Ohio State University Wexner Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Ohio State University Wexner Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>March 2, 2021</last_update_submitted>
  <last_update_submitted_qc>March 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Philip Hart</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>Pancreatitis</mesh_term>
    <mesh_term>Pancreatitis, Chronic</mesh_term>
    <mesh_term>Postoperative Complications</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to share individual participant data to other researchers.</ipd_description>
  </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/NCT03244683
org study id: 2017H0170
nct id: NCT03244683
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This is a single center, open label, randomized trial, involving 150 patients undergoing
      pancreatic surgery. Patients will be randomized at the time of enrollment to receive from 5-7
      days of ONS supplementation combined with resistance training and nutritional education
      compared to standard of care, consisting of nutritional education alone.

      This proof of concept study is intended to demonstrate the ability of pre-habilitation to
      improve patient-related outcomes following pancreatic surgery, specifically postoperative
      complications. The rationale for using the designated oral nutrient supplementation is to
      preserve muscle mass, and decrease weight loss.
Patients undergoing pancreatic surgery for either chronic pancreatitis or known/suspected
      pancreatic cancer represent the study population for this clinical trial.

      Study subjects randomized to one of the ONS arms will be asked to consume the drink during
      the study intervention. Study visits immediately preoperative, and 1, 3, and 6 months
      following surgery will be in-person visits. If subjects are unable to return to our
      Institution for subsequent clinical care, these telephone interviews will be collected and
      acquisition of locally obtained laboratory tests will be attempted.

      Assessments performed during postoperative visits include:

        -  Vital signs and physical examination

        -  Blood samples

        -  Performance status and strength

        -  Quality of life measures

        -  Postoperative complications and hospital readmissions (if any)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Postoperative complications
time frame: 30 days
description: The postoperative complication rate of 1 or more complication
measure: Supplement compliance
time frame: 7-14 days
description: Frequency of subjects compliant with ≥70% of the provided preoperative supplement.
measure: Anthropometric measures
time frame: 30 days
description: Serial anthropometric measures.
measure: Length of stay and readmission
time frame: 30 days
description: Hospital length of stay and readmission rate
arm group label: Intervention
arm group type: Other
description: Subjects randomized to this arm will receive: An Oral Nutritional Supplementation (Ensure Surgical), home-based resistance training, and dietary counseling
arm group label: Nutrition Counseling alone
arm group type: Other
description: Subjects randomized to this arm will receive: Dietary counseling along with standard of care procedures.
intervention type: Dietary Supplement
intervention name: Ensure Surgical
description: Subjects randomized to the intervention arm will consume two Ensure Surgical for 5-7 days.
arm group label: Intervention
intervention type: Other
intervention name: Nutrition counseling
description: All study subjects will be provided with nutrition counseling at the time of study enrollment.
arm group label: Intervention
arm group label: Nutrition Counseling alone
intervention type: Other
intervention name: Low-intensity exercise therapy
description: Patients randomized to the intervention arm will also be provided with verbal and written instructions for light resistance training. The exercises will be performed at home during the preoperative study period.
arm group label: Intervention
criteria: 
gender: All
minimum age: 40 Years
maximum age: 89 Years
healthy volunteers: No
last name: Philip Hart, MD
role: Principal Investigator
affiliation: The Ohio State University Wexner Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Ohio State University
investigator full name: Philip Hart
investigator title: Assistant Professor
mesh term: Pancreatitis
mesh term: Pancreatitis, Chronic
mesh term: Postoperative Complications
sharing ipd: No
ipd description: There is no plan to share individual participant data to other researchers.