<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/NCT03256201</url>
  </required_header>
  <id_info>
    <org_study_id>5991</org_study_id>
    <nct_id>NCT03256201</nct_id>
  </id_info>
  <brief_title>Exercise and Nutrition to Improve Pancreatic Cancer Outcomes</brief_title>
  <official_title>Preoperative Exercise and Nutrition to Improve Pancreatic Cancer Outcomes by Targeting Sarcopenia: A Translational Pilot RCT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oklahoma</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Oklahoma</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a blinded pilot study in which patients scheduled for pancreaticoduodenectomy for&#xD;
      pancreatic or related cancers are randomized to dietary counseling and home exercise at high&#xD;
      weekly frequency, either with or without individualized resistance training, in order to&#xD;
      determine if such an intervention and research design are feasible in this population. We&#xD;
      also aim to determine if physical function or quality of life can be improved with only 2-3&#xD;
      weeks of prehabilitation. This is in preparation for a larger study to determine if&#xD;
      resistance improves outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This initial feasibility and proof of concept study focuses on maximizing pancreatic cancer&#xD;
      survivors' fitness and physical function in a brief period, the 2-3 weeks available prior to&#xD;
      surgical resection, using a home-based exercise program with all equipment provided, and&#xD;
      following nutritional recommendations. Intervention begins when the oncologist determines&#xD;
      that the patient is a candidate for pancreaticoduodenectomy, and continues until surgery.&#xD;
      Participants in both arms are asked to perform moderate exercise daily, targeting a total of&#xD;
      60 minutes per day by the surgery date, but in bouts as short as a few minutes each, and&#xD;
      progressed according to tolerance. Initial prescription is individualized according to the&#xD;
      patient's baseline level of exercise and functional status. Patients record their exercise&#xD;
      and wear an accelerometer to track activity if willing. All participants receive follow-up&#xD;
      phone calls from an exercise specialist for adherence and assistance with progression. The&#xD;
      intervention period ends at the time of surgery.&#xD;
&#xD;
      In this 'quasi-double blinded' randomized trial, participants are not told the difference&#xD;
      between the two exercise interventions, and randomization to the two treatment arms is&#xD;
      stratified by baseline functional status, such that patients deemed to be 'borderline' in&#xD;
      fitness for surgery are distributed across the groups. Prior chemotherapy exposure is allowed&#xD;
      and recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 1, 2016</start_date>
  <completion_date type="Anticipated">August 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">April 2024</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Accrual</measure>
    <time_frame>2 year</time_frame>
    <description>The percentage of eligible patients enrolled</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Retention</measure>
    <time_frame>2 year</time_frame>
    <description>Retention as the percentage of enrolled patients retained assessment point</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence</measure>
    <time_frame>2 year</time_frame>
    <description>Adherence will be estimated as percentage of prescribed exercise completed based on exercise diaries and phone calls</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Assessment</measure>
    <time_frame>Approximately 1-3 days pre-op</time_frame>
    <description>Quality of life will be assessed using Functional Assessment of Cancer Therapy General Scale (FACT-G) during the pre-operative period (V1-V2). Scale is 0-108. The higher the score, the better the score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body Weight</measure>
    <time_frame>Approximately 1-3 days pre-op</time_frame>
    <description>Change in baseline body weight in pounds during the pre-operative period (V1-V2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body Weight</measure>
    <time_frame>Approximately 1-3 days pre-op</time_frame>
    <description>Change in baseline body weight in pounds at second post operative visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Performance</measure>
    <time_frame>Approximately 1-3 days pre-op</time_frame>
    <description>Six-Minute Walk Test in meters during the pre-operative period (V1-V2). The Six Minute Walk test will be performed according to American Thoracic Society Guidelines.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Performance</measure>
    <time_frame>Approximately 2-4 weeks pre-op</time_frame>
    <description>Gait Speed at usual pace</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Performance</measure>
    <time_frame>Approximately 1-3 days pre-op</time_frame>
    <description>Grip Strength . with a Jamar handgrip dynamometer .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Performance</measure>
    <time_frame>Approximately 4 months post-op</time_frame>
    <description>Sit-to-Stand .Time to 5th Stand will be performed according to the Short Performance Physical Battery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Symptoms</measure>
    <time_frame>Approximately 4 weeks post-op</time_frame>
    <description>Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep), at first post-operative visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Symptoms</measure>
    <time_frame>Approximately 1-3 days pre-op</time_frame>
    <description>Functional Assessment of Anorexia-Cachexia Therapy - FAACT, during the pre-operative period (V1-V2).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>Standard Exercise Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive a single instruction session with a physical therapist, for training in moderate intensity (using Rate of Perceived Exertion) exercise including cardiovascular endurance, flexibility, and AROM of upper and lower body. If no other preferred mode of endurance training, a home ergometer is provided for use with arms and/or legs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced Exercise Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive a single instruction session with a physical therapist, for training in moderate intensity (using Rate of Perceived Exertion) exercise including cardiovascular endurance, flexibility, and resistance exercise for upper and lower body. If no other preferred mode of endurance training, a home ergometer is provided for use with arms and/or legs.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nutritional Counseling</intervention_name>
    <description>Patients in both arms receive a single counseling session with a licensed dietician to determine individual protein goal for body weight and current dietary intake. Goal is then met through protein supplementation (provided) if needed beyond dietary intake.</description>
    <arm_group_label>Enhanced Exercise Group</arm_group_label>
    <arm_group_label>Standard Exercise Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard Exercise</intervention_name>
    <description>Patients receive a single instruction session with a physical therapist, for training in moderate intensity (using Rate of Perceived Exertion) exercise including cardiovascular endurance, flexibility, and AROM of upper and lower body. If no other preferred mode of endurance training, a home ergometer is provided for use with arms and/or legs.</description>
    <arm_group_label>Standard Exercise Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Enhanced Exercise</intervention_name>
    <description>Patients receive a single instruction session with a physical therapist, for training in moderate intensity (using Rate of Perceived Exertion) exercise including cardiovascular endurance, flexibility, and resistance exercise for upper and lower body. If no other preferred mode of endurance training, a home ergometer is provided for use with arms and/or legs.</description>
    <arm_group_label>Enhanced Exercise Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion:&#xD;
&#xD;
          -  Individuals with suspected pancreatic or related tumor for surgical resection by&#xD;
             pancreaticoduodenectomy, including those who've received neoadjuvant chemotherapy, are&#xD;
             eligible provided they are approved for exercise participation by pancreatic clinic&#xD;
             team.&#xD;
&#xD;
          -  Cognition and English language skills must be sufficient for completion of consent and&#xD;
             questionnaires.&#xD;
&#xD;
          -  Age &gt;30.&#xD;
&#xD;
          -  Able to rise from a chair and walk household distances without assist from another&#xD;
             person.&#xD;
&#xD;
          -  Willing to be randomized to one of two pre-operative home-based exercise programs,&#xD;
             without knowing the difference between the two, and use protein supplementation if&#xD;
             instructed.&#xD;
&#xD;
        Exclusion:&#xD;
&#xD;
          -  Individuals are excluded if they are unsafe (according to the study team) based on&#xD;
             current MD recommendation not to exercise, medical history, recent fracture or&#xD;
             high-risk bone lesion, or neurologic disorder with safety concerns.&#xD;
&#xD;
          -  Participants cannot have an allergy to whey protein, or abnormal response to baseline&#xD;
             physical performance tests of walking endurance and strength.&#xD;
&#xD;
          -  Those who currently participate in a regular and substantial (as defined by the study&#xD;
             team) strengthening or protein supplementation program are eligible only for the 'for&#xD;
             assessment only' observational version of the study, but will not be included in the&#xD;
             randomized trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elizabeth Hile, PhD, PT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculty</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Abby Cha, BS</last_name>
    <phone>405 271-1529</phone>
    <email>abby-cha@ouhsc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rachel Neuhold, PT</last_name>
    <phone>405-271-7635</phone>
    <email>rachel.neuhold@ouhealth.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Oklahoma Health Sciences Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Abby Cha, BS</last_name>
      <phone>405-271-1529</phone>
      <email>abby-cha@ouhsc.edu</email>
    </contact>
    <contact_backup>
      <last_name>Elizabeth Hile, PhD, PT</last_name>
      <phone>405-271-2273</phone>
      <email>Elizabeth-Hile@ouhsc.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>May 26, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>May 15, 2023</last_update_submitted>
  <last_update_submitted_qc>May 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cancer</keyword>
  <keyword>prehabilitation</keyword>
  <keyword>sarcopenia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic 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/NCT03256201
org study id: 5991
nct id: NCT03256201
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a blinded pilot study in which patients scheduled for pancreaticoduodenectomy for
      pancreatic or related cancers are randomized to dietary counseling and home exercise at high
      weekly frequency, either with or without individualized resistance training, in order to
      determine if such an intervention and research design are feasible in this population. We
      also aim to determine if physical function or quality of life can be improved with only 2-3
      weeks of prehabilitation. This is in preparation for a larger study to determine if
      resistance improves outcomes.
This initial feasibility and proof of concept study focuses on maximizing pancreatic cancer
      survivors' fitness and physical function in a brief period, the 2-3 weeks available prior to
      surgical resection, using a home-based exercise program with all equipment provided, and
      following nutritional recommendations. Intervention begins when the oncologist determines
      that the patient is a candidate for pancreaticoduodenectomy, and continues until surgery.
      Participants in both arms are asked to perform moderate exercise daily, targeting a total of
      60 minutes per day by the surgery date, but in bouts as short as a few minutes each, and
      progressed according to tolerance. Initial prescription is individualized according to the
      patient's baseline level of exercise and functional status. Patients record their exercise
      and wear an accelerometer to track activity if willing. All participants receive follow-up
      phone calls from an exercise specialist for adherence and assistance with progression. The
      intervention period ends at the time of surgery.

      In this 'quasi-double blinded' randomized trial, participants are not told the difference
      between the two exercise interventions, and randomization to the two treatment arms is
      stratified by baseline functional status, such that patients deemed to be 'borderline' in
      fitness for surgery are distributed across the groups. Prior chemotherapy exposure is allowed
      and recorded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Accrual
time frame: 2 year
description: The percentage of eligible patients enrolled
measure: Retention
time frame: 2 year
description: Retention as the percentage of enrolled patients retained assessment point
measure: Adherence
time frame: 2 year
description: Adherence will be estimated as percentage of prescribed exercise completed based on exercise diaries and phone calls
measure: Quality of Life Assessment
time frame: Approximately 1-3 days pre-op
description: Quality of life will be assessed using Functional Assessment of Cancer Therapy General Scale (FACT-G) during the pre-operative period (V1-V2). Scale is 0-108. The higher the score, the better the score.
measure: Change in Body Weight
time frame: Approximately 1-3 days pre-op
description: Change in baseline body weight in pounds during the pre-operative period (V1-V2)
measure: Change in Body Weight
time frame: Approximately 1-3 days pre-op
description: Change in baseline body weight in pounds at second post operative visit
measure: Physical Performance
time frame: Approximately 1-3 days pre-op
description: Six-Minute Walk Test in meters during the pre-operative period (V1-V2). The Six Minute Walk test will be performed according to American Thoracic Society Guidelines.
measure: Physical Performance
time frame: Approximately 2-4 weeks pre-op
description: Gait Speed at usual pace
measure: Physical Performance
time frame: Approximately 1-3 days pre-op
description: Grip Strength . with a Jamar handgrip dynamometer .
measure: Physical Performance
time frame: Approximately 4 months post-op
description: Sit-to-Stand .Time to 5th Stand will be performed according to the Short Performance Physical Battery.
measure: Assessment of Symptoms
time frame: Approximately 4 weeks post-op
description: Functional Assessment of Cancer Therapy - Hepatobiliary (FACT-Hep), at first post-operative visit.
measure: Assessment of Symptoms
time frame: Approximately 1-3 days pre-op
description: Functional Assessment of Anorexia-Cachexia Therapy - FAACT, during the pre-operative period (V1-V2).
arm group label: Standard Exercise Group
arm group type: Experimental
description: Patients receive a single instruction session with a physical therapist, for training in moderate intensity (using Rate of Perceived Exertion) exercise including cardiovascular endurance, flexibility, and AROM of upper and lower body. If no other preferred mode of endurance training, a home ergometer is provided for use with arms and/or legs.
arm group label: Enhanced Exercise Group
arm group type: Experimental
description: Patients receive a single instruction session with a physical therapist, for training in moderate intensity (using Rate of Perceived Exertion) exercise including cardiovascular endurance, flexibility, and resistance exercise for upper and lower body. If no other preferred mode of endurance training, a home ergometer is provided for use with arms and/or legs.
intervention type: Behavioral
intervention name: Nutritional Counseling
description: Patients in both arms receive a single counseling session with a licensed dietician to determine individual protein goal for body weight and current dietary intake. Goal is then met through protein supplementation (provided) if needed beyond dietary intake.
arm group label: Enhanced Exercise Group
arm group label: Standard Exercise Group
intervention type: Behavioral
intervention name: Standard Exercise
description: Patients receive a single instruction session with a physical therapist, for training in moderate intensity (using Rate of Perceived Exertion) exercise including cardiovascular endurance, flexibility, and AROM of upper and lower body. If no other preferred mode of endurance training, a home ergometer is provided for use with arms and/or legs.
arm group label: Standard Exercise Group
intervention type: Behavioral
intervention name: Enhanced Exercise
description: Patients receive a single instruction session with a physical therapist, for training in moderate intensity (using Rate of Perceived Exertion) exercise including cardiovascular endurance, flexibility, and resistance exercise for upper and lower body. If no other preferred mode of endurance training, a home ergometer is provided for use with arms and/or legs.
arm group label: Enhanced Exercise Group
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: No
last name: Elizabeth Hile, PhD, PT
role: Principal Investigator
affiliation: Faculty
last name: Abby Cha, BS
phone: 405 271-1529
email: abby-cha@ouhsc.edu
last name: Rachel Neuhold, PT
phone: 405-271-7635
email: rachel.neuhold@ouhealth.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms
sharing ipd: No