<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/NCT03021174</url>
  </required_header>
  <id_info>
    <org_study_id>RSRB00066046</org_study_id>
    <nct_id>NCT03021174</nct_id>
  </id_info>
  <brief_title>Exercise and Nutrition Interventions During Chemotherapy</brief_title>
  <official_title>A Feasibility Pilot Study on the Effects of Exercise on Chemotherapy-induced Peripheral Neuropathy and Interoceptive Brain Circuitry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Rochester</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 feasibility pilot study to initiate a research program to assess the effects of&#xD;
      exercise on chemotherapy-induced peripheral neuropathy (numbness, tingling, and pain in the&#xD;
      hands and feet).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a feasibility pilot study to help obtain external funding for a larger study to&#xD;
      assess the effects of exercise on chemotherapy-induced peripheral neuropathy (CIPN), which is&#xD;
      a dose-limiting and painful side effect of chemotherapy for which there are no established&#xD;
      treatments. The investigators will conduct a two-arm randomized clinical trial in 40 cancer&#xD;
      patients receiving chemotherapy where Arm 1 is 12 weeks of exercise during chemotherapy and&#xD;
      Arm 2 is 12 weeks of nutrition education (control condition) during chemotherapy. The&#xD;
      investigators will acquire data on CIPN via patient reports and clinical assessments as well&#xD;
      as general pain and hypothetical mechanistic factors that may help explain how exercise may&#xD;
      treat CIPN; these factors include measures of musculoskeletal, cardiovascular,&#xD;
      neuropsychological, and immunological function. The primary outcomes are related to the&#xD;
      feasibility of identifying, recruiting, and obtaining complete data from research&#xD;
      participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 28, 2017</start_date>
  <completion_date type="Actual">October 11, 2018</completion_date>
  <primary_completion_date type="Actual">October 11, 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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent of patients screened who are eligible</measure>
    <time_frame>12 weeks</time_frame>
    <description>Number of patients eligible divided by number of patients screened</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of patients eligible who are consented</measure>
    <time_frame>12 weeks</time_frame>
    <description>Number of patients consented divided by number of patients approached</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of patients consented who complete the exercise intervention</measure>
    <time_frame>12 weeks</time_frame>
    <description>Number of patients in exercise arm who improve daily steps divided by number of patients in exercise arm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of patients consented who complete pre- and post-intervention measures of the patient-reported assessment of chemotherapy-induced peripheral neuropathy</measure>
    <time_frame>12 weeks</time_frame>
    <description>Number of patients who completed pre- and post-intervention CIPN-20 questionnaire divided by number of patients consented (both arms)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Neuropathy;Peripheral</condition>
  <arm_group>
    <arm_group_label>Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exercise for Cancer Patients (EXCAP©®), developed by Dr. Karen Mustian, involves face-to-face instruction and a prescription for an at-home progressive walking and resistance exercise program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nutrition Education Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nutrition education (control) involves equal time and attention as the exercise arm, but the content covers nutrition for cancer patients and lacks an exercise prescription.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>EXCAP Exercise</intervention_name>
    <description>12 weeks of at-home walking and resistance exercise</description>
    <arm_group_label>Exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nutrition Education Control</intervention_name>
    <description>12 weeks of implementing eating tips</description>
    <arm_group_label>Nutrition Education Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have non-metastatic cancer&#xD;
&#xD;
          -  Be chemotherapy naïve&#xD;
&#xD;
          -  Be scheduled to receive CIPN-inducing chemotherapy during the study (platinums, vinca&#xD;
             alkaloids, taxanes, thalidomide, or bortezomib) for the duration of the intervention&#xD;
             (12 weeks)&#xD;
&#xD;
          -  Report symptoms of peripheral neuropathy at baseline (subject-reported severity of&#xD;
             numbness and tingling in hands/feet of at least 1 on a 0-10 scale)&#xD;
&#xD;
          -  Be able to perform the exercise intervention&#xD;
&#xD;
          -  Be able to read English&#xD;
&#xD;
          -  Be at least 18 years old (no upper limit on age)&#xD;
&#xD;
          -  Be consistently right-handed in daily activities for consistency in reporting any&#xD;
             lateralized effects from brain imaging&#xD;
&#xD;
          -  Provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Receive surgery, radiation, or hormone therapy for their cancer during the study&#xD;
&#xD;
          -  Be in the active or maintenance stage of exercise behavior (i.e., subjects must be&#xD;
             sedentary)&#xD;
&#xD;
          -  Have contraindications for MRI scanning (pacemaker, metal implants, pregnancy, etc. -&#xD;
             note that most port-a-caths are safe for MRI scanning)&#xD;
&#xD;
          -  Have physical limitations (e.g., cardiorespiratory, orthopedic, central nervous&#xD;
             system) that contraindicate participation in maximal physiological fitness testing and&#xD;
             a low/moderate intensity home-based walking and progressive resistance exercise&#xD;
             program.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Rochester Medical Center</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>July 16, 2019</last_update_submitted>
  <last_update_submitted_qc>July 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Rochester</investigator_affiliation>
    <investigator_full_name>Ian Kleckner</investigator_full_name>
    <investigator_title>Research Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>CIPN</keyword>
  <keyword>Chemotherapy-induced peripheral neuropathy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Nervous System Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Interested researchers may contact the study PI with requests for collaboration.</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/NCT03021174
org study id: RSRB00066046
nct id: NCT03021174
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a feasibility pilot study to initiate a research program to assess the effects of
      exercise on chemotherapy-induced peripheral neuropathy (numbness, tingling, and pain in the
      hands and feet).
This is a feasibility pilot study to help obtain external funding for a larger study to
      assess the effects of exercise on chemotherapy-induced peripheral neuropathy (CIPN), which is
      a dose-limiting and painful side effect of chemotherapy for which there are no established
      treatments. The investigators will conduct a two-arm randomized clinical trial in 40 cancer
      patients receiving chemotherapy where Arm 1 is 12 weeks of exercise during chemotherapy and
      Arm 2 is 12 weeks of nutrition education (control condition) during chemotherapy. The
      investigators will acquire data on CIPN via patient reports and clinical assessments as well
      as general pain and hypothetical mechanistic factors that may help explain how exercise may
      treat CIPN; these factors include measures of musculoskeletal, cardiovascular,
      neuropsychological, and immunological function. The primary outcomes are related to the
      feasibility of identifying, recruiting, and obtaining complete data from research
      participants.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Percent of patients screened who are eligible
time frame: 12 weeks
description: Number of patients eligible divided by number of patients screened
measure: Percent of patients eligible who are consented
time frame: 12 weeks
description: Number of patients consented divided by number of patients approached
measure: Percent of patients consented who complete the exercise intervention
time frame: 12 weeks
description: Number of patients in exercise arm who improve daily steps divided by number of patients in exercise arm
measure: Percent of patients consented who complete pre- and post-intervention measures of the patient-reported assessment of chemotherapy-induced peripheral neuropathy
time frame: 12 weeks
description: Number of patients who completed pre- and post-intervention CIPN-20 questionnaire divided by number of patients consented (both arms)
arm group label: Exercise
arm group type: Experimental
description: Exercise for Cancer Patients (EXCAP©®), developed by Dr. Karen Mustian, involves face-to-face instruction and a prescription for an at-home progressive walking and resistance exercise program.
arm group label: Nutrition Education Control
arm group type: Active Comparator
description: Nutrition education (control) involves equal time and attention as the exercise arm, but the content covers nutrition for cancer patients and lacks an exercise prescription.
intervention type: Behavioral
intervention name: EXCAP Exercise
description: 12 weeks of at-home walking and resistance exercise
arm group label: Exercise
intervention type: Behavioral
intervention name: Nutrition Education Control
description: 12 weeks of implementing eating tips
arm group label: Nutrition Education Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Rochester
investigator full name: Ian Kleckner
investigator title: Research Assistant Professor
mesh term: Peripheral Nervous System Diseases
sharing ipd: No
ipd description: Interested researchers may contact the study PI with requests for collaboration.