<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/NCT02991677</url>
  </required_header>
  <id_info>
    <org_study_id>HP-00070946</org_study_id>
    <nct_id>NCT02991677</nct_id>
  </id_info>
  <brief_title>Exercise Effect on Chemotherapy-Induced Neuropathic Pain</brief_title>
  <official_title>Exercise Effect on Chemotherapy-Induced Neuropathic Pain, Peripheral Nerve Fibers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baltimore VA Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baltimore VA Medical Center</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>
      Chemotherapy-induced peripheral neuropathy (CIPN) continues to be a serious healthcare&#xD;
      concern. It is painful, persistent, resistant to conventional pain therapies, and results in&#xD;
      long-term suffering and decreased quality of life for many cancer survivors. The role of&#xD;
      exercise to decrease CIPN-related neuropathic pain (CIPN-NP) will be investigated, with the&#xD;
      goal of identifying the mechanisms associated with this therapeutic approach to manage&#xD;
      CIPN-NP.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Anticipated">March 2022</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sensory pain</measure>
    <time_frame>13 weeks</time_frame>
    <description>Thermal, mechanical, and vibration sensation by quantitative sensory testing</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Nerve fiber density</measure>
    <time_frame>13 weeks</time_frame>
    <description>laboratory examination of skin biopsy samples for measurement of nerve fiber density</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Cancer, Breast</condition>
  <condition>Cancer, Colorectal</condition>
  <condition>Cancer, Lung</condition>
  <condition>Cancer, Ovarian</condition>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This is an attention control group with regular contact by study staff.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>aerobic exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Aerobic exercise intervention is for 12 weeks 3 times weekly with training on site.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>resistive training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention is for 12 weeks 3 times weekly with training on site.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>aerobic exercise intervention</intervention_name>
    <description>Exercise physiologist supervised walking or running on the treadmill 3 times weekly for 12 weeks.</description>
    <arm_group_label>aerobic exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>control group</intervention_name>
    <description>weekly contact by study staff with survivorship information offered not related to neuropathy.</description>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>resistive training</intervention_name>
    <description>Exercise physiologist supervised upper and lower extremity resistive training 3 times weekly for 12 weeks</description>
    <arm_group_label>resistive training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis with cancer, stage I-IV&#xD;
&#xD;
          -  History of treatment with oxaliplatin, docetaxel, or paclitaxel, either alone or in&#xD;
             combination with other agents&#xD;
&#xD;
          -  Completion of chemotherapy &gt; 6 months &lt; 1 year&#xD;
&#xD;
          -  Ability to walk on a treadmill&#xD;
&#xD;
          -  Medical clearance from oncologist or primary care provider&#xD;
&#xD;
          -  Presence of CIPN per National Cancer Institute Common Toxicity Criteria grade 1-3&#xD;
             (0-no signs/symptoms, 1-minor loss of function, 2-increased symptoms not interfering&#xD;
             with activities of daily living (ADLs), 3-severe symptoms interfering with ADL,&#xD;
             4-disabling, and 5 is death)&#xD;
&#xD;
          -  Score on Neuropathic Pain Scale &gt;1&#xD;
&#xD;
          -  Age 21-70&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Denial of CIPN&#xD;
&#xD;
          -  Other motor/sensory neuropathy caused by other than chemotherapy (i.e.alcohol-related,&#xD;
             autoimmune diseases, diabetes)&#xD;
&#xD;
          -  Coronary artery disease&#xD;
&#xD;
          -  History of &gt;1 chemotherapy regimen&#xD;
&#xD;
          -  Musculoskeletal conditions which preclude participation in an exercise training&#xD;
             program&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Regular exerciser, defined as &gt;90 minutes per week of aerobic exercise and any&#xD;
             resistive training&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alice Ryan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Maryland at Baltimore School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Baltimore VA Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>July 19, 2021</last_update_submitted>
  <last_update_submitted_qc>July 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baltimore VA Medical Center</investigator_affiliation>
    <investigator_full_name>Alice S. Ryan, PhD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>exercise</keyword>
  <keyword>neuropathy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Neuralgia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02991677
org study id: HP-00070946
nct id: NCT02991677
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Chemotherapy-induced peripheral neuropathy (CIPN) continues to be a serious healthcare
      concern. It is painful, persistent, resistant to conventional pain therapies, and results in
      long-term suffering and decreased quality of life for many cancer survivors. The role of
      exercise to decrease CIPN-related neuropathic pain (CIPN-NP) will be investigated, with the
      goal of identifying the mechanisms associated with this therapeutic approach to manage
      CIPN-NP.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Sensory pain
time frame: 13 weeks
description: Thermal, mechanical, and vibration sensation by quantitative sensory testing
measure: Nerve fiber density
time frame: 13 weeks
description: laboratory examination of skin biopsy samples for measurement of nerve fiber density
arm group label: control
arm group type: Other
description: This is an attention control group with regular contact by study staff.
arm group label: aerobic exercise
arm group type: Experimental
description: Aerobic exercise intervention is for 12 weeks 3 times weekly with training on site.
arm group label: resistive training
arm group type: Experimental
description: Intervention is for 12 weeks 3 times weekly with training on site.
intervention type: Behavioral
intervention name: aerobic exercise intervention
description: Exercise physiologist supervised walking or running on the treadmill 3 times weekly for 12 weeks.
arm group label: aerobic exercise
intervention type: Other
intervention name: control group
description: weekly contact by study staff with survivorship information offered not related to neuropathy.
arm group label: control
intervention type: Behavioral
intervention name: resistive training
description: Exercise physiologist supervised upper and lower extremity resistive training 3 times weekly for 12 weeks
arm group label: resistive training
criteria: 
gender: All
minimum age: 21 Years
maximum age: 70 Years
healthy volunteers: No
last name: Alice Ryan, PhD
role: Principal Investigator
affiliation: University of Maryland at Baltimore School of Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Baltimore VA Medical Center
investigator full name: Alice S. Ryan, PhD
investigator title: Professor
mesh term: Breast Neoplasms
mesh term: Lung Neoplasms
mesh term: Ovarian Neoplasms
mesh term: Colorectal Neoplasms
mesh term: Neuralgia
sharing ipd: Undecided