<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/NCT02230319</url>
  </required_header>
  <id_info>
    <org_study_id>2014.1</org_study_id>
    <nct_id>NCT02230319</nct_id>
  </id_info>
  <brief_title>Prevention of Paclitaxel Neuropathy With Cryotherapy</brief_title>
  <official_title>Prevention of Paclitaxel Neuropathy With Cryotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical Oncology &amp; Hematology Associates of Northern Virginia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Inova Health Care Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical Oncology &amp; Hematology Associates of Northern Virginia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if cryotherapy can effectively decrease the rate of&#xD;
      neuropathy in patients undergoing weekly paclitaxel treatments.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">March 2017</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of grade 2 peripheral neuropathies induced by weekly paclitaxel.</measure>
    <time_frame>From the date of randomization until date of first documented incidence of grade 2 peripheral neuropathy, assessed up to 2 years.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of completion of weekly adjuvant paclitaxel with the use of cryotherapy.</measure>
    <time_frame>From the date of randomization until date of first documented incidence of grade 2 peripheral neuropathy, assessed up to 2 years.</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">39</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Cryotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each patient will receive cryotherapy administered during weekly paclitaxel treatments by Elasto gel™ Hypothermia mitts and slippers. Patients will wear the mitts and slippers for 15 minutes prior to treatment start, for 60 minutes during treatment, and for 15 minutes following treatment completion, for a total of 90 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cryotherapy</intervention_name>
    <arm_group_label>Cryotherapy</arm_group_label>
    <other_name>Cold therapy</other_name>
    <other_name>Elasto gel™</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <arm_group_label>Cryotherapy</arm_group_label>
    <other_name>Taxol</other_name>
    <other_name>Taxanes</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Women 18 years of age or older&#xD;
&#xD;
          2. Histologically or cytological proven diagnosis of breast cancer Stage I- III.&#xD;
&#xD;
          3. Must pl an to receive weekly paclitaxel treatment in either the adjuvant or&#xD;
             neoadjuvant setting.&#xD;
&#xD;
          4. May have received prior treatment including, radiation, surgery chemotherapy hormone&#xD;
             and biologics.&#xD;
&#xD;
          5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1&#xD;
&#xD;
          6. Patient signed informed consent.&#xD;
&#xD;
          7. Patient willing and able to comply with scheduled visits and treatment plan.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Patient presents with Grade 2 or greater peripheral neuropathy.&#xD;
&#xD;
          2. History of Raynaud's Disease.&#xD;
&#xD;
          3. Patient presents open or poorly-healing wounds on the hands or feet.&#xD;
&#xD;
          4. Patients with cold intolerance.&#xD;
&#xD;
          5. Patient has any other concurrent severe and/or uncontrolled medical condition that&#xD;
             would, in the investigator's judgment contraindicate patient participation.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mary J Wilkinson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical Oncology &amp; Hematology Associates of Northern Virginia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical Oncology &amp; Hematology Associates of Northern Virginia</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Oncology &amp; Hematology Associates of Northern Virginia</name>
      <address>
        <city>Reston</city>
        <state>Virginia</state>
        <zip>20190</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>September 30, 2015</last_update_submitted>
  <last_update_submitted_qc>September 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 1, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical Oncology &amp; Hematology Associates of Northern Virginia</investigator_affiliation>
    <investigator_full_name>Mary Wilkinson</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>Cryotherapy</keyword>
  <keyword>Cold therapy</keyword>
  <keyword>Peripheral Neuropathy</keyword>
  <keyword>Paclitaxel</keyword>
  <keyword>Breast Cancer</keyword>
  <keyword>Symptom management</keyword>
  <keyword>Prevention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
  </intervention_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/NCT02230319
org study id: 2014.1
nct id: NCT02230319
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine if cryotherapy can effectively decrease the rate of
      neuropathy in patients undergoing weekly paclitaxel treatments.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Incidence of grade 2 peripheral neuropathies induced by weekly paclitaxel.
time frame: From the date of randomization until date of first documented incidence of grade 2 peripheral neuropathy, assessed up to 2 years.
measure: Rate of completion of weekly adjuvant paclitaxel with the use of cryotherapy.
time frame: From the date of randomization until date of first documented incidence of grade 2 peripheral neuropathy, assessed up to 2 years.
arm group label: Cryotherapy
arm group type: Experimental
description: Each patient will receive cryotherapy administered during weekly paclitaxel treatments by Elasto gel™ Hypothermia mitts and slippers. Patients will wear the mitts and slippers for 15 minutes prior to treatment start, for 60 minutes during treatment, and for 15 minutes following treatment completion, for a total of 90 minutes.
intervention type: Other
intervention name: Cryotherapy
arm group label: Cryotherapy
other name: Cold therapy
other name: Elasto gel™
intervention type: Drug
intervention name: Paclitaxel
arm group label: Cryotherapy
other name: Taxol
other name: Taxanes
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mary J Wilkinson, MD
role: Principal Investigator
affiliation: Medical Oncology & Hematology Associates of Northern Virginia
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Medical Oncology & Hematology Associates of Northern Virginia
investigator full name: Mary Wilkinson
investigator title: Principle Investigator
mesh term: Breast Neoplasms
mesh term: Paclitaxel