<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/NCT03292328</url>
  </required_header>
  <id_info>
    <org_study_id>17-449</org_study_id>
    <nct_id>NCT03292328</nct_id>
  </id_info>
  <brief_title>Yoga for Symptoms of Nerve Damage Caused by Chemotherapy</brief_title>
  <official_title>Yoga for Chemotherapy-Induced Peripheral Neuropathy in Breast and GYN Cancer Survivors: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</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>
      Some types of chemotherapy used to treat breast cancer can cause damage to nerves with&#xD;
      symptoms like tingling, numbness, muscle weakness, and pain in the hands and feet that can&#xD;
      last and can affect functioning. The purpose of this study is to find out the effects of yoga&#xD;
      on reducing symptoms caused by such nerve damage.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 18, 2017</start_date>
  <completion_date type="Actual">September 15, 2020</completion_date>
  <primary_completion_date type="Actual">September 15, 2020</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in treatment related peripheral neuropathy symptoms</measure>
    <time_frame>8 weeks of the participants' most bothersome peripheral neuropathy symptom</time_frame>
    <description>Treatment related symptoms will be evaluated by using NCI CTCAE v4.0</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Peripheral Neuropathy</condition>
  <condition>Gynecologic Cancer</condition>
  <arm_group>
    <arm_group_label>Yoga Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After randomization, participants in the Yoga group will meet twice weekly for 8 weeks of classes taught by MSK yoga instructors. Each class will last for sixty minutes. In addition to these group classes, participants will utilize a home-based program on the days group classes are not held. The daily home practice will continue for four weeks after the group classes are finished.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait List Control Arm (WLC)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in the WLC group will continue usual care for twelve weeks before participating in Yoga classes for eight weeks. At the end of the twelve week follow-up, these participants will receive eight weeks of group Yoga classes and the home Yoga practice recording. At week 20, they will complete a final follow-up visit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Yoga</intervention_name>
    <description>Participants in the Yoga group will meet twice weekly for 8 weeks of classes taught by MSK yoga instructors. Each class will last for sixty minutes. In addition to these group classes, participants will utilize a home-based program on the days group classes are not held. The daily home practice will continue for four weeks after the group classes are finished.</description>
    <arm_group_label>Yoga Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Wait List Control</intervention_name>
    <description>Participants in the WLC group will continue usual care for twelve weeks before participating in Yoga classes for eight weeks. At the end of the twelve week follow-up, these subjects will receive eight weeks of group Yoga classes and the home Yoga practice recording. At week 20, they will complete a final follow-up visit.</description>
    <arm_group_label>Wait List Control Arm (WLC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
          -  Age &gt;/= 18 years old&#xD;
&#xD;
          -  Survivors with a primary diagnosis of stage I-III breast, ovarian uterine, or&#xD;
             endometrial cancer&#xD;
&#xD;
          -  Moderate to severe chemotherapy induced peripheral neuropathy, defined by symptoms&#xD;
             such as numbness, tingling, or pain ratings of 4 or greater on a 0-10 numeric rating&#xD;
             scale&#xD;
&#xD;
          -  Have completed neurotoxic chemotherapy, i.e. taxanes (paclitaxel, docetaxel) and&#xD;
             platinum (carboplatin) at least 3 months prior to enrollment&#xD;
&#xD;
          -  If taking anti-neuropathy medications, they are on a stable regiment (no change in 3&#xD;
             months)&#xD;
&#xD;
          -  ECOG performance status 0-2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with metastatic disease&#xD;
&#xD;
          -  Participants who are currently receiving physical therapy or practicing yoga for any&#xD;
             reason&#xD;
&#xD;
        Control Group - Inclusion/Exclusion Criteria&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Age &gt;/= 18 years old&#xD;
&#xD;
          -  Survivors with a primary diagnosis of Stage I-III breast, ovarian, uterine, or&#xD;
             endometrial cancer&#xD;
&#xD;
          -  CIPN symptoms such as numbness, tingling, or pain ratings &lt; 2 on a 0-10 NRS scale&#xD;
&#xD;
          -  Have completed neurotoxic chemotherapy, i.e. taxanes (paclitaxel, docetaxel) and&#xD;
             platinum (carboplatin) at least 3 months prior to enrollment&#xD;
&#xD;
          -  ECOG performance status 0-2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with metastatic disease&#xD;
&#xD;
          -  Patients taking anti-neuropathy medication&#xD;
&#xD;
          -  Patients who are currently receiving physical therapy or practicing yoga for any&#xD;
             reason&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ting Bao, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Memoral Sloan Kettering Westchester</name>
      <address>
        <city>Harrison</city>
        <state>New York</state>
        <zip>10604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan - Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>September 16, 2020</last_update_submitted>
  <last_update_submitted_qc>September 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>breast cancer</keyword>
  <keyword>neuropathy</keyword>
  <keyword>peripheral neuropathy</keyword>
  <keyword>yoga</keyword>
  <keyword>17-449</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>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/NCT03292328
org study id: 17-449
nct id: NCT03292328
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Some types of chemotherapy used to treat breast cancer can cause damage to nerves with
      symptoms like tingling, numbness, muscle weakness, and pain in the hands and feet that can
      last and can affect functioning. The purpose of this study is to find out the effects of yoga
      on reducing symptoms caused by such nerve damage.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in treatment related peripheral neuropathy symptoms
time frame: 8 weeks of the participants' most bothersome peripheral neuropathy symptom
description: Treatment related symptoms will be evaluated by using NCI CTCAE v4.0
arm group label: Yoga Arm
arm group type: Experimental
description: After randomization, participants in the Yoga group will meet twice weekly for 8 weeks of classes taught by MSK yoga instructors. Each class will last for sixty minutes. In addition to these group classes, participants will utilize a home-based program on the days group classes are not held. The daily home practice will continue for four weeks after the group classes are finished.
arm group label: Wait List Control Arm (WLC)
arm group type: Active Comparator
description: Participants in the WLC group will continue usual care for twelve weeks before participating in Yoga classes for eight weeks. At the end of the twelve week follow-up, these participants will receive eight weeks of group Yoga classes and the home Yoga practice recording. At week 20, they will complete a final follow-up visit.
intervention type: Other
intervention name: Yoga
description: Participants in the Yoga group will meet twice weekly for 8 weeks of classes taught by MSK yoga instructors. Each class will last for sixty minutes. In addition to these group classes, participants will utilize a home-based program on the days group classes are not held. The daily home practice will continue for four weeks after the group classes are finished.
arm group label: Yoga Arm
intervention type: Other
intervention name: Wait List Control
description: Participants in the WLC group will continue usual care for twelve weeks before participating in Yoga classes for eight weeks. At the end of the twelve week follow-up, these subjects will receive eight weeks of group Yoga classes and the home Yoga practice recording. At week 20, they will complete a final follow-up visit.
arm group label: Wait List Control Arm (WLC)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ting Bao, MD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
facility: 
facility: 
country: United States
url: http://www.mskcc.org
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Peripheral Nervous System Diseases
sharing ipd: Undecided