xml: <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/NCT06020222</url>
    </required_header>
    <id_info>
      <org_study_id>KMUHIRB-F(I)-20230041</org_study_id>
      <secondary_id>TWNA-1121020</secondary_id>
      <nct_id>NCT06020222</nct_id>
    </id_info>
    <brief_title>The Effect of Cryotherapy on Breast Cancer Patients</brief_title>
    <official_title>The Effect of Cryotherapy on Breast Cancer Patients in Kaohsiung Medical University Hospital</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kaohsiung Medical University Chung-Ho Memorial Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Taiwan Nurses Association</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Kaohsiung Medical University Chung-Ho Memorial Hospital</source>
    <oversight_info>
      <has_dmc>No</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>
        The goal of this clinical trial is to test the effect of cryotherpay on chemotherapy-induced&#xD;
        peripheral neuropathy(CIPN) among Breast Cancer Patients. The main questions of research are:&#xD;
  &#xD;
          -  Does cryotherapy reduce the incidence of CIPN?&#xD;
  &#xD;
          -  Does cryotherapy reduce the severity of CIPN and improve the quality of life?&#xD;
             Participants will be put on the cold gloves and boots during chemotherapy injection&#xD;
             process and total 90 minutes.&#xD;
  &#xD;
        If there is a comparison group: Researchers will compare usual care group to make sure if it&#xD;
        effects of CIPN.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is designed as a experiment study. In a medical center and breast ward, a&#xD;
        randomized controlled trial was used to evaluate the effect of cryotherapy. Block sampling&#xD;
        was adopted, and participants total 94 were included. Patients were randomly assigned to the&#xD;
        croytherapy group (n=47) or the usual care group(n=47). Both hands and feet received&#xD;
        cryotherapy, and the frequency was once every three weeks. Each cycle was 90-150 minutes, and&#xD;
        the cycle was performed 4-8 times. The instrument included EPRTC QLQ-CIPN20, PNQ, and EORTC&#xD;
        QLQ-C30. After 12-32 weeks, the cryotherapy received qualitative interviews to collect&#xD;
        experience and perceptions. Quantitaitve data were constructed and analyzed with SPSS 20.0&#xD;
        version, and Chi-square test was used to detect the incidence of CIPN after three months.&#xD;
        Mixed linear model was used to detect the severity of peripheral neuropathy symptoms and&#xD;
        quality of life. Survival analysis was used to compare the occurrence time of peripheral&#xD;
        neuropathy events between groups.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 1, 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>Prevention</primary_purpose>
      <masking>Single (Investigator)</masking>
      <masking_description>Assessors don't know groups</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Patient neurotoxicity questionnaire (PNQ)</measure>
      <time_frame>first day</time_frame>
      <description>the incidence of sensory and motor neuropathy, the Grade A to E, the higher the grade, the more serious</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient neurotoxicity questionnaire (PNQ)</measure>
      <time_frame>the day after the first chemotherapy</time_frame>
      <description>the incidence of sensory and motor neuropathy,the Grade A to E, the higher the grade, the more serious</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient neurotoxicity questionnaire (PNQ)</measure>
      <time_frame>the day after the second chemotherapy</time_frame>
      <description>the incidence of sensory and motor neuropathy,the Grade A to E, the higher the grade, the more serious</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient neurotoxicity questionnaire (PNQ)</measure>
      <time_frame>the day after the third chemotherapy</time_frame>
      <description>the incidence of sensory and motor neuropathy,the Grade A to E, the higher the grade, the more serious</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient neurotoxicity questionnaire (PNQ)</measure>
      <time_frame>the day after the fourth chemotherapy</time_frame>
      <description>the incidence of sensory and motor neuropathy,the Grade A to E, the higher the grade, the more serious</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>European Organization for Research and Treatment of Cancer quality of life questionnaire-chemotherapy-induced peripheral neuropathy 20</measure>
      <time_frame>first day</time_frame>
      <description>the severity of Chemotherapy-induced peripheral neuropathy (CIPN), the higher score, the more severe</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>European Organization for Research and Treatment of Cancer quality of life questionnaire-chemotherapy-induced peripheral neuropathy 20</measure>
      <time_frame>the day after the first chemotherapy</time_frame>
      <description>the severity of Chemotherapy-induced peripheral neuropathy (CIPN), the higher score, the more severe</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>European Organization for Research and Treatment of Cancer quality of life questionnaire-chemotherapy-induced peripheral neuropathy 20</measure>
      <time_frame>the day after the second chemotherapy</time_frame>
      <description>the severity of Chemotherapy-induced peripheral neuropathy (CIPN), the higher score, the more severe</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>European Organization for Research and Treatment of Cancer quality of life questionnaire-chemotherapy-induced peripheral neuropathy 20</measure>
      <time_frame>the day after the third chemotherapy</time_frame>
      <description>the severity of Chemotherapy-induced peripheral neuropathy (CIPN), the higher score, the more severe</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>European Organization for Research and Treatment of Cancer quality of life questionnaire-chemotherapy-induced peripheral neuropathy 20</measure>
      <time_frame>the day after the fourth chemotherapy</time_frame>
      <description>the severity of Chemotherapy-induced peripheral neuropathy (CIPN), the higher score, the more severe</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>European Organization for the Research and Treatment of Cancer core questionnaire QLQ30</measure>
      <time_frame>first day</time_frame>
      <description>the quality of life in breast cancer patients, higher score indicate pooer quality of life</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>European Organization for the Research and Treatment of Cancer core questionnaire QLQ30</measure>
      <time_frame>the day after the first chemotherapy</time_frame>
      <description>the quality of life in breast cancer patients,higher score indicate pooer quality of life</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>European Organization for the Research and Treatment of Cancer core questionnaire QLQ30</measure>
      <time_frame>the day after the second chemotherapy</time_frame>
      <description>the quality of life in breast cancer patients,higher score indicate pooer quality of life</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>European Organization for the Research and Treatment of Cancer core questionnaire QLQ30</measure>
      <time_frame>the day after the third chemotherapy</time_frame>
      <description>the quality of life in breast cancer patients,higher score indicate pooer quality of life</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>European Organization for the Research and Treatment of Cancer core questionnaire QLQ30</measure>
      <time_frame>the day after the fourth chemotherapy</time_frame>
      <description>the quality of life in breast cancer patients,higher score indicate pooer quality of life</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>TNSc(Total Neuropathy Score)</measure>
      <time_frame>first day</time_frame>
      <description>the severity of Chemotherapy-induced peripheral neuropathy (CIPN), the higher the score, the more severe the peripheal neuropathy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>TNSc(Total Neuropathy Score)</measure>
      <time_frame>the day after the first chemotherapy</time_frame>
      <description>the severity of Chemotherapy-induced peripheral neuropathy (CIPN),the higher the score, the more severe the peripheal neuropathy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>TNSc(Total Neuropathy Score)</measure>
      <time_frame>the day after the second chemotherapy</time_frame>
      <description>the severity of Chemotherapy-induced peripheral neuropathy (CIPN),the higher the score, the more severe the peripheal neuropathy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>TNSc(Total Neuropathy Score)</measure>
      <time_frame>the day after the third chemotherapy</time_frame>
      <description>the severity of Chemotherapy-induced peripheral neuropathy (CIPN),the higher the score, the more severe the peripheal neuropathy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>TNSc(Total Neuropathy Score)</measure>
      <time_frame>the day after the fourth chemotherapy</time_frame>
      <description>the severity of Chemotherapy-induced peripheral neuropathy (CIPN),the higher the score, the more severe the peripheal neuropathy</description>
    </secondary_outcome>
    <other_outcome>
      <measure>the adverse event and discomfort</measure>
      <time_frame>the day after the first cryotherapy</time_frame>
      <description>the incidence of adverse event and discomfort during cryotherapy</description>
    </other_outcome>
    <other_outcome>
      <measure>the adverse event and discomfort</measure>
      <time_frame>the day after the second cryotherapy</time_frame>
      <description>the incidence of adverse event and discomfort during cryotherapy</description>
    </other_outcome>
    <other_outcome>
      <measure>the adverse event and discomfort</measure>
      <time_frame>the day after the third cryotherapy</time_frame>
      <description>the incidence of adverse event and discomfort during cryotherapy, the more times, the more frequent side effect</description>
    </other_outcome>
    <other_outcome>
      <measure>the adverse event and discomfort</measure>
      <time_frame>the day after the fourth cryotherapy</time_frame>
      <description>the incidence of adverse event and discomfort during cryotherapy,the more times, the more frequent side effect</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">94</enrollment>
    <condition>Chemotherapy-induced Peripheral Neuropathy</condition>
    <arm_group>
      <arm_group_label>Cryotherapy group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Both hands and feet received cryotherapy gloves and boots</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual care group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>health education leaflets</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>cryotherapy</intervention_name>
      <description>Both hands and feet received cryotherapy gloves and boots, and the frequency was once every three weeks. Each cycle was 90 minutes, and the cycle was performed 4 times.</description>
      <arm_group_label>Cryotherapy group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>education</intervention_name>
      <description>Provide preventive CIPN education leaflets</description>
      <arm_group_label>Usual care group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Clinical diagnosis of Breast cancer stage I-III, first time receive paclitaxel&#xD;
               neurotoxic chemotherapy, consciousness clear, able to communicate in Taiwanese or&#xD;
               Mandarin&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Insulin depent diabetes, Raynaud's disease, cold urticaria disease, cryoglobulinemia&#xD;
               and sclerosing basal cell carcinoma, those diagnosed with mental illness, and those&#xD;
               with visual or hearing impairments.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Tsai-Rung Lin, Master</last_name>
      <role>Principal Investigator</role>
      <affiliation>Kaohsiung Medical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Tsai-Rung Lin, Master</last_name>
      <phone>07-31211014</phone>
      <phone_ext>7481</phone_ext>
      <email>920410@kmuh.org.tw</email>
    </overall_contact>
    <location>
      <facility>
        <name>Tsai-Rung Lin</name>
        <address>
          <city>Kaohsiung</city>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Tsai Rung Lin, Master</last_name>
        <phone>07-3121101</phone>
        <phone_ext>7481</phone_ext>
        <email>920410@kmuh.org.tw</email>
      </contact>
      <investigator>
        <last_name>Yun-Han Lee, Master</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Yu-Ying Huang, Master</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Hsin-Tien Hsu, Phd</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>May 2023</verification_date>
    <study_first_submitted>May 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 27, 2023</last_update_submitted>
    <last_update_submitted_qc>August 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>breast cancer</keyword>
    <keyword>chemotherapy</keyword>
    <keyword>neuropathy</keyword>
    <keyword>cryotherapy</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>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06020222
  org study id: KMUHIRB-F(I)-20230041
  secondary id: TWNA-1121020
  nct id: NCT06020222
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to test the effect of cryotherpay on chemotherapy-induced
        peripheral neuropathy(CIPN) among Breast Cancer Patients. The main questions of research are:
  
          -  Does cryotherapy reduce the incidence of CIPN?
  
          -  Does cryotherapy reduce the severity of CIPN and improve the quality of life?
             Participants will be put on the cold gloves and boots during chemotherapy injection
             process and total 90 minutes.
  
        If there is a comparison group: Researchers will compare usual care group to make sure if it
        effects of CIPN.
  This study is designed as a experiment study. In a medical center and breast ward, a
        randomized controlled trial was used to evaluate the effect of cryotherapy. Block sampling
        was adopted, and participants total 94 were included. Patients were randomly assigned to the
        croytherapy group (n=47) or the usual care group(n=47). Both hands and feet received
        cryotherapy, and the frequency was once every three weeks. Each cycle was 90-150 minutes, and
        the cycle was performed 4-8 times. The instrument included EPRTC QLQ-CIPN20, PNQ, and EORTC
        QLQ-C30. After 12-32 weeks, the cryotherapy received qualitative interviews to collect
        experience and perceptions. Quantitaitve data were constructed and analyzed with SPSS 20.0
        version, and Chi-square test was used to detect the incidence of CIPN after three months.
        Mixed linear model was used to detect the severity of peripheral neuropathy symptoms and
        quality of life. Survival analysis was used to compare the occurrence time of peripheral
        neuropathy events between groups.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Investigator)
  masking description: Assessors don't know groups
  measure: Patient neurotoxicity questionnaire (PNQ)
  time frame: first day
  description: the incidence of sensory and motor neuropathy, the Grade A to E, the higher the grade, the more serious
  measure: Patient neurotoxicity questionnaire (PNQ)
  time frame: the day after the first chemotherapy
  description: the incidence of sensory and motor neuropathy,the Grade A to E, the higher the grade, the more serious
  measure: Patient neurotoxicity questionnaire (PNQ)
  time frame: the day after the second chemotherapy
  description: the incidence of sensory and motor neuropathy,the Grade A to E, the higher the grade, the more serious
  measure: Patient neurotoxicity questionnaire (PNQ)
  time frame: the day after the third chemotherapy
  description: the incidence of sensory and motor neuropathy,the Grade A to E, the higher the grade, the more serious
  measure: Patient neurotoxicity questionnaire (PNQ)
  time frame: the day after the fourth chemotherapy
  description: the incidence of sensory and motor neuropathy,the Grade A to E, the higher the grade, the more serious
  measure: European Organization for Research and Treatment of Cancer quality of life questionnaire-chemotherapy-induced peripheral neuropathy 20
  time frame: first day
  description: the severity of Chemotherapy-induced peripheral neuropathy (CIPN), the higher score, the more severe
  measure: European Organization for Research and Treatment of Cancer quality of life questionnaire-chemotherapy-induced peripheral neuropathy 20
  time frame: the day after the first chemotherapy
  description: the severity of Chemotherapy-induced peripheral neuropathy (CIPN), the higher score, the more severe
  measure: European Organization for Research and Treatment of Cancer quality of life questionnaire-chemotherapy-induced peripheral neuropathy 20
  time frame: the day after the second chemotherapy
  description: the severity of Chemotherapy-induced peripheral neuropathy (CIPN), the higher score, the more severe
  measure: European Organization for Research and Treatment of Cancer quality of life questionnaire-chemotherapy-induced peripheral neuropathy 20
  time frame: the day after the third chemotherapy
  description: the severity of Chemotherapy-induced peripheral neuropathy (CIPN), the higher score, the more severe
  measure: European Organization for Research and Treatment of Cancer quality of life questionnaire-chemotherapy-induced peripheral neuropathy 20
  time frame: the day after the fourth chemotherapy
  description: the severity of Chemotherapy-induced peripheral neuropathy (CIPN), the higher score, the more severe
  measure: European Organization for the Research and Treatment of Cancer core questionnaire QLQ30
  time frame: first day
  description: the quality of life in breast cancer patients, higher score indicate pooer quality of life
  measure: European Organization for the Research and Treatment of Cancer core questionnaire QLQ30
  time frame: the day after the first chemotherapy
  description: the quality of life in breast cancer patients,higher score indicate pooer quality of life
  measure: European Organization for the Research and Treatment of Cancer core questionnaire QLQ30
  time frame: the day after the second chemotherapy
  description: the quality of life in breast cancer patients,higher score indicate pooer quality of life
  measure: European Organization for the Research and Treatment of Cancer core questionnaire QLQ30
  time frame: the day after the third chemotherapy
  description: the quality of life in breast cancer patients,higher score indicate pooer quality of life
  measure: European Organization for the Research and Treatment of Cancer core questionnaire QLQ30
  time frame: the day after the fourth chemotherapy
  description: the quality of life in breast cancer patients,higher score indicate pooer quality of life
  measure: TNSc(Total Neuropathy Score)
  time frame: first day
  description: the severity of Chemotherapy-induced peripheral neuropathy (CIPN), the higher the score, the more severe the peripheal neuropathy
  measure: TNSc(Total Neuropathy Score)
  time frame: the day after the first chemotherapy
  description: the severity of Chemotherapy-induced peripheral neuropathy (CIPN),the higher the score, the more severe the peripheal neuropathy
  measure: TNSc(Total Neuropathy Score)
  time frame: the day after the second chemotherapy
  description: the severity of Chemotherapy-induced peripheral neuropathy (CIPN),the higher the score, the more severe the peripheal neuropathy
  measure: TNSc(Total Neuropathy Score)
  time frame: the day after the third chemotherapy
  description: the severity of Chemotherapy-induced peripheral neuropathy (CIPN),the higher the score, the more severe the peripheal neuropathy
  measure: TNSc(Total Neuropathy Score)
  time frame: the day after the fourth chemotherapy
  description: the severity of Chemotherapy-induced peripheral neuropathy (CIPN),the higher the score, the more severe the peripheal neuropathy
  measure: the adverse event and discomfort
  time frame: the day after the first cryotherapy
  description: the incidence of adverse event and discomfort during cryotherapy
  measure: the adverse event and discomfort
  time frame: the day after the second cryotherapy
  description: the incidence of adverse event and discomfort during cryotherapy
  measure: the adverse event and discomfort
  time frame: the day after the third cryotherapy
  description: the incidence of adverse event and discomfort during cryotherapy, the more times, the more frequent side effect
  measure: the adverse event and discomfort
  time frame: the day after the fourth cryotherapy
  description: the incidence of adverse event and discomfort during cryotherapy,the more times, the more frequent side effect
  arm group label: Cryotherapy group
  arm group type: Experimental
  description: Both hands and feet received cryotherapy gloves and boots
  arm group label: Usual care group
  arm group type: Placebo Comparator
  description: health education leaflets
  intervention type: Device
  intervention name: cryotherapy
  description: Both hands and feet received cryotherapy gloves and boots, and the frequency was once every three weeks. Each cycle was 90 minutes, and the cycle was performed 4 times.
  arm group label: Cryotherapy group
  intervention type: Other
  intervention name: education
  description: Provide preventive CIPN education leaflets
  arm group label: Usual care group
  criteria: 
  gender: Female
  minimum age: 20 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Tsai-Rung Lin, Master
  role: Principal Investigator
  affiliation: Kaohsiung Medical University
  last name: Tsai-Rung Lin, Master
  phone: 07-31211014
  phone ext: 7481
  email: 920410@kmuh.org.tw
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  country: Taiwan
  responsible party type: Sponsor
  mesh term: Peripheral Nervous System Diseases
  sharing ipd: No