<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/NCT03299582</url>
  </required_header>
  <id_info>
    <org_study_id>2013/00343</org_study_id>
    <nct_id>NCT03299582</nct_id>
  </id_info>
  <brief_title>PREventing CHemotherapy Induced Neuropathy (PreChIN)</brief_title>
  <official_title>PREventing CHemotherapy Induced Neuropathy (PreChIN)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National University Hospital, Singapore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National University Hospital, Singapore</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 project is designed to study the use of localized hypothermia alone, or with compression&#xD;
      to the limbs during chemotherapy infusion for the prevention of chemotherapy induced&#xD;
      peripheral neuropathy (CIPN). As a pilot study, safety, tolerability and early clinical&#xD;
      activity will be studied. The study will be conducted on healthy volunteers and cancer&#xD;
      patients receiving taxane chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Localized limb hypothermia during chemotherapeutic infusion may prevent a common side effect&#xD;
      of chemotherapy: chemotherapy-induced peripheral neuropathy (CIPN). There are no reliable&#xD;
      methods for the prevention or the treatment of CIPN. On the basis of the dose-related&#xD;
      pathophysiology of CIPN, the investigators hypothesize that reducing the delivery of the&#xD;
      toxic chemotherapeutic agents to the peripheral nerves by reducing blood flow through&#xD;
      hypothermia may reduce the occurrence of CIPN. The proposed potential treatment method would&#xD;
      aim to reduce the development of CIPN. This project comprises of a healthy subject trial to&#xD;
      investigate the best tolerated temperature which will be used in cancer subject trial to&#xD;
      investigate the safety and tolerability of hypothermia or cryocompression (hypothermia with&#xD;
      pressure) in the prevention of CIPN in cancer subjects undergoing taxane-based chemotherapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 13, 2013</start_date>
  <completion_date type="Actual">February 15, 2017</completion_date>
  <primary_completion_date type="Actual">November 3, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>The first part of this study is in healthy subjects, followed by breast cancer patients receiving paclitaxel to study the effect of limb hypothermia in the prevention of chemotherapy-induced neuropathy.&#xD;
The second part of this study is to study the effect of cryocompression in the prevention of chemotherapy-induced neuropathy.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of healthy subjects with treatment-related intolerance as assessed by CTCAE v4.0 and tolerability scales undergoing limb hypothermia or cryocompression</measure>
    <time_frame>From the start of assessment until study completion, an average of 3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of cancer patients with treatment-related intolerance as assessed by CTCAE v4.0 and tolerability scales undergoing limb hypothermia or cryocompression</measure>
    <time_frame>From the start of assessment until study completion, an average of 3 years</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">89</enrollment>
  <condition>Chemotherapy-induced Peripheral Neuropathy (CIPN)</condition>
  <arm_group>
    <arm_group_label>Healthy subjects (Hypothermia)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To investigate the safety and tolerability of limb hypothermia in subjects without cancer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy subjects (Cryocompresion)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To investigate the safety and tolerability of cryocompression in subjects without cancer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cancer subjects (Hypothermia)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To investigate the safety and tolerability of limb hypothermia in subjects with breast cancer being treated with paclitaxel chemotherapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cancer subjects (Cryocompresion)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To investigate the safety and tolerability of cryocompression in subjects with cancer being treated with taxane-based chemotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hypothermia</intervention_name>
    <description>Healthy subjects will undergo 3 hours of hypothermia at various temperature levels.Cancer subjects will undergo 4 hours of hypothermia during every cycle of chemotherapy.</description>
    <arm_group_label>Cancer subjects (Hypothermia)</arm_group_label>
    <arm_group_label>Healthy subjects (Hypothermia)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cryocompression</intervention_name>
    <description>Healthy subjects will undergo 3 hours of cryocompression. Cancer subjects will undergo a minimum duration of 2 hours and a maximum duration of up to 4 hours of cryocompression during every cycle of chemotherapy.</description>
    <arm_group_label>Cancer subjects (Cryocompresion)</arm_group_label>
    <arm_group_label>Healthy subjects (Cryocompresion)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        The inclusion criterion for the healthy subjects&#xD;
&#xD;
          -  Age 21-80 years&#xD;
&#xD;
          -  Signed informed consent from patient&#xD;
&#xD;
          -  No history of neuropathy&#xD;
&#xD;
          -  ECOG 0&#xD;
&#xD;
          -  No history of hospitalization in the past 6 months&#xD;
&#xD;
        The inclusion criteria for the cancer patients undergoing taxane-based chemotherapy&#xD;
&#xD;
          -  Age 21- 80 years.&#xD;
&#xD;
          -  Signed informed consent from patient or legal representative.&#xD;
&#xD;
          -  Scheduled to receive taxane-based chemotherapy&#xD;
&#xD;
        The exclusion criteria for both healthy subjects and cancer patients&#xD;
&#xD;
          -  Open skin wound or ulcers of the limbs&#xD;
&#xD;
          -  A score of more than 5 in the Total Neuropathy Score (TNS) at baseline (Not applicable&#xD;
             for healthy subjects)&#xD;
&#xD;
          -  History of Raynaud's phenomenon, peripheral vascular disease, or poorly controlled&#xD;
             diabetes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amanda Chan</last_name>
    <role>Principal Investigator</role>
    <affiliation>National University Hospital, Singapore</affiliation>
  </overall_official>
  <reference>
    <citation>Tomchuk D, Rubley MD, Holcomb WR, Guadagnoli M, Tarno JM. The magnitude of tissue cooling during cryotherapy with varied types of compression. J Athl Train. 2010 May-Jun;45(3):230-7. doi: 10.4085/1062-6050-45.3.230.</citation>
    <PMID>20446835</PMID>
  </reference>
  <reference>
    <citation>Murgier J, Cassard X. Cryotherapy with dynamic intermittent compression for analgesia after anterior cruciate ligament reconstruction. Preliminary study. Orthop Traumatol Surg Res. 2014 May;100(3):309-12. doi: 10.1016/j.otsr.2013.12.019. Epub 2014 Mar 25.</citation>
    <PMID>24679367</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>October 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>October 1, 2017</last_update_submitted>
  <last_update_submitted_qc>October 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>paclitaxel</keyword>
  <keyword>neuropathy</keyword>
  <keyword>hypothermia</keyword>
  <keyword>cryocompression</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>


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/NCT03299582
org study id: 2013/00343
nct id: NCT03299582
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The project is designed to study the use of localized hypothermia alone, or with compression
      to the limbs during chemotherapy infusion for the prevention of chemotherapy induced
      peripheral neuropathy (CIPN). As a pilot study, safety, tolerability and early clinical
      activity will be studied. The study will be conducted on healthy volunteers and cancer
      patients receiving taxane chemotherapy.
Localized limb hypothermia during chemotherapeutic infusion may prevent a common side effect
      of chemotherapy: chemotherapy-induced peripheral neuropathy (CIPN). There are no reliable
      methods for the prevention or the treatment of CIPN. On the basis of the dose-related
      pathophysiology of CIPN, the investigators hypothesize that reducing the delivery of the
      toxic chemotherapeutic agents to the peripheral nerves by reducing blood flow through
      hypothermia may reduce the occurrence of CIPN. The proposed potential treatment method would
      aim to reduce the development of CIPN. This project comprises of a healthy subject trial to
      investigate the best tolerated temperature which will be used in cancer subject trial to
      investigate the safety and tolerability of hypothermia or cryocompression (hypothermia with
      pressure) in the prevention of CIPN in cancer subjects undergoing taxane-based chemotherapy.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: The first part of this study is in healthy subjects, followed by breast cancer patients receiving paclitaxel to study the effect of limb hypothermia in the prevention of chemotherapy-induced neuropathy.
The second part of this study is to study the effect of cryocompression in the prevention of chemotherapy-induced neuropathy.
primary purpose: Prevention
masking: None (Open Label)
measure: Number of healthy subjects with treatment-related intolerance as assessed by CTCAE v4.0 and tolerability scales undergoing limb hypothermia or cryocompression
time frame: From the start of assessment until study completion, an average of 3 years
measure: Number of cancer patients with treatment-related intolerance as assessed by CTCAE v4.0 and tolerability scales undergoing limb hypothermia or cryocompression
time frame: From the start of assessment until study completion, an average of 3 years
arm group label: Healthy subjects (Hypothermia)
arm group type: Experimental
description: To investigate the safety and tolerability of limb hypothermia in subjects without cancer
arm group label: Healthy subjects (Cryocompresion)
arm group type: Experimental
description: To investigate the safety and tolerability of cryocompression in subjects without cancer
arm group label: Cancer subjects (Hypothermia)
arm group type: Experimental
description: To investigate the safety and tolerability of limb hypothermia in subjects with breast cancer being treated with paclitaxel chemotherapy.
arm group label: Cancer subjects (Cryocompresion)
arm group type: Experimental
description: To investigate the safety and tolerability of cryocompression in subjects with cancer being treated with taxane-based chemotherapy.
intervention type: Device
intervention name: Hypothermia
description: Healthy subjects will undergo 3 hours of hypothermia at various temperature levels.Cancer subjects will undergo 4 hours of hypothermia during every cycle of chemotherapy.
arm group label: Cancer subjects (Hypothermia)
arm group label: Healthy subjects (Hypothermia)
intervention type: Device
intervention name: Cryocompression
description: Healthy subjects will undergo 3 hours of cryocompression. Cancer subjects will undergo a minimum duration of 2 hours and a maximum duration of up to 4 hours of cryocompression during every cycle of chemotherapy.
arm group label: Cancer subjects (Cryocompresion)
arm group label: Healthy subjects (Cryocompresion)
criteria: 
gender: All
minimum age: 21 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Amanda Chan
role: Principal Investigator
affiliation: National University Hospital, Singapore
citation: Tomchuk D, Rubley MD, Holcomb WR, Guadagnoli M, Tarno JM. The magnitude of tissue cooling during cryotherapy with varied types of compression. J Athl Train. 2010 May-Jun;45(3):230-7. doi: 10.4085/1062-6050-45.3.230.
PMID: 20446835
citation: Murgier J, Cassard X. Cryotherapy with dynamic intermittent compression for analgesia after anterior cruciate ligament reconstruction. Preliminary study. Orthop Traumatol Surg Res. 2014 May;100(3):309-12. doi: 10.1016/j.otsr.2013.12.019. Epub 2014 Mar 25.
PMID: 24679367
responsible party type: Sponsor
mesh term: Peripheral Nervous System Diseases
sharing ipd: No