<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/NCT04492800</url>
  </required_header>
  <id_info>
    <org_study_id>HRI-ScalpCooling-001</org_study_id>
    <nct_id>NCT04492800</nct_id>
  </id_info>
  <brief_title>Hair Loss Prevention Study for Pancreatic Cancer</brief_title>
  <official_title>A Hair Loss Prevention Study for Patients With Advanced Pancreatic Cancer Utilizing Scalp Cooling</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HonorHealth Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HonorHealth Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pilot study intended for hair loss prevention in patients with pancreatic cancer who are&#xD;
      receiving treatment containing nab-paclitaxel, gemcitabine and cisplatin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with pancreatic cancer who are receiving treatment containing nab-paclitaxel,&#xD;
      gemcitabine and cisplatin will experience hair preservation with the use of the Paxman scalp&#xD;
      cooling device, at the end of three, 3 week cycles of chemotherapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 13, 2019</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">April 20, 2021</primary_completion_date>
  <phase>N/A</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>Hair Preservation</measure>
    <time_frame>28 to 84 days</time_frame>
    <description>Patients will experience hair preservation defined as alopecia Grade 0 or 1 versus Grade 2 as defined by the CTCAE Version 5.0</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Comfort</measure>
    <time_frame>1 to 84 days</time_frame>
    <description>Patient's comfort while receiving scalp cooling using the Paxman scalp cooling device by asking one Likert scale question (comfortable or uncomfortable)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chemotherapy-Induced Alopecia Distress</measure>
    <time_frame>1 to 84 days</time_frame>
    <description>Identify chemotherapy-induced alopecia distress by utilizing the chemotherapy-induced alopecia distress scale (CADS) with scores ranging from 17-68 with a higher score indicating distress</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Alopecia</condition>
  <arm_group>
    <arm_group_label>Paxman Scalp Cooling Device</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients will undergo scalp cooling via the Paxman Scalp Cooling device for the first 3 cycles of treatment. Cooling will consist of precooling (30 minutes); infusion cooling (will vary depending upon the length of time to infuse the chemotherapy) and post infusion cooling (90 minutes).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Paxman Scalp Cooling Device</intervention_name>
    <description>Cooling will consist of precooling (30 minutes); infusion cooling (will vary depending upon the length of time to infuse the chemotherapy) and post infusion cooling (90 minutes).</description>
    <arm_group_label>Paxman Scalp Cooling Device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willing and able to provide written informed consent/assent for the trial&#xD;
&#xD;
          -  &gt;18 years of age on day of signing informed consent&#xD;
&#xD;
          -  Diagnosis of pancreatic cancer and scheduled to receive treatment with a regimen&#xD;
             containing nab-paclitaxel, gemcitabine and cisplatin&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Grade 1 alopecia&#xD;
&#xD;
          -  Existing history of scalp metastases or the presence of scalp metastases is suspected&#xD;
&#xD;
          -  No history of previous cancers within the past 5 years&#xD;
&#xD;
          -  CNS malignancies (either primary or metastatic)&#xD;
&#xD;
          -  Cold sensitivity, cold agglutinin disease, cryoglobulinemia, cryofibrinogenemia, cold&#xD;
             migraine, cold urticaria, post-traumatic cold dystrophy&#xD;
&#xD;
          -  Imminent bone marrow ablation chemotherapy&#xD;
&#xD;
          -  Imminent skull radiation&#xD;
&#xD;
          -  Previously received or scheduled to undergo skull irradiation&#xD;
&#xD;
          -  Severe liver or renal disease from any etiology as patient may not be able to&#xD;
             metabolize or clear the metabolites of the chemotherapeutic agent&#xD;
&#xD;
          -  Skin cancers including melanoma, squamous cell carcinoma and Merkel cell carcinoma&#xD;
&#xD;
          -  Small cell carcinoma of the lung&#xD;
&#xD;
          -  Solid tumors that have a high likelihood for metastasis in transit&#xD;
&#xD;
          -  Squamous cell carcinoma of the lung&#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>Amy Mirabella, PhD, RN, CHPN</last_name>
    <role>Principal Investigator</role>
    <affiliation>HonorHealth Research Institute - Bisgrove</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>HonorHealth Research Institute</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85258</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>February 22, 2022</last_update_submitted>
  <last_update_submitted_qc>February 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alopecia</mesh_term>
  </condition_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/NCT04492800
org study id: HRI-ScalpCooling-001
nct id: NCT04492800
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Pilot study intended for hair loss prevention in patients with pancreatic cancer who are
      receiving treatment containing nab-paclitaxel, gemcitabine and cisplatin.
Patients with pancreatic cancer who are receiving treatment containing nab-paclitaxel,
      gemcitabine and cisplatin will experience hair preservation with the use of the Paxman scalp
      cooling device, at the end of three, 3 week cycles of chemotherapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Hair Preservation
time frame: 28 to 84 days
description: Patients will experience hair preservation defined as alopecia Grade 0 or 1 versus Grade 2 as defined by the CTCAE Version 5.0
measure: Patient Comfort
time frame: 1 to 84 days
description: Patient's comfort while receiving scalp cooling using the Paxman scalp cooling device by asking one Likert scale question (comfortable or uncomfortable)
measure: Chemotherapy-Induced Alopecia Distress
time frame: 1 to 84 days
description: Identify chemotherapy-induced alopecia distress by utilizing the chemotherapy-induced alopecia distress scale (CADS) with scores ranging from 17-68 with a higher score indicating distress
arm group label: Paxman Scalp Cooling Device
arm group type: Other
description: Patients will undergo scalp cooling via the Paxman Scalp Cooling device for the first 3 cycles of treatment. Cooling will consist of precooling (30 minutes); infusion cooling (will vary depending upon the length of time to infuse the chemotherapy) and post infusion cooling (90 minutes).
intervention type: Device
intervention name: Paxman Scalp Cooling Device
description: Cooling will consist of precooling (30 minutes); infusion cooling (will vary depending upon the length of time to infuse the chemotherapy) and post infusion cooling (90 minutes).
arm group label: Paxman Scalp Cooling Device
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Amy Mirabella, PhD, RN, CHPN
role: Principal Investigator
affiliation: HonorHealth Research Institute - Bisgrove
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alopecia