<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/NCT03289364</url>
  </required_header>
  <id_info>
    <org_study_id>2017000277</org_study_id>
    <nct_id>NCT03289364</nct_id>
  </id_info>
  <brief_title>Penguin Cold Caps in the Prevention of Hair Loss in Breast Cancer Patients</brief_title>
  <official_title>A Phase 2 Study to Assess the Safety and Efficacy of Scalp Cooling Using PenguinTM Cold Caps for the Prevention or Reduction of Chemotherapy-induced Alopecia in Stage I-III Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Providence Health &amp; Services</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medical Specialties of California</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Providence Health &amp; Services</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 study is to estimate the efficacy of Penguin cold caps in preventing or&#xD;
      reducing hair loss in patients receiving (neo)adjuvant chemotherapy (one of four common&#xD;
      regimens) for early stage breast cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a phase II prospective, open label, non-randomized study conducted to determine&#xD;
      the safety and efficacy of Penguin TM cold cap system in preventing or reducing&#xD;
      chemotherapy-induced alopecia in patients with early stage breast cancer undergoing&#xD;
      chemotherapy.&#xD;
&#xD;
      Eligible subjects will be enrolled to one of 4 study arms (Table 5) determined by type of&#xD;
      chemotherapy. Subjects will have early stage breast cancer of any receptor subtype, for which&#xD;
      standard of care includes chemotherapy. Eligible subjects will be enrolled at Providence&#xD;
      Portland Medical Center (PPMC) and Providence St. Vincent Medical Center (PSVMC).&#xD;
&#xD;
      The PenguinTM cold cap therapy will be administered to all enrolled subjects according to the&#xD;
      dosing schedule specified by the study arms. PenguinTM cold caps is a portable scalp cooling&#xD;
      system which uses gel-filled cold caps that are cooled on dry ice and exchanged every 30&#xD;
      minutes in order to maintain optimum temperature. Its unique crylon gel formula is&#xD;
      specifically created to maintain cold temperatures for much longer periods of time than other&#xD;
      conventional cooling gels and foams. No scalp preparation is required before use.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">August 24, 2017</start_date>
  <completion_date type="Anticipated">January 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">January 1, 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>
    <intervention_model_description>Patients will use the Penguin Cold Caps during prior to, during, and after chemotherapy administration. Cold-cap therapy will commence at least 50 minutes prior to infusion, and will continue for 4 hours following completion of chemotherapy.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Deans Alopecia Scale</measure>
    <time_frame>30 days post chemotherapy treatment</time_frame>
    <description>Number of patients who score from 0-2 on Deans Alopecia Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Was it Worth it Questionnaire</measure>
    <time_frame>30 days post chemotherapy treatment</time_frame>
    <description>Number of patients reporting positive or beneficial effects of Cold Cap therapy on the Was it Worth it Questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30</measure>
    <time_frame>30 days post chemotherapy treatment</time_frame>
    <description>Number of patients reporting positive or beneficial effects of Cold Cap therapy on the EORTC QLQ-C30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Image Scale Questionnaire</measure>
    <time_frame>30 days post chemotherapy treatment</time_frame>
    <description>These outcomes will be reported as the proportion of patients (and confidence intervals) reporting the study cold-cap therapy as positive and beneficial on the Body Image Scale Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Common Terminology Criteria for Adverse Events (CTCAE) v4.0</measure>
    <time_frame>30 days post chemotherapy treatment</time_frame>
    <description>The proportion of patients (and confidence intervals) with grade 1 or 2 alopecia according to CTCAE rating scale</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Penguin Cold Caps</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Penguin Cold-cap therapy will commence at least 50 minutes prior to chemotherapy infusion, and will continue for 4 hours following completion of chemotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Penguin Cold Caps</intervention_name>
    <description>Patients will wear Penguin Cold Cap scalp cooling device prior to each chemotherapy administration, during administration, and for four hours following administration.</description>
    <arm_group_label>Penguin Cold Caps</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least ≥ 18 years of age&#xD;
&#xD;
          -  Diagnosis of stage I-III breast cancer for whom neoadjuvant or adjuvant cytotoxic&#xD;
             chemotherapy (ACT/HP, TCH/P, TC, or T/H) is planned.&#xD;
&#xD;
          -  Willing and able to provide informed consent.&#xD;
&#xD;
          -  Availability of caretaker(s) to accompany participant and facilitate cold-cap&#xD;
             placement/exchanges using the recommended technique.&#xD;
&#xD;
          -  Women of childbearing potential must use acceptable measures to avoid becoming&#xD;
             pregnant during study period and for 30 days after last dose of chemotherapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre-existing alopecia (Dean's scale ≥ 1)&#xD;
&#xD;
          -  Another malignancy that required active treatment with systemic chemotherapy within 2&#xD;
             years of study recruitment.&#xD;
&#xD;
          -  Prior radiotherapy treatment involving head.&#xD;
&#xD;
          -  Pre-existing chronic severe headaches or migraines.&#xD;
&#xD;
          -  Skin conditions that in the opinion of PI would be at risk of worsening with study.&#xD;
&#xD;
          -  Cold sensitivity or cold agglutinin disease&#xD;
&#xD;
          -  Cryoglobulinemia&#xD;
&#xD;
          -  Cryofibrogenemia&#xD;
&#xD;
          -  History of current evidence of any condition, therapy or abnormality that might&#xD;
             confound the results of the trial, interfere with the subject's participation for the&#xD;
             full duration of the trial, such that trial participation is not in the best interest&#xD;
             of the subject.&#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>David Page, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Providence Health &amp; Services</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Providence Cancer Center</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>September 14, 2020</last_update_submitted>
  <last_update_submitted_qc>September 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breast Cancer</keyword>
  <keyword>Alopecia</keyword>
  <keyword>Hair Loss</keyword>
  <keyword>Scalp Cooling</keyword>
  <keyword>Penguin Cold Caps</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>January 31, 2022</submitted>
    <returned>April 6, 2022</returned>
    <submitted>April 25, 2022</submitted>
    <returned>January 25, 2023</returned>
    <submitted>January 27, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03289364
org study id: 2017000277
nct id: NCT03289364
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this study is to estimate the efficacy of Penguin cold caps in preventing or
      reducing hair loss in patients receiving (neo)adjuvant chemotherapy (one of four common
      regimens) for early stage breast cancer.
This will be a phase II prospective, open label, non-randomized study conducted to determine
      the safety and efficacy of Penguin TM cold cap system in preventing or reducing
      chemotherapy-induced alopecia in patients with early stage breast cancer undergoing
      chemotherapy.

      Eligible subjects will be enrolled to one of 4 study arms (Table 5) determined by type of
      chemotherapy. Subjects will have early stage breast cancer of any receptor subtype, for which
      standard of care includes chemotherapy. Eligible subjects will be enrolled at Providence
      Portland Medical Center (PPMC) and Providence St. Vincent Medical Center (PSVMC).

      The PenguinTM cold cap therapy will be administered to all enrolled subjects according to the
      dosing schedule specified by the study arms. PenguinTM cold caps is a portable scalp cooling
      system which uses gel-filled cold caps that are cooled on dry ice and exchanged every 30
      minutes in order to maintain optimum temperature. Its unique crylon gel formula is
      specifically created to maintain cold temperatures for much longer periods of time than other
      conventional cooling gels and foams. No scalp preparation is required before use.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Patients will use the Penguin Cold Caps during prior to, during, and after chemotherapy administration. Cold-cap therapy will commence at least 50 minutes prior to infusion, and will continue for 4 hours following completion of chemotherapy.
primary purpose: Prevention
masking: None (Open Label)
measure: Deans Alopecia Scale
time frame: 30 days post chemotherapy treatment
description: Number of patients who score from 0-2 on Deans Alopecia Scale
measure: Was it Worth it Questionnaire
time frame: 30 days post chemotherapy treatment
description: Number of patients reporting positive or beneficial effects of Cold Cap therapy on the Was it Worth it Questionnaire.
measure: European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30
time frame: 30 days post chemotherapy treatment
description: Number of patients reporting positive or beneficial effects of Cold Cap therapy on the EORTC QLQ-C30
measure: Body Image Scale Questionnaire
time frame: 30 days post chemotherapy treatment
description: These outcomes will be reported as the proportion of patients (and confidence intervals) reporting the study cold-cap therapy as positive and beneficial on the Body Image Scale Questionnaire
measure: Common Terminology Criteria for Adverse Events (CTCAE) v4.0
time frame: 30 days post chemotherapy treatment
description: The proportion of patients (and confidence intervals) with grade 1 or 2 alopecia according to CTCAE rating scale
arm group label: Penguin Cold Caps
arm group type: Experimental
description: Penguin Cold-cap therapy will commence at least 50 minutes prior to chemotherapy infusion, and will continue for 4 hours following completion of chemotherapy.
intervention type: Device
intervention name: Penguin Cold Caps
description: Patients will wear Penguin Cold Cap scalp cooling device prior to each chemotherapy administration, during administration, and for four hours following administration.
arm group label: Penguin Cold Caps
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Page, MD
role: Principal Investigator
affiliation: Providence Health & Services
facility: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No
submitted: January 31, 2022
returned: April 6, 2022
submitted: April 25, 2022
returned: January 25, 2023
submitted: January 27, 2023