<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/NCT03000322</url>
  </required_header>
  <id_info>
    <org_study_id>E-16-680</org_study_id>
    <nct_id>NCT03000322</nct_id>
  </id_info>
  <brief_title>Cooling Vest in Men With Hot Flashes</brief_title>
  <official_title>Investigation of a Cooling Vest in Men With Chemotherapy-Induced Hot Flashes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Englewood Hospital and Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Englewood Hospital and Medical Center</source>
  <brief_summary>
    <textblock>
      This study is intended to determine the efficacy of the Cooling Vest in reducing the&#xD;
      frequency and intensity of hot flashes and night sweats in men undergoing chemotherapy&#xD;
      treatment for prostate cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Cooling Vest is a vest manufactured by Nanohealth, Inc. It is a cool therapy device&#xD;
      intended to provide moderate, controlled cooling (approximately 15C/59F) by absorbing heat.&#xD;
      The material in the vest is safe, non-toxic, and eco-friendly.&#xD;
&#xD;
      This study attempts to collect data on the effects of the Cooling Vest in men with hot&#xD;
      flashes and night sweats due to the side effects of chemotherapy. Participants will use the&#xD;
      vest for 4 weeks and questionnaires will be used to determine effect.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">November 2017</completion_date>
  <primary_completion_date type="Actual">November 2017</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in number of daily hot flashes</measure>
    <time_frame>4 weeks</time_frame>
    <description>diary will be used to record the number of daily hot flashes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in the intensity of daily hot flashes</measure>
    <time_frame>4 weeks</time_frame>
    <description>diary will be used to record the severity of daily hot flashes</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Hot Flashes</condition>
  <arm_group>
    <arm_group_label>Cooling Vest</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During the four-week Treatment Period, participants should use the Cooling Vest two times per day (once in the morning for one hour and once in the evening for one hour.)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cooling Vest</intervention_name>
    <description>A cool therapy device intended to provide moderate, controlled cooling (approximately 15C/59F) by absorbing heat. The material in the vest is safe, non-toxic, and eco-friendly.</description>
    <arm_group_label>Cooling Vest</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males, who are at least 18 years old.&#xD;
&#xD;
          -  Self-reports having at least two (2) daily hot flashes associated with prostate cancer&#xD;
             chemotherapy-induced hot flashes and night sweats.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has another existing medical condition that would prevent study compliance.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric Margolis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Englewood Hospital and Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Urology Center Research Institute</name>
      <address>
        <city>Englewood</city>
        <state>New Jersey</state>
        <zip>07631</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>June 13, 2018</last_update_submitted>
  <last_update_submitted_qc>June 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 14, 2018</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>Hot Flashes</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/NCT03000322
org study id: E-16-680
nct id: NCT03000322
lead sponsor: 
This study is intended to determine the efficacy of the Cooling Vest in reducing the
      frequency and intensity of hot flashes and night sweats in men undergoing chemotherapy
      treatment for prostate cancer.
The Cooling Vest is a vest manufactured by Nanohealth, Inc. It is a cool therapy device
      intended to provide moderate, controlled cooling (approximately 15C/59F) by absorbing heat.
      The material in the vest is safe, non-toxic, and eco-friendly.

      This study attempts to collect data on the effects of the Cooling Vest in men with hot
      flashes and night sweats due to the side effects of chemotherapy. Participants will use the
      vest for 4 weeks and questionnaires will be used to determine effect.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: change in number of daily hot flashes
time frame: 4 weeks
description: diary will be used to record the number of daily hot flashes
measure: change in the intensity of daily hot flashes
time frame: 4 weeks
description: diary will be used to record the severity of daily hot flashes
arm group label: Cooling Vest
arm group type: Experimental
description: During the four-week Treatment Period, participants should use the Cooling Vest two times per day (once in the morning for one hour and once in the evening for one hour.)
intervention type: Device
intervention name: Cooling Vest
description: A cool therapy device intended to provide moderate, controlled cooling (approximately 15C/59F) by absorbing heat. The material in the vest is safe, non-toxic, and eco-friendly.
arm group label: Cooling Vest
criteria: 
gender: Male
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Eric Margolis, MD
role: Principal Investigator
affiliation: Englewood Hospital and Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hot Flashes