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/NCT06011525</url>
    </required_header>
    <id_info>
      <org_study_id>2023-A00769-36</org_study_id>
      <nct_id>NCT06011525</nct_id>
    </id_info>
    <brief_title>Prevention of Alopecia in Patients With Localised Breast Cancer</brief_title>
    <acronym>ICELAND</acronym>
    <official_title>Prevention of Alopecia in Patients With Localised Breast Cancer by Scalp cooLing vs Cooling Mask: a Randomised Controlled Trial With Medico-economic Evaluation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Francois Baclesse</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre Francois Baclesse</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 prevention of chemotherapy-induced alopecia (CIA) is still imperfectly managed in France.&#xD;
        Strengthening the evidence base on the benefits of strategies to prevent CIA, based on robust&#xD;
        methodologies, remains a prerequisite for better integration of appropriate supportive care&#xD;
        for patients receiving chemotherapy.&#xD;
  &#xD;
        This research should provide new knowledge on the benefits of scalp refrigeration during&#xD;
        anthracycline- and taxane-based chemotherapy in preventing ACI, for each of the 2&#xD;
        refrigeration techniques. In addition to effectiveness in preventing ACI, quality of life,&#xD;
        self-image and satisfaction with care will be assessed by patients during and after&#xD;
        chemotherapy. The medico-economic aspects will also be assessed for each of the two&#xD;
        refrigeration modalities. The results of the various proposed assessments will be used to&#xD;
        guide the choice between these two techniques for preventing ACI.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 3, 2023</start_date>
    <completion_date type="Anticipated">September 3, 2026</completion_date>
    <primary_completion_date type="Anticipated">September 3, 2025</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>Supportive Care</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Compare the grade of the patient alopecia.</measure>
      <time_frame>At 6 months after treatment start</time_frame>
      <description>The grade of patient alopecia will be be evaluated by NCI-CTCAE</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">196</enrollment>
    <condition>Chemotherapy-induced Alopecia</condition>
    <arm_group>
      <arm_group_label>standard cold-cap</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients will benefit from the prevention of chemo-induced alopecia using the standard cold cap device throughout the course of anthracycline- and taxane-based chemotherapy.&#xD;
  This device will be supplemented by a compression bandage to add to the vasoconstriction action of the cold, the compression of the bandage on the scalp and thus optimise the effectiveness of the device.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>scalp-cooling technique</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will benefit from the prevention of chemo-induced alopecia using the standard cold cap device throughout the course of anthracycline- and taxane-based chemotherapy.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>standard cold cap</intervention_name>
      <description>Standard cold-cap applied throughout anthracycline- and taxane-based chemotherapy treatment.&#xD;
  This device will be supplemented by a compressive bandage in order to add to the vasoconstriction action of the cold, the compression of the bandage on the scalp and thus optimise the efficacy of the device.</description>
      <arm_group_label>standard cold-cap</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>scalp-cooling technique</intervention_name>
      <description>Scalp-cooling technique applied throughout anthracycline- and taxane-based chemotherapy treatment</description>
      <arm_group_label>scalp-cooling technique</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age &gt;18&#xD;
  &#xD;
            -  Female&#xD;
  &#xD;
            -  Histologically proven diagnosis of localised, non-metastatic breast cancer&#xD;
  &#xD;
            -  Indication for neo-adjuvant or adjuvant anthracycline and taxane chemotherapy (3 EC100&#xD;
               followed by 3 Docetaxel or 3 EC100 plus 12 Paclitaxel); HER-positive status is not a&#xD;
               non-inclusion criterion.&#xD;
  &#xD;
            -  Patient willing to be photographed to assess IFA&#xD;
  &#xD;
            -  Fluency in French&#xD;
  &#xD;
            -  Patient affiliated to a social security scheme&#xD;
  &#xD;
            -  Signature of informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of neck pain&#xD;
  &#xD;
            -  Pre-existing alopecia&#xD;
  &#xD;
            -  Participation in another trial&#xD;
  &#xD;
            -  Dermatosis of the scalp&#xD;
  &#xD;
            -  Contraindication to scalp cooling&#xD;
  &#xD;
            -  History of migraines, stroke or hyperthyroidism&#xD;
  &#xD;
            -  History of scalp metastases&#xD;
  &#xD;
            -  Sensitivity to cold, cold agglutinin disease, cryoglobulinaemia, cryofibrinogenaemia&#xD;
               or post-traumatic cold dystrophy.&#xD;
  &#xD;
            -  Malignant haemopathies&#xD;
  &#xD;
            -  History of chemotherapy treatment&#xD;
  &#xD;
            -  Indication for cerebral irradiation&#xD;
  &#xD;
            -  Pregnant or breast-feeding patient&#xD;
  &#xD;
            -  Raynaud's syndrome&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Months</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Rose-Marie CHARLES</last_name>
      <phone>+33231458648</phone>
      <email>rm.charles@baclesse.unicancer.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>François GERNIER</last_name>
      <email>f.gernier@baclesse.unicancer.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>centre François Baclesse</name>
        <address>
          <city>Caen</city>
          <zip>14000</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Rose-Marie CHARLES</last_name>
        <email>rm.charles@baclesse.unicancer.fr</email>
      </contact>
      <contact_backup>
        <last_name>François GERNIER</last_name>
        <email>f.gernier@baclesse.unicancer.fr</email>
      </contact_backup>
      <investigator>
        <last_name>Rose-Marie CHARLES</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Centre Oscar Lambret</name>
        <address>
          <city>Lille</city>
          <country>France</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Nathalie DEREUMAUX</last_name>
        <email>N-Dereumaux@o-lambret.fr</email>
      </contact>
      <investigator>
        <last_name>Nathalie DEREUMAUX</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>alopecia</keyword>
    <keyword>chemotherapy-induced</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Alopecia</mesh_term>
      <mesh_term>Alopecia Areata</mesh_term>
    </condition_browse>
    <!-- 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/NCT06011525
  org study id: 2023-A00769-36
  nct id: NCT06011525
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The prevention of chemotherapy-induced alopecia (CIA) is still imperfectly managed in France.
        Strengthening the evidence base on the benefits of strategies to prevent CIA, based on robust
        methodologies, remains a prerequisite for better integration of appropriate supportive care
        for patients receiving chemotherapy.
  
        This research should provide new knowledge on the benefits of scalp refrigeration during
        anthracycline- and taxane-based chemotherapy in preventing ACI, for each of the 2
        refrigeration techniques. In addition to effectiveness in preventing ACI, quality of life,
        self-image and satisfaction with care will be assessed by patients during and after
        chemotherapy. The medico-economic aspects will also be assessed for each of the two
        refrigeration modalities. The results of the various proposed assessments will be used to
        guide the choice between these two techniques for preventing ACI.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Participant)
  measure: Compare the grade of the patient alopecia.
  time frame: At 6 months after treatment start
  description: The grade of patient alopecia will be be evaluated by NCI-CTCAE
  arm group label: standard cold-cap
  arm group type: Active Comparator
  description: Patients will benefit from the prevention of chemo-induced alopecia using the standard cold cap device throughout the course of anthracycline- and taxane-based chemotherapy.
  This device will be supplemented by a compression bandage to add to the vasoconstriction action of the cold, the compression of the bandage on the scalp and thus optimise the effectiveness of the device.
  arm group label: scalp-cooling technique
  arm group type: Experimental
  description: Patients will benefit from the prevention of chemo-induced alopecia using the standard cold cap device throughout the course of anthracycline- and taxane-based chemotherapy.
  intervention type: Other
  intervention name: standard cold cap
  description: Standard cold-cap applied throughout anthracycline- and taxane-based chemotherapy treatment.
  This device will be supplemented by a compressive bandage in order to add to the vasoconstriction action of the cold, the compression of the bandage on the scalp and thus optimise the efficacy of the device.
  arm group label: standard cold-cap
  intervention type: Other
  intervention name: scalp-cooling technique
  description: Scalp-cooling technique applied throughout anthracycline- and taxane-based chemotherapy treatment
  arm group label: scalp-cooling technique
  criteria: 
  gender: Female
  minimum age: 18 Months
  maximum age: N/A
  healthy volunteers: No
  last name: Rose-Marie CHARLES
  phone: +33231458648
  email: rm.charles@baclesse.unicancer.fr
  last name: François GERNIER
  email: f.gernier@baclesse.unicancer.fr
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  facility: 
  status: Not yet recruiting
  contact: 
  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Alopecia
  mesh term: Alopecia Areata