<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/NCT03266185</url>
  </required_header>
  <id_info>
    <org_study_id>NL61964.058.17</org_study_id>
    <nct_id>NCT03266185</nct_id>
  </id_info>
  <brief_title>Shorter Scalp Cooling Time in Paclitaxel</brief_title>
  <acronym>COP</acronym>
  <official_title>Prospective, Multi-centre Trial to Evaluate Effectiveness of 45-min and 20-min Post-infusion Cooling Time for Patients Treated With Scalp Cooling to Prevent Paclitaxel-induced Alopecia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Leiden University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Leiden University Medical Center</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>
      Chemotherapy-induced alopecia (CIA) is one of the most distressing side effects for patients.&#xD;
      Scalp cooling can prevent or minimise CIA in approximately half of all patients, depending on&#xD;
      many factors, e.g. type and dosage of chemotherapy. High rates of success are seen in&#xD;
      patients treated with taxanes, up to 80-90%. Previous research has shown comparable results&#xD;
      of scalp cooling in docetaxel-treated patients when shortening the post-infusion cooling time&#xD;
      (PICT) from the initial standard of 90 minutes to 45- and 20 minutes. A shorter PICT is an&#xD;
      advantage for both the patient, who can spend less time in the hospital, as well for the&#xD;
      logistics at oncological departments. Paclitaxel and docetaxel are both classical taxanes,&#xD;
      that share similar mechanisms of action and have comparable plasma terminal half-life times,&#xD;
      therefore it seems plausible that the PICT can be shortened for paclitaxel-treated patients&#xD;
      as well.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 20, 2017</start_date>
  <completion_date type="Actual">August 28, 2020</completion_date>
  <primary_completion_date type="Actual">August 28, 2020</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To determine the efficacy of scalp cooling in patients treated with paclitaxel-containing chemotherapy with a 45- and 20-minutes post-infusion cooling time, defined by the patient's self-determined need to wear a wig or other head covering</measure>
    <time_frame>up to 52 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>To determine the degree of chemotherapy-induced alopecia (CIA), assessed with the DEAN scale for assessment of hair loss</measure>
    <time_frame>up to 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine the grade of chemotherapy-induced alopecia (CIA), according to NCI-CTCAEv4.03</measure>
    <time_frame>up to 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine the tolerance of scalp cooling, assessed by a (self-adapted) visual analogue scale (VAS)</measure>
    <time_frame>up to 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine the added value of scalp cooling for weekly paclitaxel; what is the incidence of severe alopecia with and without scalp cooling</measure>
    <time_frame>up to 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessing the amount of distress experienced by CIA in patients, assessed with the chemotherapy-induced alopecia distress scale (CADS)</measure>
    <time_frame>up to 24 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">91</enrollment>
  <condition>Neoplasm Malignant</condition>
  <condition>Breast Cancer</condition>
  <condition>Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>45-minutes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>45-minutes post-infusion cooling time</description>
  </arm_group>
  <arm_group>
    <arm_group_label>20-minutes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20-minutes post-infusion cooling time</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No scalp cooling</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients who decline scalp cooling will be included as a control group to determine the incidence of paclitaxel-induced alopecia</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Shorter PICT</intervention_name>
    <description>Shorter post-infusion cooling time</description>
    <arm_group_label>20-minutes</arm_group_label>
    <arm_group_label>45-minutes</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients receiving weekly-administered paclitaxel-containing chemotherapy (minimal 3&#xD;
             planned administrations) in a dose of 80-90 mg/m2 Paclitaxel monotherapy, Paclitaxel&#xD;
             in combination with carboplatin, Paclitaxel in combination with monoclonal antibodies:&#xD;
             Bevacizumab or Trastuzumab&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  WHO performance status 0-2&#xD;
&#xD;
          -  Survival expectation must be &gt; 3 months&#xD;
&#xD;
          -  Written informed consent according to the local Ethics Committee requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Treatment with paclitaxel in sequential schemes with other alopecia inducing agents&#xD;
             such as paclitaxel monotherapy after adriamycin, cyclophosphamide (AC) or paclitaxel&#xD;
             monotherapy after 5-fluouracil, epirubicin, cyclophosphamide (FEC) treatment&#xD;
&#xD;
          -  Alopecia before the start of the study&#xD;
&#xD;
          -  Rare cold-related disorders: Cold sensitivity, Cold agglutinin disease,&#xD;
             Cryoglobulinaemia, Cryofibrinogenaemia, Cold posttraumatic dystrophy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>LUMC</name>
      <address>
        <city>Leiden</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>August 26, 2017</study_first_submitted>
  <study_first_submitted_qc>August 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>March 30, 2021</last_update_submitted>
  <last_update_submitted_qc>March 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Leiden University Medical Center</investigator_affiliation>
    <investigator_full_name>J.R. Kroep</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>paclitaxel-containing chemotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</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/NCT03266185
org study id: NL61964.058.17
nct id: NCT03266185
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Chemotherapy-induced alopecia (CIA) is one of the most distressing side effects for patients.
      Scalp cooling can prevent or minimise CIA in approximately half of all patients, depending on
      many factors, e.g. type and dosage of chemotherapy. High rates of success are seen in
      patients treated with taxanes, up to 80-90%. Previous research has shown comparable results
      of scalp cooling in docetaxel-treated patients when shortening the post-infusion cooling time
      (PICT) from the initial standard of 90 minutes to 45- and 20 minutes. A shorter PICT is an
      advantage for both the patient, who can spend less time in the hospital, as well for the
      logistics at oncological departments. Paclitaxel and docetaxel are both classical taxanes,
      that share similar mechanisms of action and have comparable plasma terminal half-life times,
      therefore it seems plausible that the PICT can be shortened for paclitaxel-treated patients
      as well.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: To determine the efficacy of scalp cooling in patients treated with paclitaxel-containing chemotherapy with a 45- and 20-minutes post-infusion cooling time, defined by the patient's self-determined need to wear a wig or other head covering
time frame: up to 52 weeks
measure: To determine the degree of chemotherapy-induced alopecia (CIA), assessed with the DEAN scale for assessment of hair loss
time frame: up to 52 weeks
measure: To determine the grade of chemotherapy-induced alopecia (CIA), according to NCI-CTCAEv4.03
time frame: up to 52 weeks
measure: To determine the tolerance of scalp cooling, assessed by a (self-adapted) visual analogue scale (VAS)
time frame: up to 52 weeks
measure: To determine the added value of scalp cooling for weekly paclitaxel; what is the incidence of severe alopecia with and without scalp cooling
time frame: up to 52 weeks
measure: Assessing the amount of distress experienced by CIA in patients, assessed with the chemotherapy-induced alopecia distress scale (CADS)
time frame: up to 24 weeks
arm group label: 45-minutes
arm group type: Experimental
description: 45-minutes post-infusion cooling time
arm group label: 20-minutes
arm group type: Experimental
description: 20-minutes post-infusion cooling time
arm group label: No scalp cooling
arm group type: No Intervention
description: Patients who decline scalp cooling will be included as a control group to determine the incidence of paclitaxel-induced alopecia
intervention type: Other
intervention name: Shorter PICT
description: Shorter post-infusion cooling time
arm group label: 20-minutes
arm group label: 45-minutes
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Leiden University Medical Center
investigator full name: J.R. Kroep
investigator title: MD, PhD
mesh term: Neoplasms
sharing ipd: No