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/NCT06039137</url>
    </required_header>
    <id_info>
      <org_study_id>METC 2022-0007</org_study_id>
      <nct_id>NCT06039137</nct_id>
    </id_info>
    <brief_title>The Effect of Switching the H1-antagonist Clemastine to Cetirizine in Premedication Regimens During Paclitaxel Treatment</brief_title>
    <acronym>H1-Switch</acronym>
    <official_title>The Effect of Switching the H1-antagonist Clemastine to Cetirizine in Premedication Regimens During Paclitaxel Treatment: 'The H1-SWITCH Study'</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Erasmus Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Erasmus Medical Center</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        In this study the effect of substituting clemastine IV to cetirizine PO on the occurence of&#xD;
        hypersensitivity reactions during paclitaxel chemotherapy will be investigated.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a single arm before-after study with a historic control cohort to evaluate the effect&#xD;
        of a policy change (i.e. substitution of clemastine IV for cetirizine PO) regarding the&#xD;
        premedication scheme on the incidence of HSR during paclitaxel based chemotherapy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">June 1, 2022</start_date>
    <completion_date type="Anticipated">October 31, 2023</completion_date>
    <primary_completion_date type="Actual">April 27, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Clinically relevant hypersensitivity reactions</measure>
      <time_frame>During the first six cycles of paclitaxel treatment (the length of one cycle of paclitaxel treatment varies but is typically 7-21 days, depending on standard of care protocol).</time_frame>
      <description>Hypersensitivity reactions grade 3 or higher according to CTCAE v4.03</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Hypersensitivity reactions</measure>
      <time_frame>During the first six cycles of paclitaxel treatment (the length of one cycle of paclitaxel treatment varies but is typically 7-21 days, depending on standard of care protocol).</time_frame>
      <description>Hypersensitivity reactions any grade according to CTCAE v4.03</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The difference in the number of paclitaxel dosages until first HSR occurrence</measure>
      <time_frame>During the first six cycles of paclitaxel treatment (the length of one cycle of paclitaxel treatment varies but is typically 7-21 days, depending on standard of care protocol).</time_frame>
      <description>The difference in the number of paclitaxel dosages until first HSR occurrence between the arms will be described.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The difference in the number of paclitaxel dosages until first HSR occurrence</measure>
      <time_frame>During the first six cycles of paclitaxel treatment (the length of one cycle of paclitaxel treatment varies but is typically 7-21 days, depending on standard of care protocol).</time_frame>
      <description>The difference in the number of paclitaxel dosages until first HSR occurrence</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">395</enrollment>
    <condition>Solid Tumor</condition>
    <arm_group>
      <arm_group_label>Clemastine group</arm_group_label>
      <description>Subjects receiving standard of care treatment with paclitaxel either as monotherapy or as part of a combination for any standard of care oncologic indication. Subjects received a paclitaxel premedication regimen containing dexamethasone 10 mg IV and clemastine 2 mg IV</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cetirizine group</arm_group_label>
      <description>Subjects receiving standard of care treatment with paclitaxel either as monotherapy or as part of a combination for any standard of care oncologic indication. Subjects received a paclitaxel premedication regimen containing dexamethasone 10 mg IV and cetirizine 10 mg PO</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Cetirizine</intervention_name>
      <description>Subjects were treated with a paclitaxel premedication regimen which contained oral cetirizine instead of intravenous clemastine</description>
      <arm_group_label>Cetirizine group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with solid tumors for whom paclitaxel-based chemotherapy is considered standard&#xD;
          treatment will be eligible for this trial. Patients will be included from the outpatient&#xD;
          population of the Erasmus MC in Rotterdam.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Age ≥ 18 years; Planned treatment with regular paclitaxel-based chemotherapy for any&#xD;
          indication and with any dose;&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Prior treatment with a paclitaxel-based regimen; Inability to orally ingest cetirizine;&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Roelof van Leeuwen, PharmD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Erasmus Medical Center</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Erasmus University Medical Center</name>
        <address>
          <city>Rotterdam</city>
          <state>Zuid-Holland</state>
          <zip>3015 GD</zip>
          <country>Netherlands</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Erasmus Medical Center</investigator_affiliation>
      <investigator_full_name>Roelof W.F. van Leeuwen</investigator_full_name>
      <investigator_title>Principal investigator</investigator_title>
    </responsible_party>
    <keyword>Paclitaxel</keyword>
    <keyword>Allergic reaction</keyword>
    <keyword>HSR</keyword>
    <keyword>Chemotherapy</keyword>
    <keyword>Premedication</keyword>
    <keyword>Cancer</keyword>
    <keyword>Oncology</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cetirizine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06039137
  org study id: METC 2022-0007
  nct id: NCT06039137
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  In this study the effect of substituting clemastine IV to cetirizine PO on the occurence of
        hypersensitivity reactions during paclitaxel chemotherapy will be investigated.
  This is a single arm before-after study with a historic control cohort to evaluate the effect
        of a policy change (i.e. substitution of clemastine IV for cetirizine PO) regarding the
        premedication scheme on the incidence of HSR during paclitaxel based chemotherapy.
  observational model: Cohort
  time perspective: Other
  measure: Clinically relevant hypersensitivity reactions
  time frame: During the first six cycles of paclitaxel treatment (the length of one cycle of paclitaxel treatment varies but is typically 7-21 days, depending on standard of care protocol).
  description: Hypersensitivity reactions grade 3 or higher according to CTCAE v4.03
  measure: Hypersensitivity reactions
  time frame: During the first six cycles of paclitaxel treatment (the length of one cycle of paclitaxel treatment varies but is typically 7-21 days, depending on standard of care protocol).
  description: Hypersensitivity reactions any grade according to CTCAE v4.03
  measure: The difference in the number of paclitaxel dosages until first HSR occurrence
  time frame: During the first six cycles of paclitaxel treatment (the length of one cycle of paclitaxel treatment varies but is typically 7-21 days, depending on standard of care protocol).
  description: The difference in the number of paclitaxel dosages until first HSR occurrence between the arms will be described.
  measure: The difference in the number of paclitaxel dosages until first HSR occurrence
  time frame: During the first six cycles of paclitaxel treatment (the length of one cycle of paclitaxel treatment varies but is typically 7-21 days, depending on standard of care protocol).
  description: The difference in the number of paclitaxel dosages until first HSR occurrence
  arm group label: Clemastine group
  description: Subjects receiving standard of care treatment with paclitaxel either as monotherapy or as part of a combination for any standard of care oncologic indication. Subjects received a paclitaxel premedication regimen containing dexamethasone 10 mg IV and clemastine 2 mg IV
  arm group label: Cetirizine group
  description: Subjects receiving standard of care treatment with paclitaxel either as monotherapy or as part of a combination for any standard of care oncologic indication. Subjects received a paclitaxel premedication regimen containing dexamethasone 10 mg IV and cetirizine 10 mg PO
  intervention type: Drug
  intervention name: Cetirizine
  description: Subjects were treated with a paclitaxel premedication regimen which contained oral cetirizine instead of intravenous clemastine
  arm group label: Cetirizine group
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Roelof van Leeuwen, PharmD, PhD
  role: Principal Investigator
  affiliation: Erasmus Medical Center
  facility: 
  country: Netherlands
  responsible party type: Principal Investigator
  investigator affiliation: Erasmus Medical Center
  investigator full name: Roelof W.F. van Leeuwen
  investigator title: Principal investigator
  mesh term: Cetirizine
  sharing ipd: Undecided