<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/NCT01683552</url>
  </required_header>
  <id_info>
    <org_study_id>Aprepitant-Itch</org_study_id>
    <nct_id>NCT01683552</nct_id>
  </id_info>
  <brief_title>Aprepitant in the Management of Biological Therapies-related Severe Pruritus</brief_title>
  <acronym>AprepIt</acronym>
  <official_title>Aprepitant in the Management of Biological Therapies-related Severe Pruritus: a Pilot Study in 45 Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Campus Bio-Medico University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Campus Bio-Medico University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Itch is a common side effect of anti-epidermal growth factor receptor antibodies and tyrosine&#xD;
      kinase inhibitors. Investigators designed a pilot single-center phase II study evaluating the&#xD;
      effects of Aprepitant, a neurokinin receptor inhibitor, in managing biological&#xD;
      therapy-induced pruritus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigators enroll patients affected by solid tumors which present itch refractory to&#xD;
      standard treatment (&quot;refractory group&quot;) and patients who did not receive any treatment for&#xD;
      pruritus (&quot;naïve group&quot;). The intensity of itch will be evaluated with Visual Analogue Scale&#xD;
      (VAS) score. In the refractory group Aprepitant (125 mg on day 1; 80 mg on day 3; 80 mg on&#xD;
      day 5) will be administered after at least 1 week of standard systemic treatment. In the&#xD;
      naïve group, Aprepitant will be administered after the first onset of severe pruritus. The&#xD;
      primary end point is to evaluate the effect of aprepitant in managing pruritus both in naive&#xD;
      and refractory group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2010</start_date>
  <completion_date type="Actual">November 2011</completion_date>
  <primary_completion_date type="Actual">November 2011</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-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>Severity of ITCH</measure>
    <time_frame>once before aprepitant administration; 7 days after the first dose of aprepitant, and once a week until the end of biological therapy</time_frame>
    <description>Patients is asked to grade the intensity of their itch on the VAS, with the strongest possible itch marked at the right end of the line (10) and no itch marked at the left end (0). The VAS score is registered in a diary supplied 7 days before starting the study and every week throughout the study period.&#xD;
Pruritus intensity is evaluated by VAS score once before Aprepitant administration, once 7 days after the first dose of Aprepitant and once a week until the end of biological therapy or the pruritus recurrence. Response (evaluated one week after the first Aprepitant dose) is defined as &gt; 50% reduction of pruritus intensity compared to the baseline value.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>ITCH</condition>
  <arm_group>
    <arm_group_label>Aprepitant</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Aprepitant is administered in patients ,affected by solid tumors treated with biological therapy, who did not receive any treatment for severe pruritus</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aprepitant after anti-itch standard therapy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Aprepitant will be administered in patient affected by severe itch resistant to standard treatment (steroids and/or antihistamines) administered for at least one week</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aprepitant</intervention_name>
    <description>125 mg on day 1; 80 mg on day 3; 80 mg on day 5</description>
    <arm_group_label>Aprepitant</arm_group_label>
    <arm_group_label>Aprepitant after anti-itch standard therapy</arm_group_label>
    <other_name>Emend</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisone</intervention_name>
    <description>In the refractory group (VAS score ≥7), Aprepitant (125 mg on day 1; 80 mg on day 3; 80 mg on day 5) is administered after at least one week of standard systemic treatment (prednisone 25 mg/die and/or fexofenadine 180 mg/die),</description>
    <arm_group_label>Aprepitant after anti-itch standard therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fexofenadine</intervention_name>
    <description>In the refractory group (VAS score ≥7), Aprepitant (125 mg on day 1; 80 mg on day 3; 80 mg on day 5) is administered after at least one week of standard systemic treatment (prednisone 25 mg/die and/or fexofenadine 180 mg/die)</description>
    <arm_group_label>Aprepitant after anti-itch standard therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  histologically confirmed diagnosis of solid tumor&#xD;
&#xD;
          -  treatment with anti-EGFR antibodies or TKIs&#xD;
&#xD;
          -  first onset of severe pruritus during treatment (≥7 on Visual Analogue Scale (VAS)&#xD;
             score)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  oral treatment with antimycotics during 4 weeks preceding enrolment&#xD;
&#xD;
          -  topical treatment during the previous 2 weeks&#xD;
&#xD;
          -  concomitant,chronic renal or hepatic insufficiency , skin infection or dermatitis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniele Santini, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Campus Bio-Medico of Rome University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Campus Bio-Medico of Rome University</name>
      <address>
        <city>Roma</city>
        <zip>00128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <last_update_submitted>September 11, 2012</last_update_submitted>
  <last_update_submitted_qc>September 11, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Campus Bio-Medico University</investigator_affiliation>
    <investigator_full_name>Daniele Santini</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>ITCH</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pruritus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fexofenadine</mesh_term>
    <mesh_term>Prednisone</mesh_term>
    <mesh_term>Aprepitant</mesh_term>
  </intervention_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/NCT01683552
org study id: Aprepitant-Itch
nct id: NCT01683552
lead sponsor: 
has dmc: No
Itch is a common side effect of anti-epidermal growth factor receptor antibodies and tyrosine
      kinase inhibitors. Investigators designed a pilot single-center phase II study evaluating the
      effects of Aprepitant, a neurokinin receptor inhibitor, in managing biological
      therapy-induced pruritus.
Investigators enroll patients affected by solid tumors which present itch refractory to
      standard treatment ("refractory group") and patients who did not receive any treatment for
      pruritus ("naïve group"). The intensity of itch will be evaluated with Visual Analogue Scale
      (VAS) score. In the refractory group Aprepitant (125 mg on day 1; 80 mg on day 3; 80 mg on
      day 5) will be administered after at least 1 week of standard systemic treatment. In the
      naïve group, Aprepitant will be administered after the first onset of severe pruritus. The
      primary end point is to evaluate the effect of aprepitant in managing pruritus both in naive
      and refractory group.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Severity of ITCH
time frame: once before aprepitant administration; 7 days after the first dose of aprepitant, and once a week until the end of biological therapy
description: Patients is asked to grade the intensity of their itch on the VAS, with the strongest possible itch marked at the right end of the line (10) and no itch marked at the left end (0). The VAS score is registered in a diary supplied 7 days before starting the study and every week throughout the study period.
Pruritus intensity is evaluated by VAS score once before Aprepitant administration, once 7 days after the first dose of Aprepitant and once a week until the end of biological therapy or the pruritus recurrence. Response (evaluated one week after the first Aprepitant dose) is defined as > 50% reduction of pruritus intensity compared to the baseline value.
arm group label: Aprepitant
arm group type: Other
description: Aprepitant is administered in patients ,affected by solid tumors treated with biological therapy, who did not receive any treatment for severe pruritus
arm group label: Aprepitant after anti-itch standard therapy
arm group type: Other
description: Aprepitant will be administered in patient affected by severe itch resistant to standard treatment (steroids and/or antihistamines) administered for at least one week
intervention type: Drug
intervention name: Aprepitant
description: 125 mg on day 1; 80 mg on day 3; 80 mg on day 5
arm group label: Aprepitant
arm group label: Aprepitant after anti-itch standard therapy
other name: Emend
intervention type: Drug
intervention name: Prednisone
description: In the refractory group (VAS score ≥7), Aprepitant (125 mg on day 1; 80 mg on day 3; 80 mg on day 5) is administered after at least one week of standard systemic treatment (prednisone 25 mg/die and/or fexofenadine 180 mg/die),
arm group label: Aprepitant after anti-itch standard therapy
intervention type: Drug
intervention name: Fexofenadine
description: In the refractory group (VAS score ≥7), Aprepitant (125 mg on day 1; 80 mg on day 3; 80 mg on day 5) is administered after at least one week of standard systemic treatment (prednisone 25 mg/die and/or fexofenadine 180 mg/die)
arm group label: Aprepitant after anti-itch standard therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Daniele Santini, MD, PhD
role: Principal Investigator
affiliation: Campus Bio-Medico of Rome University
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Campus Bio-Medico University
investigator full name: Daniele Santini
investigator title: MD, PhD
mesh term: Pruritus
mesh term: Fexofenadine
mesh term: Prednisone
mesh term: Aprepitant