<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/NCT01661413</url>
  </required_header>
  <id_info>
    <org_study_id>1000030743</org_study_id>
    <nct_id>NCT01661413</nct_id>
  </id_info>
  <brief_title>Nausea and Vomiting in Children Receiving Chemotherapeautic Monotherapy</brief_title>
  <official_title>Chemotherapy-induced Nausea and Vomiting in Children Receiving Intrathecal Methotrexate With/Without Vincristine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hospital for Sick Children</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Hospital for Sick Children</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chemotherapy induced nausea is a common side effect for children undergoing chemotherapy.&#xD;
      Furthermore, chemotherapy-induced vomiting is a major factor limiting quality of life during&#xD;
      treatment reported by paediatric cancer survivors. Complete prevention of both nausea and&#xD;
      vomiting is the goal of anti-vomiting and nausea medications. It is important to understand&#xD;
      whether or not certain chemotherapeutic treatments are more or less likely to cause these&#xD;
      symptoms. Acute leukemia is the most common cancer diagnosed in children. Intrathecal&#xD;
      methotrexate is an important part of chemotherapy for the prevention and treatment of central&#xD;
      nervous system leukemia over the 2.5 to 3.5 years of the treatment program for leukemia. The&#xD;
      likelihood that intrathecal methotrexate administered as monotherapy will cause nausea and&#xD;
      vomiting has not yet been described in children. Knowledge of the likelihood that intrathecal&#xD;
      methotrexate will cause nausea and vomiting will therefore be important to optimize treatment&#xD;
      for these side-effects of chemotherapy. The primary aim of this prospective study is to&#xD;
      evaluate the potential of intrathecal methotrexate to cause nausea and vomiting in paediatric&#xD;
      cancer patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 7, 2012</start_date>
  <completion_date type="Actual">October 31, 2015</completion_date>
  <primary_completion_date type="Actual">October 31, 2015</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Acute Chemotherapy-Induced Nausea and Vomiting</measure>
    <time_frame>Over 24 hours after receiving intrathecal methotrexate on day 1</time_frame>
    <description>To describe the prevalence of acute phase CINV in these patients. Acute CINV is defined as nausea, vomiting or retching occurring within the first 24 hours following chemotherapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anticipatory Chemotherapy-Induced Nausea and Vomiting</measure>
    <time_frame>Baseline</time_frame>
    <description>To describe the prevalence of anticipatory nausea and vomiting in these patients. Anticipatorty nausea and vomiting begins prior to the administration of chemotherapy in patients who have previously received chemotherapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delayed Chemotherapy-Induced Nausea and Vomiting</measure>
    <time_frame>Over 168 hours (7 days) after receiving first treatment of intrathecal methotrexate</time_frame>
    <description>To describe the prevalence of delayed phase CINV in these patients. Delayed CINV develops after the initial 24 hours and might last up to 7 days.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">88</enrollment>
  <condition>Acute Leukemia</condition>
  <arm_group>
    <arm_group_label>Acute Leukemia</arm_group_label>
    <description>Children diagnosed with acute leukemia, undergoing chemotherapy. Patients with acute leukemia will receive intrathecal methotrexate on day 1 plus intravenous vincristine on day 1 plus oral steroid on days 1-5 plus their regularly scheduled and ongoing daily oral 6-mercaptopurine at the start of a maintenance therapy cycle.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Receiving intrathecal methotrexate in the context of maintenance therapy for acute&#xD;
        lymphoblastic leukemia and as dosed by age per protocol. Patients will also receive their&#xD;
        protocol driven maintenance chemotherapy which includes oral 6 mercaptopurine and may&#xD;
        include IV vincristine and an oral steroid pulse (prednisone or dexamethasone). Oral&#xD;
        methotrexate is typically held the weeks that patients receive intrathecal methotrexate&#xD;
        during maintenance therapy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  4 years old to 18 years of age (age range in which the PeNAT has been validated) [18]&#xD;
&#xD;
          -  English speaking (PeNAT has been validated only in English)&#xD;
&#xD;
          -  Cognitive ability of the child believed to be at least at a 4 year old level according&#xD;
             to parent or health care professional&#xD;
&#xD;
          -  Patients are past their first cycle of maintenance therapy to avoid interactions with&#xD;
             the intensive chemotherapy phase.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Receiving chemotherapy other than dictated by protocol for maintenance therapy within&#xD;
             24 hours prior to or 24 hours following receipt of intrathecal methotrexate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Angela Punnett, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hospital for Sick Children</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lee Dupuis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hospital for Sick Children</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Hospital for Sick Children</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <last_update_submitted>November 15, 2019</last_update_submitted>
  <last_update_submitted_qc>November 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hospital for Sick Children</investigator_affiliation>
    <investigator_full_name>Angela Punnett</investigator_full_name>
    <investigator_title>Staff Physician</investigator_title>
  </responsible_party>
  <keyword>Acute Leukemia</keyword>
  <keyword>Pediatrics</keyword>
  <keyword>Intrathecal methotrexate</keyword>
  <keyword>Chemotherapy</keyword>
  <keyword>Nausea</keyword>
  <keyword>Vomiting</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nausea</mesh_term>
    <mesh_term>Vomiting</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/NCT01661413
org study id: 1000030743
nct id: NCT01661413
lead sponsor: 
has dmc: No
Chemotherapy induced nausea is a common side effect for children undergoing chemotherapy.
      Furthermore, chemotherapy-induced vomiting is a major factor limiting quality of life during
      treatment reported by paediatric cancer survivors. Complete prevention of both nausea and
      vomiting is the goal of anti-vomiting and nausea medications. It is important to understand
      whether or not certain chemotherapeutic treatments are more or less likely to cause these
      symptoms. Acute leukemia is the most common cancer diagnosed in children. Intrathecal
      methotrexate is an important part of chemotherapy for the prevention and treatment of central
      nervous system leukemia over the 2.5 to 3.5 years of the treatment program for leukemia. The
      likelihood that intrathecal methotrexate administered as monotherapy will cause nausea and
      vomiting has not yet been described in children. Knowledge of the likelihood that intrathecal
      methotrexate will cause nausea and vomiting will therefore be important to optimize treatment
      for these side-effects of chemotherapy. The primary aim of this prospective study is to
      evaluate the potential of intrathecal methotrexate to cause nausea and vomiting in paediatric
      cancer patients.
observational model: Cohort
time perspective: Prospective
measure: Acute Chemotherapy-Induced Nausea and Vomiting
time frame: Over 24 hours after receiving intrathecal methotrexate on day 1
description: To describe the prevalence of acute phase CINV in these patients. Acute CINV is defined as nausea, vomiting or retching occurring within the first 24 hours following chemotherapy.
measure: Anticipatory Chemotherapy-Induced Nausea and Vomiting
time frame: Baseline
description: To describe the prevalence of anticipatory nausea and vomiting in these patients. Anticipatorty nausea and vomiting begins prior to the administration of chemotherapy in patients who have previously received chemotherapy.
measure: Delayed Chemotherapy-Induced Nausea and Vomiting
time frame: Over 168 hours (7 days) after receiving first treatment of intrathecal methotrexate
description: To describe the prevalence of delayed phase CINV in these patients. Delayed CINV develops after the initial 24 hours and might last up to 7 days.
arm group label: Acute Leukemia
description: Children diagnosed with acute leukemia, undergoing chemotherapy. Patients with acute leukemia will receive intrathecal methotrexate on day 1 plus intravenous vincristine on day 1 plus oral steroid on days 1-5 plus their regularly scheduled and ongoing daily oral 6-mercaptopurine at the start of a maintenance therapy cycle.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 4 Years
maximum age: 18 Years
healthy volunteers: No
last name: Angela Punnett, MD
role: Principal Investigator
affiliation: The Hospital for Sick Children
last name: Lee Dupuis, MD
role: Principal Investigator
affiliation: The Hospital for Sick Children
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: The Hospital for Sick Children
investigator full name: Angela Punnett
investigator title: Staff Physician
mesh term: Nausea
mesh term: Vomiting