<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/NCT04479514</url>
  </required_header>
  <id_info>
    <org_study_id>19-579</org_study_id>
    <nct_id>NCT04479514</nct_id>
  </id_info>
  <brief_title>Preventative Skin Care for Children Undergoing Targeted CNS Tumor Therapy</brief_title>
  <official_title>Preventative Skin Care for Children Undergoing Targeted CNS Tumor Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dana-Farber Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dana-Farber Cancer Institute</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>
      This research study is examining a preventive skin care regimen for children diagnosed with a&#xD;
      brain tumor and receiving anti-cancer therapy with a MEK, Pan-RAF, or BRAF inhibitor.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective, single-arm phase 2 clinical trial is looking at whether gentle skin care,&#xD;
      sun protection and dilute bleach baths might decrease the chances or the severity of skin&#xD;
      changes that occur during treatment for brain tumors.&#xD;
&#xD;
      The research study procedures include screening for eligibility and study treatment including&#xD;
      evaluations and follow up visits.&#xD;
&#xD;
      Participants will receive a study treatment regimen that involves a daily sun protection,&#xD;
      daily gentle skin care and every-other-day dilute bleach baths for the duration of the study.&#xD;
&#xD;
      Participants enrolled in this study, will be in this research study during the course of&#xD;
      their anti-cancer treatment and receive skin examinations and complete a survey about their&#xD;
      skin condition at the initial visit when anti-cancer treatment is started, at six weeks after&#xD;
      the start of anti-cancer treatment, and at twelve weeks after the start of anti-cancer&#xD;
      treatment.&#xD;
&#xD;
      Participants will be followed for twelve weeks.&#xD;
&#xD;
      It is expected that about 20 people will take part in this research study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of Cutaneous Reaction</measure>
    <time_frame>12 weeks</time_frame>
    <description>Proportion (percentage) of patients with one or more cutaneous reaction to targeted BRAF, MEK, or Pan-RAF inhibitor therapy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Cutaneous Reaction Severity</measure>
    <time_frame>12 weeks</time_frame>
    <description>Measured by the Common Terminology Criteria for Adverse Events (CTCAE)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Xerosis Severity</measure>
    <time_frame>12 weeks</time_frame>
    <description>Measured by the Overall Dry Skin Score (ODS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hand foot syndrome Severity</measure>
    <time_frame>12 weeks</time_frame>
    <description>Measured by the Hand-Foot Skin Reaction and Quality of Life Score (HFS-14)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pediatric Quality of life</measure>
    <time_frame>12 weeks</time_frame>
    <description>Pediatric Quality of Life Inventory (PedsQL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Children's Dermatology Quality of life</measure>
    <time_frame>12 weeks</time_frame>
    <description>Children's Dermatology Life Quality Index (CDLQI)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Pediatric Cancer</condition>
  <condition>CNS Tumor, Childhood</condition>
  <condition>Skin Inflammation</condition>
  <arm_group>
    <arm_group_label>Preventative Skin Care Routine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will perform a preventative skin care routine that includes daily sun protection, daily gentle skin care and every-other-day dilute bleach baths for the duration of the study.&#xD;
Participants will receive skin examinations and complete a survey about their skin condition at the initial visit when anti-cancer treatment is started, at six weeks after the start of treatment, and at twelve weeks after the start of treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Warm Baths or Showers</intervention_name>
    <description>Daily warm baths or showers</description>
    <arm_group_label>Preventative Skin Care Routine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Moisturizer</intervention_name>
    <description>moisturizers applied daily immediately after bathing</description>
    <arm_group_label>Preventative Skin Care Routine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SPF 30 or Higher Suncreen</intervention_name>
    <description>Mineral based sunscreen of SPF 30 or higher applied on a daily basis on all sun exposed areas.</description>
    <arm_group_label>Preventative Skin Care Routine</arm_group_label>
    <other_name>i.e. Neutrogena, Aveeno, Cerave, Blue Lizard</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sun Protective Clothing</intervention_name>
    <description>Sun protective clothing worn when outdoors</description>
    <arm_group_label>Preventative Skin Care Routine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Limited Sun Exposure</intervention_name>
    <description>Limit sun exposure during peak hours of 10am-4pm</description>
    <arm_group_label>Preventative Skin Care Routine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dilute bleach baths</intervention_name>
    <description>Warm 10-15 minute dilute bleach baths every other day</description>
    <arm_group_label>Preventative Skin Care Routine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with a brain tumor between ages 6 months old -18 years old and will undergo&#xD;
             treatment with at least one of the following:&#xD;
&#xD;
               1. Targeted BRAF inhibitor therapy to treat the brain tumor&#xD;
&#xD;
               2. Targeted MEK inhibitor therapy to treat the brain tumor&#xD;
&#xD;
               3. Targeted pan-RAF inhibitor therapy to treat the brain tumor&#xD;
&#xD;
          -  Subjects may participate in other studies, including therapeutic trials.&#xD;
&#xD;
          -  Ability to comply with PSCR including sun protection, gentle skin care and every other&#xD;
             day dilute bleach baths.&#xD;
&#xD;
          -  Ability to understand and/or the willingness of their parent or legally authorized&#xD;
             representative to sign a written informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with brain tumor at &gt; 18 years old&#xD;
&#xD;
          -  No data in medical records regarding treatment exposures&#xD;
&#xD;
          -  Treated with a BRAF, MEK or pan-RAF inhibitor in the last three months&#xD;
&#xD;
          -  Past or present allergic reaction to bleach&#xD;
&#xD;
          -  Past or present allergic reactions to sunscreen and/or creams, lotions, emollients to&#xD;
             be utilized in this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer Huang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>February 8, 2023</last_update_submitted>
  <last_update_submitted_qc>February 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dana-Farber Cancer Institute</investigator_affiliation>
    <investigator_full_name>Jennifer Huang, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Pediatric Cancer</keyword>
  <keyword>CNS Tumor, Childhood</keyword>
  <keyword>Skin Inflammation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Central Nervous System Neoplasms</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Data can be shared no earlier than 1 year following the date of publication</ipd_time_frame>
    <ipd_access_criteria>Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu</ipd_access_criteria>
  </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/NCT04479514
org study id: 19-579
nct id: NCT04479514
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This research study is examining a preventive skin care regimen for children diagnosed with a
      brain tumor and receiving anti-cancer therapy with a MEK, Pan-RAF, or BRAF inhibitor.
This prospective, single-arm phase 2 clinical trial is looking at whether gentle skin care,
      sun protection and dilute bleach baths might decrease the chances or the severity of skin
      changes that occur during treatment for brain tumors.

      The research study procedures include screening for eligibility and study treatment including
      evaluations and follow up visits.

      Participants will receive a study treatment regimen that involves a daily sun protection,
      daily gentle skin care and every-other-day dilute bleach baths for the duration of the study.

      Participants enrolled in this study, will be in this research study during the course of
      their anti-cancer treatment and receive skin examinations and complete a survey about their
      skin condition at the initial visit when anti-cancer treatment is started, at six weeks after
      the start of anti-cancer treatment, and at twelve weeks after the start of anti-cancer
      treatment.

      Participants will be followed for twelve weeks.

      It is expected that about 20 people will take part in this research study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Rate of Cutaneous Reaction
time frame: 12 weeks
description: Proportion (percentage) of patients with one or more cutaneous reaction to targeted BRAF, MEK, or Pan-RAF inhibitor therapy
measure: Overall Cutaneous Reaction Severity
time frame: 12 weeks
description: Measured by the Common Terminology Criteria for Adverse Events (CTCAE)
measure: Xerosis Severity
time frame: 12 weeks
description: Measured by the Overall Dry Skin Score (ODS)
measure: Hand foot syndrome Severity
time frame: 12 weeks
description: Measured by the Hand-Foot Skin Reaction and Quality of Life Score (HFS-14)
measure: Pediatric Quality of life
time frame: 12 weeks
description: Pediatric Quality of Life Inventory (PedsQL)
measure: Children's Dermatology Quality of life
time frame: 12 weeks
description: Children's Dermatology Life Quality Index (CDLQI)
arm group label: Preventative Skin Care Routine
arm group type: Experimental
description: Participants will perform a preventative skin care routine that includes daily sun protection, daily gentle skin care and every-other-day dilute bleach baths for the duration of the study.
Participants will receive skin examinations and complete a survey about their skin condition at the initial visit when anti-cancer treatment is started, at six weeks after the start of treatment, and at twelve weeks after the start of treatment.
intervention type: Other
intervention name: Warm Baths or Showers
description: Daily warm baths or showers
arm group label: Preventative Skin Care Routine
intervention type: Other
intervention name: Moisturizer
description: moisturizers applied daily immediately after bathing
arm group label: Preventative Skin Care Routine
intervention type: Drug
intervention name: SPF 30 or Higher Suncreen
description: Mineral based sunscreen of SPF 30 or higher applied on a daily basis on all sun exposed areas.
arm group label: Preventative Skin Care Routine
other name: i.e. Neutrogena, Aveeno, Cerave, Blue Lizard
intervention type: Other
intervention name: Sun Protective Clothing
description: Sun protective clothing worn when outdoors
arm group label: Preventative Skin Care Routine
intervention type: Behavioral
intervention name: Limited Sun Exposure
description: Limit sun exposure during peak hours of 10am-4pm
arm group label: Preventative Skin Care Routine
intervention type: Other
intervention name: Dilute bleach baths
description: Warm 10-15 minute dilute bleach baths every other day
arm group label: Preventative Skin Care Routine
criteria: 
gender: All
minimum age: 6 Months
maximum age: 18 Years
healthy volunteers: No
last name: Jennifer Huang, MD
role: Principal Investigator
affiliation: Boston Children's Hospital
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Dana-Farber Cancer Institute
investigator full name: Jennifer Huang, MD
investigator title: Principal Investigator
mesh term: Central Nervous System Neoplasms
mesh term: Dermatitis
mesh term: Inflammation
sharing ipd: Yes
ipd description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Data can be shared no earlier than 1 year following the date of publication
ipd access criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu