<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/NCT02213536</url>
  </required_header>
  <id_info>
    <org_study_id>HCA</org_study_id>
    <nct_id>NCT02213536</nct_id>
  </id_info>
  <brief_title>Investigating the Efficacy of Hair Sparing Radiotherapy Treatment to the Whole Brain.</brief_title>
  <acronym>SPARE</acronym>
  <official_title>Investigating the Efficacy of Scalp Sparing Radiotherapy Treatment to the Whole Brain: Examining the Effect of Hair Loss and Re-growth</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HCA International Limited</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HCA International Limited</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the use of a scalp sparing technique of radiotherapy treatment designed to&#xD;
      treat the whole brain. Current treatment methods to treat the whole brain with radiotherapy&#xD;
      result in complete alopecia as a side effect. Hair loss is usually patchy and uneven and&#xD;
      re-growth similar and slow.&#xD;
&#xD;
      It is hoped that reducing the radiation dose to the hair bearing follicle on the scalp will&#xD;
      reduce hair loss and increase the speed and evenness of re-growth.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale for conducting the SPARE study:&#xD;
&#xD;
      The purpose of this study is to evaluate the effect of delivering WBRT via the VMAT method on&#xD;
      hair loss and subsequent re-growth. Hair loss has been found to have a negative impact on QoL&#xD;
      and can be particularly stressful for patients with a very short life expectancy, this is&#xD;
      already well documented. Trying to minimise this treatment side effect, as previously stated&#xD;
      in the literature, is a worthwhile investigation. This study is not looking at any prescribed&#xD;
      dose changes to the established, evidence based and well documented prescriptions for WBRT.&#xD;
      SPARE is an observational study of hair loss and re-growth during and after a patient's&#xD;
      prescribed clinical treatment.&#xD;
&#xD;
      Aims and Objectives;&#xD;
&#xD;
      1) To observe hair loss and re-growth in patients undergoing Whole Brain Radiotherapy using&#xD;
      the Volumetric Modulated Arc Therapy method of delivery.&#xD;
&#xD;
      As complete alopecia is expected in 100% of patients receiving conventionally delivered WBRT&#xD;
      it will be considered a positive result if complete hair loss does not happen when using VMAT&#xD;
      in this group of patients.&#xD;
&#xD;
      Assessment of hair loss and re-growth.&#xD;
&#xD;
      The assessment of hair loss and subsequent re-growth will be conducted using both objective&#xD;
      and subjective assessments:&#xD;
&#xD;
        1. Objective assessment: Photographic&#xD;
&#xD;
        2. Subjective assessment: Patient interviews \ completion of a hair record sheet.&#xD;
&#xD;
      Photographic assessment:&#xD;
&#xD;
      Initial baseline photographs will be taken before any radiotherapy treatment is delivered on&#xD;
      day one of the treatment schedule. Four photographs in total of the head, two laterals (left&#xD;
      and right sides), the top (superior) and back (posterior). Subsequent serial photographs will&#xD;
      be taken at two weeks, one, two, three, and four months after radiotherapy treatment.&#xD;
&#xD;
      Subjective assessment:&#xD;
&#xD;
      Patients will be asked to give their own opinion on their hair loss \ gain and this will be&#xD;
      recorded on the hair record forms and completed by a member of the study team. This will be&#xD;
      conducted at the same time intervals as the scalp photographs being taken.&#xD;
&#xD;
      Scalp photos will also be assessed by 2 independent members of the research team and scored&#xD;
      using the same scales as the participant. Subsequent follow-up scalp pictures will be&#xD;
      assessed against baseline (day 1) photos or complete alopecia images to assess re-growth.&#xD;
&#xD;
      Planning and Dosimetry:&#xD;
&#xD;
      Treatment plans will be generated using a 2 arc VMAT technique generated on Varian's Eclipse&#xD;
      treatment planning system using 10 MV photons delivered on a Varian Clinac equipped with a&#xD;
      Millennium Multileaf Collimator. Plans will be optimized selecting a maximum dose rate of 600&#xD;
      MU/min.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Poor recruitment and follow up&#xD;
  </why_stopped>
  <start_date>August 2015</start_date>
  <completion_date type="Actual">February 20, 2019</completion_date>
  <primary_completion_date type="Actual">February 20, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>To assess hair loss and hair regrowth in patients undergoing WBRT using VMAT via photographic assessment by independent professionals at intervals up to 16 weeks post end of treatment.</measure>
    <time_frame>4 months post radiotherapy treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>To assess patient perceptions of hair loss and hair regrowth in patients undergoing WBRT using VMAT via self assessment at intervals up to 16 weeks post end of treatment.</measure>
    <time_frame>4 months post radiotherapy treatment end</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">5</enrollment>
  <condition>Metastatic Brain Cancer</condition>
  <arm_group>
    <arm_group_label>VMAT WBRT</arm_group_label>
    <description>Patients requiring whole brain radiotherapy as part of their cancer managment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>VMAT (Volumetric Modulated Arc Therapy)</intervention_name>
    <description>Delivering a prescribed radiation dose to the whole brain using VMAT to reduce dose to hair follicles on scalp.</description>
    <arm_group_label>VMAT WBRT</arm_group_label>
    <other_name>Radiation Therapy</other_name>
    <other_name>Radiation Oncology</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with a positive cancer diagnosis requiring whole brain radiotherapy with a life&#xD;
        expectancy greater than 4 months.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults over 18&#xD;
&#xD;
          -  Positive cancer diagnosis&#xD;
&#xD;
          -  Either proven brain metastasis or prophylaxis for primary lung cancer&#xD;
&#xD;
          -  Have no epilating chemotherapy planned&#xD;
&#xD;
          -  Basic understanding of English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous whole brain radiotherapy&#xD;
&#xD;
          -  Pregnant females&#xD;
&#xD;
          -  Unable to give informed consent&#xD;
&#xD;
          -  Urgent cases that need same or next day treatment when referred&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Landau, DR</last_name>
    <role>Study Chair</role>
    <affiliation>Clinical Oncologist with practising privilages at The Harley Street Clinic, HCA International Limited hospitals.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Harley Street Clinic</name>
      <address>
        <city>London</city>
        <zip>W1G 8PP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <last_update_submitted>February 20, 2019</last_update_submitted>
  <last_update_submitted_qc>February 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>HCA International Limited</investigator_affiliation>
    <investigator_full_name>Lynsey RICE</investigator_full_name>
    <investigator_title>Research and Development radiographer</investigator_title>
  </responsible_party>
  <keyword>Metastatic brain cancer</keyword>
  <keyword>Whole brain radiotherapy</keyword>
  <keyword>Scalp sparing whole brain radiotherapy</keyword>
  <keyword>Prophylactic whole brain radiotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Neoplasms</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/NCT02213536
org study id: HCA
nct id: NCT02213536
lead sponsor: 
has dmc: No
To investigate the use of a scalp sparing technique of radiotherapy treatment designed to
      treat the whole brain. Current treatment methods to treat the whole brain with radiotherapy
      result in complete alopecia as a side effect. Hair loss is usually patchy and uneven and
      re-growth similar and slow.

      It is hoped that reducing the radiation dose to the hair bearing follicle on the scalp will
      reduce hair loss and increase the speed and evenness of re-growth.
Rationale for conducting the SPARE study:

      The purpose of this study is to evaluate the effect of delivering WBRT via the VMAT method on
      hair loss and subsequent re-growth. Hair loss has been found to have a negative impact on QoL
      and can be particularly stressful for patients with a very short life expectancy, this is
      already well documented. Trying to minimise this treatment side effect, as previously stated
      in the literature, is a worthwhile investigation. This study is not looking at any prescribed
      dose changes to the established, evidence based and well documented prescriptions for WBRT.
      SPARE is an observational study of hair loss and re-growth during and after a patient's
      prescribed clinical treatment.

      Aims and Objectives;

      1) To observe hair loss and re-growth in patients undergoing Whole Brain Radiotherapy using
      the Volumetric Modulated Arc Therapy method of delivery.

      As complete alopecia is expected in 100% of patients receiving conventionally delivered WBRT
      it will be considered a positive result if complete hair loss does not happen when using VMAT
      in this group of patients.

      Assessment of hair loss and re-growth.

      The assessment of hair loss and subsequent re-growth will be conducted using both objective
      and subjective assessments:

        1. Objective assessment: Photographic

        2. Subjective assessment: Patient interviews \ completion of a hair record sheet.

      Photographic assessment:

      Initial baseline photographs will be taken before any radiotherapy treatment is delivered on
      day one of the treatment schedule. Four photographs in total of the head, two laterals (left
      and right sides), the top (superior) and back (posterior). Subsequent serial photographs will
      be taken at two weeks, one, two, three, and four months after radiotherapy treatment.

      Subjective assessment:

      Patients will be asked to give their own opinion on their hair loss \ gain and this will be
      recorded on the hair record forms and completed by a member of the study team. This will be
      conducted at the same time intervals as the scalp photographs being taken.

      Scalp photos will also be assessed by 2 independent members of the research team and scored
      using the same scales as the participant. Subsequent follow-up scalp pictures will be
      assessed against baseline (day 1) photos or complete alopecia images to assess re-growth.

      Planning and Dosimetry:

      Treatment plans will be generated using a 2 arc VMAT technique generated on Varian's Eclipse
      treatment planning system using 10 MV photons delivered on a Varian Clinac equipped with a
      Millennium Multileaf Collimator. Plans will be optimized selecting a maximum dose rate of 600
      MU/min.
observational model: Case-Only
time perspective: Prospective
measure: To assess hair loss and hair regrowth in patients undergoing WBRT using VMAT via photographic assessment by independent professionals at intervals up to 16 weeks post end of treatment.
time frame: 4 months post radiotherapy treatment
measure: To assess patient perceptions of hair loss and hair regrowth in patients undergoing WBRT using VMAT via self assessment at intervals up to 16 weeks post end of treatment.
time frame: 4 months post radiotherapy treatment end
arm group label: VMAT WBRT
description: Patients requiring whole brain radiotherapy as part of their cancer managment.
intervention type: Radiation
intervention name: VMAT (Volumetric Modulated Arc Therapy)
description: Delivering a prescribed radiation dose to the whole brain using VMAT to reduce dose to hair follicles on scalp.
arm group label: VMAT WBRT
other name: Radiation Therapy
other name: Radiation Oncology
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Landau, DR
role: Study Chair
affiliation: Clinical Oncologist with practising privilages at The Harley Street Clinic, HCA International Limited hospitals.
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: HCA International Limited
investigator full name: Lynsey RICE
investigator title: Research and Development radiographer
mesh term: Brain Neoplasms