<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/NCT02247830</url>
  </required_header>
  <id_info>
    <org_study_id>radiodermatite01</org_study_id>
    <nct_id>NCT02247830</nct_id>
  </id_info>
  <brief_title>Management Radiodermatitis in Patients With Breast or Head and Neck Cancer</brief_title>
  <acronym>PRBHNC</acronym>
  <official_title>Prophylactic Interventions in the Management of Radiodermatitis in Patients With Breast or Head and Neck Cancer: a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Brasilia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Brasilia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It aims to evaluate the efficacy of the chamomile recutita gel and urea cream in the&#xD;
      prevention of radiodermatitis in patients with breast cancer or head and neck cancer&#xD;
      undergoing radiotherapy.&#xD;
&#xD;
      Prophylactic Trial will consist of a control group and two experimental groups, namely&#xD;
      control group (usual care), Experimental Group 01 (usual care + topical application of the&#xD;
      gel C. recutita) and Experimental Group 02 (usual care + topical application of Urea based&#xD;
      cream).&#xD;
&#xD;
      The doses used in the different compounds are being in test since february 2014 by a&#xD;
      dose-response curve study, using 6 groups with three doses of urea cream and three doses of&#xD;
      C. recutita gel.&#xD;
&#xD;
      The study will be conducted at the Center for High Complexity Oncology at University Hospital&#xD;
      of Brasília (CACON/HUB), Brazil. The degree of radiodermatitis is evaluated weekly, according&#xD;
      to established criteria to classify the effects of radiotherapy, which identifies grades 0,&#xD;
      1, 2 , 3 and 4, according to the score of the Radiation Therapy Oncology Group - RTOG. To&#xD;
      evaluate the skin reaction will also be applied scale Common Terminology Criteria for Adverse&#xD;
      Events (CTCAE) and Radiation-Induced Skin Reaction Assessment Scale (RISRAS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is considered that patients undergoing radiotherapy in use gel based on C. recutita or use&#xD;
      of cream based urea three times a day, concomitant radiotherapy, would present the following&#xD;
      hypotheses:&#xD;
&#xD;
        -  Null: equal incidence and severity of radiodermatitis when compared to the control group&#xD;
           (usual care);&#xD;
&#xD;
        -  Alternative 1: low incidence and severity of radiodermatitis when compared to patients&#xD;
           who comprised the control group (usual care).&#xD;
&#xD;
        -  Alternative 2: lower incidence and severity of radiodermatitis between the experimental&#xD;
           groups (urea and chamomile).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2015</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of radiodermatitis</measure>
    <time_frame>5 weeks</time_frame>
    <description>Time of occurrence of radiodermatitis second dose of radiation (or its absence during radiotherapy).</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Radiodermatitis</condition>
  <arm_group>
    <arm_group_label>1 Chamomilla recutita gel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental Group 01: usual care + topical application of the gel recutita chamomile. Such intervention will be characterized by topical application of the gel C. recutita, concomitantly to the initiation of radiotherapy, should be applied on the irradiated three times daily throughout the period of realization of radiotherapy sessions area, and nursing consultations with equipment instructional (usual care).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2 Urea cream</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental Group 02: usual care + Topical Application of Urea cream. The intervention will be characterized by topical application of urea-based cream on the area irradiated three times daily throughout the period of realization of radiotherapy sessions, in addition to nursing consultation with instructional material (usual care).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group (Usual Care)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The usual care consists of nursing consultation with instructional material (Manual guidelines) that is already done systematically in service. This query is made with all patients starting radiotherapy. Here, guidelines are provided about skin care and hydration, using topical moisturizing soap solution over the bath. Such information is contained in the manual that is provided to the patient during the consultation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Chamomilla recutita gel</intervention_name>
    <description>Such intervention will be characterized by topical application of C. recutita gel, concomitantly to the initiation of radiotherapy, should be applied on the irradiated region three times daily throughout the period of realization of radiotherapy sessions area, and nursing consultations with equipment instructional (usual care).</description>
    <arm_group_label>1 Chamomilla recutita gel</arm_group_label>
    <other_name>matricaria gel</other_name>
    <other_name>chamomilla gel</other_name>
    <other_name>chamomile gel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Urea cream</intervention_name>
    <description>Experimental Group 02: usual care + Topical Application of Urea cream. The intervention will be characterized by topical application of urea-based cream on the irradiated region three times daily throughout the period of realization of radiotherapy sessions, in addition to nursing consultation with instructional material (usual care).</description>
    <arm_group_label>2 Urea cream</arm_group_label>
    <other_name>Urea cream based</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being an adult, over the age of 18 years old;&#xD;
&#xD;
          -  Owning diagnosis of malignant breast or head and neck;&#xD;
&#xD;
          -  Being first referred to the radiotherapy protocol;&#xD;
&#xD;
          -  Agree to participate, expressing his acceptance by signing the Informed Consent Form&#xD;
             (ICF);&#xD;
&#xD;
          -  Present absence of dermatitis to initiation of radiotherapy;&#xD;
&#xD;
          -  Demonstrate understanding of and conditions to continue the intervention in their home&#xD;
             environment when needed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Reports of previous hypersensitivity reaction or presentation, during the research,&#xD;
             adverse reaction to chamomile or any plant of the Asteraceae or compositae family, or&#xD;
             urea;&#xD;
&#xD;
          -  Medical prescription for the procedure of data collection, some kind of intervention&#xD;
             to prevent radiodermatitis;&#xD;
&#xD;
          -  Withdrawal of the patient to remain in the study, independent of time.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elaine Barros Ferreira, RN</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Brasilia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Paula Elaine Diniz dos Reis, RN, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Brasilia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marcia A Ciol, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital of Brasília</name>
      <address>
        <city>Brasilia</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>September 19, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>October 7, 2020</last_update_submitted>
  <last_update_submitted_qc>October 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Brasilia</investigator_affiliation>
    <investigator_full_name>Elaine Barros Ferreira</investigator_full_name>
    <investigator_title>Nurse</investigator_title>
  </responsible_party>
  <keyword>Radiodermatitis</keyword>
  <keyword>Head and neck neoplasms</keyword>
  <keyword>Radiotherapy</keyword>
  <keyword>Urea</keyword>
  <keyword>Matricaria</keyword>
  <keyword>Breast Neoplasms</keyword>
  <keyword>chamomilla</keyword>
  <keyword>chamomile</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</mesh_term>
    <mesh_term>Radiodermatitis</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/NCT02247830
org study id: radiodermatite01
nct id: NCT02247830
lead sponsor: 
has dmc: No
It aims to evaluate the efficacy of the chamomile recutita gel and urea cream in the
      prevention of radiodermatitis in patients with breast cancer or head and neck cancer
      undergoing radiotherapy.

      Prophylactic Trial will consist of a control group and two experimental groups, namely
      control group (usual care), Experimental Group 01 (usual care + topical application of the
      gel C. recutita) and Experimental Group 02 (usual care + topical application of Urea based
      cream).

      The doses used in the different compounds are being in test since february 2014 by a
      dose-response curve study, using 6 groups with three doses of urea cream and three doses of
      C. recutita gel.

      The study will be conducted at the Center for High Complexity Oncology at University Hospital
      of Brasília (CACON/HUB), Brazil. The degree of radiodermatitis is evaluated weekly, according
      to established criteria to classify the effects of radiotherapy, which identifies grades 0,
      1, 2 , 3 and 4, according to the score of the Radiation Therapy Oncology Group - RTOG. To
      evaluate the skin reaction will also be applied scale Common Terminology Criteria for Adverse
      Events (CTCAE) and Radiation-Induced Skin Reaction Assessment Scale (RISRAS).
It is considered that patients undergoing radiotherapy in use gel based on C. recutita or use
      of cream based urea three times a day, concomitant radiotherapy, would present the following
      hypotheses:

        -  Null: equal incidence and severity of radiodermatitis when compared to the control group
           (usual care);

        -  Alternative 1: low incidence and severity of radiodermatitis when compared to patients
           who comprised the control group (usual care).

        -  Alternative 2: lower incidence and severity of radiodermatitis between the experimental
           groups (urea and chamomile).
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Occurrence of radiodermatitis
time frame: 5 weeks
description: Time of occurrence of radiodermatitis second dose of radiation (or its absence during radiotherapy).
arm group label: 1 Chamomilla recutita gel
arm group type: Experimental
description: Experimental Group 01: usual care + topical application of the gel recutita chamomile. Such intervention will be characterized by topical application of the gel C. recutita, concomitantly to the initiation of radiotherapy, should be applied on the irradiated three times daily throughout the period of realization of radiotherapy sessions area, and nursing consultations with equipment instructional (usual care).
arm group label: 2 Urea cream
arm group type: Experimental
description: Experimental Group 02: usual care + Topical Application of Urea cream. The intervention will be characterized by topical application of urea-based cream on the area irradiated three times daily throughout the period of realization of radiotherapy sessions, in addition to nursing consultation with instructional material (usual care).
arm group label: Control Group (Usual Care)
arm group type: No Intervention
description: The usual care consists of nursing consultation with instructional material (Manual guidelines) that is already done systematically in service. This query is made with all patients starting radiotherapy. Here, guidelines are provided about skin care and hydration, using topical moisturizing soap solution over the bath. Such information is contained in the manual that is provided to the patient during the consultation.
intervention type: Other
intervention name: Chamomilla recutita gel
description: Such intervention will be characterized by topical application of C. recutita gel, concomitantly to the initiation of radiotherapy, should be applied on the irradiated region three times daily throughout the period of realization of radiotherapy sessions area, and nursing consultations with equipment instructional (usual care).
arm group label: 1 Chamomilla recutita gel
other name: matricaria gel
other name: chamomilla gel
other name: chamomile gel
intervention type: Drug
intervention name: Urea cream
description: Experimental Group 02: usual care + Topical Application of Urea cream. The intervention will be characterized by topical application of urea-based cream on the irradiated region three times daily throughout the period of realization of radiotherapy sessions, in addition to nursing consultation with instructional material (usual care).
arm group label: 2 Urea cream
other name: Urea cream based
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Elaine Barros Ferreira, RN
role: Principal Investigator
affiliation: University of Brasilia
last name: Paula Elaine Diniz dos Reis, RN, PhD
role: Study Director
affiliation: University of Brasilia
last name: Marcia A Ciol, PhD
role: Study Director
affiliation: University of Washington
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Brasilia
investigator full name: Elaine Barros Ferreira
investigator title: Nurse
mesh term: Head and Neck Neoplasms
mesh term: Radiodermatitis