<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/NCT02249884</url>
  </required_header>
  <id_info>
    <org_study_id>DRCradiodermatitis</org_study_id>
    <nct_id>NCT02249884</nct_id>
  </id_info>
  <brief_title>Dose-Response Curve: Interventions to Prevent and Treat Radiodermatitis</brief_title>
  <acronym>DRCPTR</acronym>
  <official_title>Use of Chamomilla Recutita Gel and Urea Cream to Prevent and Treat Radiodermatitis: Phase 2 Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Brasilia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Brasilia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dose response curve to define the security and tolerable dose to be used for prevention and&#xD;
      treatment of radiodermatitis in patients with breast or head and neck cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is being conducted in Center for High Complexity Oncology (CACON) located at the&#xD;
      University Hospital of Brasília (HUB). Has as its target population subjects diagnosed with&#xD;
      breast and head and neck cancer undergoing radiotherapy. Three doses of urea cream are being&#xD;
      tested. Participants are subjected to simple randomization technique, in which the members of&#xD;
      the study are directly allocated in groups set forth, without any intermediate step. Patients&#xD;
      are identified, go to a nursing consultation for general orientations about treatment. After&#xD;
      the consultation, patients are invited to participate in the study. The patient should&#xD;
      express its acceptance through the informed consent form. Data are being collected through&#xD;
      interviews and medical records. Patients are being evaluated during three weeks, considering&#xD;
      the toxicity of the intervention and the beginning of radiodermatitis. To evaluate the skin&#xD;
      reaction will be applied scale of the Radiation Therapy Oncology Group (RTOG) - Acute&#xD;
      Radiation Morbidity Scoring Criteria, Common Terminology Criteria for Adverse Events (CTCAE)&#xD;
      and Radiation-Induced Skin Reaction Assessment Scale (RISRAS). For reliable assessment and&#xD;
      record of the evolution throughout the treatment and study, patients will be photographed&#xD;
      weekly (D0, D5, D10, D15). Will be photographed major regions subject to evaluation: frontal,&#xD;
      right side profile and left side profile with Photographic camera Nikon P510. The data will&#xD;
      be inserted into Statistical Package for Social Sciences (SPSS), version 18.0, for the&#xD;
      analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2014</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time of occurrence of Radiodermatitis</measure>
    <time_frame>3 weeks</time_frame>
    <description>Time of occurrence of Radiodermatitis according with the Radiation Therapy Oncology Group (RTOG).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Indicators of toxicity</measure>
    <time_frame>3 weeks</time_frame>
    <description>Evaluate the tolerance and safety of the intervention according to the assessment of toxicity during the intervention.&#xD;
To evaluate the toxicity will be considered signs and symptoms referable to the region of application of the product, such as skin rash, urticaria, vesicles, blisters, pustules, as well as the patient's report of discomfort, burning, stinging and itching.</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Radiodermatitis</condition>
  <arm_group>
    <arm_group_label>Urea Dose A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Topical application of the urea cream in concentration A. The product should be applied on the skin three times daily over 3 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Urea Dose B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Topical application of the urea cream in concentration B. The product should be applied on the skin three times daily over 3 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Urea Dose C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Topical application of the urea cream in concentration C. The product should be applied on the skin three times daily over 3 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chamomile Dose A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Topical application of chamomile recutita gel in concentration A. The product should be applied on the skin three times daily over 3 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chamomile Dose B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Topical application of chamomile recutita gel in concentration B. The product should be applied on the skin three times daily over 3 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chamomile Dose C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Topical application of chamomile recutita gel in concentration C. The product should be applied on the skin three times daily over 3 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Urea Dose A</intervention_name>
    <description>Urea cream for topical use.</description>
    <arm_group_label>Urea Dose A</arm_group_label>
    <other_name>Urea cream</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Urea Dose B</intervention_name>
    <description>Urea cream for topical use.</description>
    <arm_group_label>Urea Dose B</arm_group_label>
    <other_name>Urea cream</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Urea Dose C</intervention_name>
    <description>Urea cream for topical use.</description>
    <arm_group_label>Urea Dose C</arm_group_label>
    <other_name>Urea cream.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chamomile Dose A</intervention_name>
    <description>Chamomile gel for topical use.</description>
    <arm_group_label>Chamomile Dose A</arm_group_label>
    <other_name>Chamomile gel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chamomile Dose B</intervention_name>
    <description>Chamomile gel for topical use.</description>
    <arm_group_label>Chamomile Dose B</arm_group_label>
    <other_name>Chamomile gel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chamomile Dose C</intervention_name>
    <description>Chamomile gel for topical use.</description>
    <arm_group_label>Chamomile Dose C</arm_group_label>
    <other_name>Chamomile gel</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 breast or head and neck cancer&#xD;
&#xD;
          -  Being first referred to the radiotherapy protocol&#xD;
&#xD;
          -  Have absence of radiodermatitis and integrates skin to start radiotherapy&#xD;
&#xD;
          -  Not have presented anticipated reaction of hypersensitivity to chamomile or any plant&#xD;
             of the family Asteraceae or Compositae or urea.&#xD;
&#xD;
          -  Demonstrate conditions to continue the intervention in their home environment when&#xD;
             needed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical prescription for the procedure of data collection, some kind of intervention&#xD;
             to prevent radiodermatitis.&#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>Paula Elaine D 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>
        <state>Distrito Federal</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>September 20, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>November 30, 2015</last_update_submitted>
  <last_update_submitted_qc>November 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2015</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>RN, University of Brasilia</investigator_title>
  </responsible_party>
  <keyword>radiodermatitis</keyword>
  <keyword>head and neck neoplasms</keyword>
  <keyword>Breast Neoplasms</keyword>
  <keyword>Urea</keyword>
  <keyword>Matricaria</keyword>
  <keyword>chamomilla</keyword>
  <keyword>chamomile</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Radiodermatitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carbamide Peroxide</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/NCT02249884
org study id: DRCradiodermatitis
nct id: NCT02249884
lead sponsor: 
collaborator: 
has dmc: No
Dose response curve to define the security and tolerable dose to be used for prevention and
      treatment of radiodermatitis in patients with breast or head and neck cancer.
The study is being conducted in Center for High Complexity Oncology (CACON) located at the
      University Hospital of Brasília (HUB). Has as its target population subjects diagnosed with
      breast and head and neck cancer undergoing radiotherapy. Three doses of urea cream are being
      tested. Participants are subjected to simple randomization technique, in which the members of
      the study are directly allocated in groups set forth, without any intermediate step. Patients
      are identified, go to a nursing consultation for general orientations about treatment. After
      the consultation, patients are invited to participate in the study. The patient should
      express its acceptance through the informed consent form. Data are being collected through
      interviews and medical records. Patients are being evaluated during three weeks, considering
      the toxicity of the intervention and the beginning of radiodermatitis. To evaluate the skin
      reaction will be applied scale of the Radiation Therapy Oncology Group (RTOG) - Acute
      Radiation Morbidity Scoring Criteria, Common Terminology Criteria for Adverse Events (CTCAE)
      and Radiation-Induced Skin Reaction Assessment Scale (RISRAS). For reliable assessment and
      record of the evolution throughout the treatment and study, patients will be photographed
      weekly (D0, D5, D10, D15). Will be photographed major regions subject to evaluation: frontal,
      right side profile and left side profile with Photographic camera Nikon P510. The data will
      be inserted into Statistical Package for Social Sciences (SPSS), version 18.0, for the
      analysis.
allocation: Randomized
intervention model: Parallel Assignment
masking: Double (Participant, Outcomes Assessor)
measure: Time of occurrence of Radiodermatitis
time frame: 3 weeks
description: Time of occurrence of Radiodermatitis according with the Radiation Therapy Oncology Group (RTOG).
measure: Indicators of toxicity
time frame: 3 weeks
description: Evaluate the tolerance and safety of the intervention according to the assessment of toxicity during the intervention.
To evaluate the toxicity will be considered signs and symptoms referable to the region of application of the product, such as skin rash, urticaria, vesicles, blisters, pustules, as well as the patient's report of discomfort, burning, stinging and itching.
arm group label: Urea Dose A
arm group type: Experimental
description: Topical application of the urea cream in concentration A. The product should be applied on the skin three times daily over 3 weeks.
arm group label: Urea Dose B
arm group type: Experimental
description: Topical application of the urea cream in concentration B. The product should be applied on the skin three times daily over 3 weeks.
arm group label: Urea Dose C
arm group type: Experimental
description: Topical application of the urea cream in concentration C. The product should be applied on the skin three times daily over 3 weeks.
arm group label: Chamomile Dose A
arm group type: Experimental
description: Topical application of chamomile recutita gel in concentration A. The product should be applied on the skin three times daily over 3 weeks.
arm group label: Chamomile Dose B
arm group type: Experimental
description: Topical application of chamomile recutita gel in concentration B. The product should be applied on the skin three times daily over 3 weeks.
arm group label: Chamomile Dose C
arm group type: Experimental
description: Topical application of chamomile recutita gel in concentration C. The product should be applied on the skin three times daily over 3 weeks.
intervention type: Drug
intervention name: Urea Dose A
description: Urea cream for topical use.
arm group label: Urea Dose A
other name: Urea cream
intervention type: Drug
intervention name: Urea Dose B
description: Urea cream for topical use.
arm group label: Urea Dose B
other name: Urea cream
intervention type: Drug
intervention name: Urea Dose C
description: Urea cream for topical use.
arm group label: Urea Dose C
other name: Urea cream.
intervention type: Drug
intervention name: Chamomile Dose A
description: Chamomile gel for topical use.
arm group label: Chamomile Dose A
other name: Chamomile gel
intervention type: Drug
intervention name: Chamomile Dose B
description: Chamomile gel for topical use.
arm group label: Chamomile Dose B
other name: Chamomile gel
intervention type: Drug
intervention name: Chamomile Dose C
description: Chamomile gel for topical use.
arm group label: Chamomile Dose C
other name: Chamomile gel
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paula Elaine D 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: RN, University of Brasilia
mesh term: Radiodermatitis
mesh term: Carbamide Peroxide