<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/NCT02251392</url>
  </required_header>
  <id_info>
    <org_study_id>UBrasilia</org_study_id>
    <nct_id>NCT02251392</nct_id>
  </id_info>
  <brief_title>Evaluation of Therapeutic Efficacy in Use of Chamomilla Gel, Chamomilla Infuse and Urea in Radiodermatitis</brief_title>
  <acronym>ChamomillaTH</acronym>
  <official_title>Evaluation of Therapeutic Efficacy in Use of Chamomila Gel, Chamomila Infuse and Urea in Patients With Breast or Head and Neck Cancer That Developed Radiodermatitis</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>
    <collaborator>
      <agency>Conselho Nacional de Desenvolvimento Científico e Tecnológico</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>
      This study aims to evaluate therapeutics interventions in radiodermatitis in patients with&#xD;
      breast or head and neck cancer. The data collect is going to begin after determining the&#xD;
      better dose in a dose-response curve that is being conduct now in the same institution. To&#xD;
      evaluate the skin reaction will be applied scale of the Radiation Therapy Oncology Group&#xD;
      (RTOG) - Acute Radiation Morbidity Scoring Criteria, Common Terminology Criteria for Adverse&#xD;
      Events (CTCAE) and Radiation-Induced Skin Reaction Assessment Scale (RISRAS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypothesis:&#xD;
&#xD;
      Chamomila gel is more effective than urea (usual care); Chamomila infuse is more effective&#xD;
      than urea (usual care); Chamomila gel is more effective than chamomila infuse; Chamomila&#xD;
      infuse is more effective than chamomila gel; Chamomila gel is as effective than urea (usual&#xD;
      care); Chamomila infuse is as effective than urea (usual care); Chamomila gel is as effective&#xD;
      than chamomila infuse; Chamomila infuse is as effective than chamomila gel.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>August 2015</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">July 2016</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction of the severity of radiodermatitis, according to the RTOG score.</measure>
    <time_frame>5 weeks</time_frame>
    <description>This outcome is going to be evaluated weekly by the analisys of the signs and symptoms of radiodermititis ant the RTOG score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Radiation Dose</measure>
    <time_frame>5 weeks</time_frame>
    <description>radiation total dose and fraction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiodermititis Cure</measure>
    <time_frame>8 weeks</time_frame>
    <description>The time that pacient don´t have more the radiodermititis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to reduce the severity of radiodermatitis</measure>
    <time_frame>5 weeks</time_frame>
    <description>This outcome is going to be evaluated weekly by the analisys of the time of reduce the signs and symptoms of radiodermititis ant the RTOG score</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Radiodermatitis</condition>
  <arm_group>
    <arm_group_label>Chamomila recutita Gel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental Group 1 - patients will apply the gel since the begging of radiodermatitis, three times a day. The dose is being determined in a Phase II study that is being conducted. Topical application of gel is going to occur concomitantly to the initiation of radiodermatitis and will be follow up until the cure of it.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chamomila recutita Infuse 2,5%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental Group 2 - patients will apply the infuse since the begging of radiodermatitis, three times a day. The dose of 2,5% was determined before in a Phase II study. Radiodermatitis grade and intensity is going to be evaluated. Topical application of the infuse is going to occur concomitantly to the initiation of radiodermatitis and will be follow up until the cure of it.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Urea cream based</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control Group - usual care to treat radiodermatitis, patients will apply the infuse since the begging of radiodermatitis, three times a day. Radiodermatitis grade and intensity is going to be evaluated. Topical application of urea is going to occur concomitantly to the initiation of radiodermatitis and will be follow up until the cure of it.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Chamomila recutita Gel</intervention_name>
    <description>Gel formulated with active principles from Chamomilla recutita which dose is being determined in a dose-response curve</description>
    <arm_group_label>Chamomila recutita Gel</arm_group_label>
    <other_name>Chamomile Gel, Chamomila recutita gel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Chamomila recutita Infuse</intervention_name>
    <description>chamomila infuse in a concentration of 2,5% already determined in a dose response curve</description>
    <arm_group_label>Chamomila recutita Infuse 2,5%</arm_group_label>
    <other_name>Chamomile Infuse, Chamomila recutita infuse</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Urea cream based</intervention_name>
    <description>Urea is already using to treat radiodermatitis when it starts to occur, so it will be the usual care</description>
    <arm_group_label>Urea cream based</arm_group_label>
    <other_name>Urea cream</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Being an adult, over the age of 18 years old; Owning diagnosis of breast or head and neck&#xD;
        cancer; Being first referred to the radiotherapy protocol; Presenting radiodermatitis&#xD;
        grades 1 or 2, second RTOG score, in the place where is receiving radiation therapy; No&#xD;
        history of previous hypersensitivity reaction to chamomile or any plant of the Asteraceae&#xD;
        or Compositae family or Urea; Demonstrate understanding to continue the intervention in&#xD;
        their home environment when necessary.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Medical prescription, during the process of data collection, some kind of intervention to&#xD;
        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>Elaine B Ferreira, Nurse</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Brasilia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Priscila MS Bontempo, Nurse</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of Brasilia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marcia A Ciol, Biostatistcs</last_name>
    <role>Study Director</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Karine RM Silva, Nurse</last_name>
    <role>Study Chair</role>
    <affiliation>University of Brasilia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carlos J Sacramento, Nurse</last_name>
    <role>Study Chair</role>
    <affiliation>University of Brasilia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Paula ED Reis, PhD, Nurse</last_name>
    <role>Study Director</role>
    <affiliation>University of Brasilia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Samuel R Avelino, MP</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of Brasilia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Leandro X Cardoso, Physics</last_name>
    <role>Study Chair</role>
    <affiliation>University of Brasilia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Luis FO Silva, MP</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital of Brasilia</affiliation>
  </overall_official>
  <reference>
    <citation>Reis PE, Carvalho EC, Bueno PC, Bastos JK. Clinical application of Chamomilla recutita in phlebitis: dose response curve study. Rev Lat Am Enfermagem. 2011 Jan-Feb;19(1):3-10. doi: 10.1590/s0104-11692011000100002.</citation>
    <PMID>21412623</PMID>
  </reference>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 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>PAULA ELAINE DINIZ DOS REIS</investigator_full_name>
    <investigator_title>PROFESSOR</investigator_title>
  </responsible_party>
  <keyword>chamomilla</keyword>
  <keyword>matricaria</keyword>
  <keyword>chamomile</keyword>
  <keyword>chamomila</keyword>
  <keyword>recutita</keyword>
  <keyword>Breast Neoplasms</keyword>
  <keyword>head and neck neoplasms</keyword>
  <keyword>radiotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT02251392
org study id: UBrasilia
nct id: NCT02251392
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This study aims to evaluate therapeutics interventions in radiodermatitis in patients with
      breast or head and neck cancer. The data collect is going to begin after determining the
      better dose in a dose-response curve that is being conduct now in the same institution. 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).
Hypothesis:

      Chamomila gel is more effective than urea (usual care); Chamomila infuse is more effective
      than urea (usual care); Chamomila gel is more effective than chamomila infuse; Chamomila
      infuse is more effective than chamomila gel; Chamomila gel is as effective than urea (usual
      care); Chamomila infuse is as effective than urea (usual care); Chamomila gel is as effective
      than chamomila infuse; Chamomila infuse is as effective than chamomila gel.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Reduction of the severity of radiodermatitis, according to the RTOG score.
time frame: 5 weeks
description: This outcome is going to be evaluated weekly by the analisys of the signs and symptoms of radiodermititis ant the RTOG score
measure: Radiation Dose
time frame: 5 weeks
description: radiation total dose and fraction
measure: Radiodermititis Cure
time frame: 8 weeks
description: The time that pacient don´t have more the radiodermititis
measure: Time to reduce the severity of radiodermatitis
time frame: 5 weeks
description: This outcome is going to be evaluated weekly by the analisys of the time of reduce the signs and symptoms of radiodermititis ant the RTOG score
arm group label: Chamomila recutita Gel
arm group type: Experimental
description: Experimental Group 1 - patients will apply the gel since the begging of radiodermatitis, three times a day. The dose is being determined in a Phase II study that is being conducted. Topical application of gel is going to occur concomitantly to the initiation of radiodermatitis and will be follow up until the cure of it.
arm group label: Chamomila recutita Infuse 2,5%
arm group type: Experimental
description: Experimental Group 2 - patients will apply the infuse since the begging of radiodermatitis, three times a day. The dose of 2,5% was determined before in a Phase II study. Radiodermatitis grade and intensity is going to be evaluated. Topical application of the infuse is going to occur concomitantly to the initiation of radiodermatitis and will be follow up until the cure of it.
arm group label: Urea cream based
arm group type: Active Comparator
description: Control Group - usual care to treat radiodermatitis, patients will apply the infuse since the begging of radiodermatitis, three times a day. Radiodermatitis grade and intensity is going to be evaluated. Topical application of urea is going to occur concomitantly to the initiation of radiodermatitis and will be follow up until the cure of it.
intervention type: Other
intervention name: Chamomila recutita Gel
description: Gel formulated with active principles from Chamomilla recutita which dose is being determined in a dose-response curve
arm group label: Chamomila recutita Gel
other name: Chamomile Gel, Chamomila recutita gel
intervention type: Other
intervention name: Chamomila recutita Infuse
description: chamomila infuse in a concentration of 2,5% already determined in a dose response curve
arm group label: Chamomila recutita Infuse 2,5%
other name: Chamomile Infuse, Chamomila recutita infuse
intervention type: Drug
intervention name: Urea cream based
description: Urea is already using to treat radiodermatitis when it starts to occur, so it will be the usual care
arm group label: Urea cream based
other name: Urea cream
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elaine B Ferreira, Nurse
role: Principal Investigator
affiliation: University of Brasilia
last name: Priscila MS Bontempo, Nurse
role: Principal Investigator
affiliation: University Hospital of Brasilia
last name: Marcia A Ciol, Biostatistcs
role: Study Director
affiliation: University of Washington
last name: Karine RM Silva, Nurse
role: Study Chair
affiliation: University of Brasilia
last name: Carlos J Sacramento, Nurse
role: Study Chair
affiliation: University of Brasilia
last name: Paula ED Reis, PhD, Nurse
role: Study Director
affiliation: University of Brasilia
last name: Samuel R Avelino, MP
role: Principal Investigator
affiliation: University Hospital of Brasilia
last name: Leandro X Cardoso, Physics
role: Study Chair
affiliation: University of Brasilia
last name: Luis FO Silva, MP
role: Study Chair
affiliation: University Hospital of Brasilia
citation: Reis PE, Carvalho EC, Bueno PC, Bastos JK. Clinical application of Chamomilla recutita in phlebitis: dose response curve study. Rev Lat Am Enfermagem. 2011 Jan-Feb;19(1):3-10. doi: 10.1590/s0104-11692011000100002.
PMID: 21412623
responsible party type: Principal Investigator
investigator affiliation: University of Brasilia
investigator full name: PAULA ELAINE DINIZ DOS REIS
investigator title: PROFESSOR
mesh term: Radiodermatitis