<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/NCT03753776</url>
  </required_header>
  <id_info>
    <org_study_id>2018-0601</org_study_id>
    <secondary_id>2018-002406-32</secondary_id>
    <nct_id>NCT03753776</nct_id>
  </id_info>
  <brief_title>Phase III Trial Evaluating Radium Bromatum Homeopathic Treatment Efficacy on Radiodermatitis Prevention and Treatment for Breast Cancer Women</brief_title>
  <acronym>HOMEORAD</acronym>
  <official_title>Phase III Trial Evaluating Radium Bromatum Homeopathic Treatment Efficacy on Radiodermatitis Prevention and Treatment for Breast Cancer Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut de Cancérologie de la Loire</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Saint Etienne</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Breast cancer is the second most frequent cancer worldwide. Principal therapy consists in&#xD;
      radiotherapy, but this technic has sides effects as radiodermatitis, concerning about 90&#xD;
      percent of women treated.&#xD;
&#xD;
      Risk of flushing could be reduced by hygienic rules, but no treatment proved its efficacy to&#xD;
      prevent radiodermatitis.&#xD;
&#xD;
      Homeopathy is popular but also contested. No clinical trial proved its efficacy for this&#xD;
      indication. The present study aims at evaluating Radium bromatum efficacy (homeopathy),&#xD;
      compared to placebo, to prevent radiodermatitis apparition for women treated for breast&#xD;
      cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Breast cancer is the second most frequent cancer worldwide, and the most frequent in France.&#xD;
      Principal therapy consists in radiotherapy, that is locoregional, using radiations to kill&#xD;
      cancerous cells.&#xD;
&#xD;
      Radiotherapy has sides effects as radiodermatitis, concerning about 90 percent of women&#xD;
      treated. Radiodermatitis could be described with three factors : redness, heat, and edema.&#xD;
&#xD;
      Risk of flushing could be reduced by hygienic rules concerning hydratation, clothes, and&#xD;
      toilet.&#xD;
&#xD;
      Nowadays, no treatment proved homeopathic efficacy to prevent radiodermatitis. This treatment&#xD;
      is popular but also contested. No clinical trial proved its efficacy for this indication. The&#xD;
      present study aims at evaluating Radium bromatum efficacy (homeopathy), compared to placebo,&#xD;
      to prevent radiodermatitis apparition for women treated for breast cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 15, 2019</start_date>
  <completion_date type="Anticipated">March 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>
    <intervention_model_description>A first randomization will establish two groups : placebo versus homeopathy (Radium bromatum), and if patients develop a radiodermatitis of grade 2 or higher, a second randomization will take place, with two groups : placebo versus homeopathy (Radium bromatum, Apis mellifica, and Belladonna)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Neither patients receiving pills nor doctors evaluating radiodermatitis know the nature of treatment (placebo or homeopathy)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage diminution of grade 2 or higher radiodermatitis in Radium bromatum group</measure>
    <time_frame>Week 6</time_frame>
    <description>Percentage diminution of grade 2 or higher radiodermatitis in Radium bromatum group will be measure with the RTOG (Radiation Therapy Oncology Group) scale. A diminution of 10% between Radium bromatum group and placebo group will be considered as significant</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Radiodermatitis frequency</measure>
    <time_frame>Week 6</time_frame>
    <description>Number of Radiodermatitis according to the RTOG (Radiation Therapy Oncology Group) scale will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiodermatitis duration</measure>
    <time_frame>Week 6</time_frame>
    <description>Radiodermatitis duration will be reported in days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiodermatitis delays</measure>
    <time_frame>Week 6</time_frame>
    <description>Radiodermatitis delays will be reported in days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of concomitant treatments</measure>
    <time_frame>Week 6</time_frame>
    <description>Number of concomitant treatments will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain measure</measure>
    <time_frame>Week 6</time_frame>
    <description>Measure of pain will be reported, calculated with a oral scale between 0 and 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of Quality of life</measure>
    <time_frame>Week 6</time_frame>
    <description>Level of Quality of life will be measured between 0 to 100 with the EQ-5D questionnaire (european quality of life number 5)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction measure</measure>
    <time_frame>Week 6</time_frame>
    <description>Satisfaction will be measured with a oral scale between 0 (no satisfaction) and 3 (full satisfaction)</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">232</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Radium bromatum placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo group will receive placebo pills of Radium bromatum during radiotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Radium bromatum group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Radium bromatum group will receive homeopathic Radium bromatum pills during radiotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Radium bromatum/Apis mellifica/Belladonna placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo group will receive Radium bromatum/Apis mellifica/Belladonna placebo pills to treat grade 2 or higher radiodermatitis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Radium bromatum/Apis mellifica/Belladonna group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Radium bromatum/Apis mellifica/Belladonna group will receive homeopathic Radium bromatum/Apis mellifica/Belladonna pills to treat grade 2 or higher radiodermatitis</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo pills of Radium bromatum</intervention_name>
    <description>Placebo pills of Radium bromatum will be taken since 48h before radiotherapy and until 15 days after the end of radiation, or until grade 2 or higher radiodermatitis apparition</description>
    <arm_group_label>Radium bromatum placebo group</arm_group_label>
    <other_name>Radium bromatum placebo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Radium bromatum pills</intervention_name>
    <description>Homeopathic Radium bromatum pills will be taken since 48h before radiotherapy and until 15 days after the end of radiation, or until grade 2 or higher radiodermatitis apparition</description>
    <arm_group_label>Radium bromatum group</arm_group_label>
    <other_name>Radium bromatum</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Radium bromatum/Apis mellifica/Belladonna placebo pills</intervention_name>
    <description>Placebo pills of Radium bromatum, Apis mellifica and Belladonna will be taken since grade 2 or higher radiodermatitis and until 15 days after the end of radiation</description>
    <arm_group_label>Radium bromatum/Apis mellifica/Belladonna placebo group</arm_group_label>
    <other_name>Radium bromatum/Apis mellifica/Belladonna placebo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Radium bromatum/Apis mellifica/Belladonna pills</intervention_name>
    <description>Pills of Radium bromatum, Apis mellifica and Belladonna will be taken since grade 2 or higher radiodermatitis and until 15 days after the end of radiation</description>
    <arm_group_label>Radium bromatum/Apis mellifica/Belladonna group</arm_group_label>
    <other_name>Radium bromatum/Apis mellifica/Belladonna</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Major patient;&#xD;
&#xD;
          -  Indication of curative intent radiotherapy for breast cancer treated with conservative&#xD;
             treatment. Accepted radiotherapy scheme: 50 Gy (main) + 16 Gy on the tumor bed&#xD;
             (additional dose);&#xD;
&#xD;
          -  Patient affiliated or entitled to a social security scheme;&#xD;
&#xD;
          -  Patient who signed an informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating woman;&#xD;
&#xD;
          -  Legal incapacity or limited legal capacity. Medical or psychological conditions that&#xD;
             do not allow the subject to understand the study and sign the consent&#xD;
&#xD;
          -  Patient followed by a liberal homeopath;&#xD;
&#xD;
          -  Patient with bilateral breast cancer;&#xD;
&#xD;
          -  Patient with in situ breast cancer;&#xD;
&#xD;
          -  Patient with known cognitive impairment;&#xD;
&#xD;
          -  Patient with known allergy and / or intolerance and / or malabsorption to fructose,&#xD;
             glucose, galactose;&#xD;
&#xD;
          -  Patient with a known deficiency in sucrase / isomaltase / lactase.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aurélie Beneton, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU de Saint-Etienne</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Aurélie Beneton, MD</last_name>
    <phone>0477917136</phone>
    <phone_ext>+33</phone_ext>
    <email>aurelie.beneton@chu-st-etienne.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mathilde Gras, MsC</last_name>
    <phone>0477917136</phone>
    <phone_ext>+33</phone_ext>
    <email>mathilde.gras@chu-st-etienne.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHU de Saint-Etienne</name>
      <address>
        <city>Saint-Étienne</city>
        <zip>42055</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aurélie Beneton, MD</last_name>
    </contact>
    <investigator>
      <last_name>Aurélie Beneton, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Stéphanie Morisson, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Christelle Brosse, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jane-Chloé Trone, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Anne Bareille, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Thomas Reynaud, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Grégoire Pigné, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>November 22, 2018</study_first_submitted>
  <study_first_submitted_qc>November 22, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>May 4, 2023</last_update_submitted>
  <last_update_submitted_qc>May 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Homeopathy</keyword>
  <keyword>Radium bromatum</keyword>
  <keyword>Apis mellifica</keyword>
  <keyword>Belladonna</keyword>
  <keyword>Radiodermatitis</keyword>
  <keyword>Radiotherapy</keyword>
  <keyword>Prevention</keyword>
  <keyword>Treatment</keyword>
  <keyword>Breast cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Radiodermatitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03753776
org study id: 2018-0601
secondary id: 2018-002406-32
nct id: NCT03753776
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Breast cancer is the second most frequent cancer worldwide. Principal therapy consists in
      radiotherapy, but this technic has sides effects as radiodermatitis, concerning about 90
      percent of women treated.

      Risk of flushing could be reduced by hygienic rules, but no treatment proved its efficacy to
      prevent radiodermatitis.

      Homeopathy is popular but also contested. No clinical trial proved its efficacy for this
      indication. The present study aims at evaluating Radium bromatum efficacy (homeopathy),
      compared to placebo, to prevent radiodermatitis apparition for women treated for breast
      cancer.
Breast cancer is the second most frequent cancer worldwide, and the most frequent in France.
      Principal therapy consists in radiotherapy, that is locoregional, using radiations to kill
      cancerous cells.

      Radiotherapy has sides effects as radiodermatitis, concerning about 90 percent of women
      treated. Radiodermatitis could be described with three factors : redness, heat, and edema.

      Risk of flushing could be reduced by hygienic rules concerning hydratation, clothes, and
      toilet.

      Nowadays, no treatment proved homeopathic efficacy to prevent radiodermatitis. This treatment
      is popular but also contested. No clinical trial proved its efficacy for this indication. The
      present study aims at evaluating Radium bromatum efficacy (homeopathy), compared to placebo,
      to prevent radiodermatitis apparition for women treated for breast cancer.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A first randomization will establish two groups : placebo versus homeopathy (Radium bromatum), and if patients develop a radiodermatitis of grade 2 or higher, a second randomization will take place, with two groups : placebo versus homeopathy (Radium bromatum, Apis mellifica, and Belladonna)
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Neither patients receiving pills nor doctors evaluating radiodermatitis know the nature of treatment (placebo or homeopathy)
measure: Percentage diminution of grade 2 or higher radiodermatitis in Radium bromatum group
time frame: Week 6
description: Percentage diminution of grade 2 or higher radiodermatitis in Radium bromatum group will be measure with the RTOG (Radiation Therapy Oncology Group) scale. A diminution of 10% between Radium bromatum group and placebo group will be considered as significant
measure: Radiodermatitis frequency
time frame: Week 6
description: Number of Radiodermatitis according to the RTOG (Radiation Therapy Oncology Group) scale will be reported.
measure: Radiodermatitis duration
time frame: Week 6
description: Radiodermatitis duration will be reported in days.
measure: Radiodermatitis delays
time frame: Week 6
description: Radiodermatitis delays will be reported in days.
measure: Number of concomitant treatments
time frame: Week 6
description: Number of concomitant treatments will be reported.
measure: Pain measure
time frame: Week 6
description: Measure of pain will be reported, calculated with a oral scale between 0 and 10.
measure: Level of Quality of life
time frame: Week 6
description: Level of Quality of life will be measured between 0 to 100 with the EQ-5D questionnaire (european quality of life number 5)
measure: Satisfaction measure
time frame: Week 6
description: Satisfaction will be measured with a oral scale between 0 (no satisfaction) and 3 (full satisfaction)
arm group label: Radium bromatum placebo group
arm group type: Placebo Comparator
description: Placebo group will receive placebo pills of Radium bromatum during radiotherapy
arm group label: Radium bromatum group
arm group type: Experimental
description: Radium bromatum group will receive homeopathic Radium bromatum pills during radiotherapy
arm group label: Radium bromatum/Apis mellifica/Belladonna placebo group
arm group type: Placebo Comparator
description: Placebo group will receive Radium bromatum/Apis mellifica/Belladonna placebo pills to treat grade 2 or higher radiodermatitis
arm group label: Radium bromatum/Apis mellifica/Belladonna group
arm group type: Experimental
description: Radium bromatum/Apis mellifica/Belladonna group will receive homeopathic Radium bromatum/Apis mellifica/Belladonna pills to treat grade 2 or higher radiodermatitis
intervention type: Drug
intervention name: Placebo pills of Radium bromatum
description: Placebo pills of Radium bromatum will be taken since 48h before radiotherapy and until 15 days after the end of radiation, or until grade 2 or higher radiodermatitis apparition
arm group label: Radium bromatum placebo group
other name: Radium bromatum placebo
intervention type: Drug
intervention name: Radium bromatum pills
description: Homeopathic Radium bromatum pills will be taken since 48h before radiotherapy and until 15 days after the end of radiation, or until grade 2 or higher radiodermatitis apparition
arm group label: Radium bromatum group
other name: Radium bromatum
intervention type: Drug
intervention name: Radium bromatum/Apis mellifica/Belladonna placebo pills
description: Placebo pills of Radium bromatum, Apis mellifica and Belladonna will be taken since grade 2 or higher radiodermatitis and until 15 days after the end of radiation
arm group label: Radium bromatum/Apis mellifica/Belladonna placebo group
other name: Radium bromatum/Apis mellifica/Belladonna placebo
intervention type: Drug
intervention name: Radium bromatum/Apis mellifica/Belladonna pills
description: Pills of Radium bromatum, Apis mellifica and Belladonna will be taken since grade 2 or higher radiodermatitis and until 15 days after the end of radiation
arm group label: Radium bromatum/Apis mellifica/Belladonna group
other name: Radium bromatum/Apis mellifica/Belladonna
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Aurélie Beneton, MD
role: Principal Investigator
affiliation: CHU de Saint-Etienne
last name: Aurélie Beneton, MD
phone: 0477917136
phone ext: +33
email: aurelie.beneton@chu-st-etienne.fr
last name: Mathilde Gras, MsC
phone: 0477917136
phone ext: +33
email: mathilde.gras@chu-st-etienne.fr
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Radiodermatitis
sharing ipd: No