<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/NCT04408560</url>
  </required_header>
  <id_info>
    <org_study_id>2018-A01019-46</org_study_id>
    <nct_id>NCT04408560</nct_id>
  </id_info>
  <brief_title>Evaluation of the Efficacy of a Homeopathic Protocol in Patients With Non-metastatic Breast Cancer</brief_title>
  <acronym>ARHOMA2</acronym>
  <official_title>Evaluation of the Efficacy of a Homeopathic Protocol to Reduce the Onset or Aggravation of Joint Pain or Stiffness Following the Taking of Anti-aromatases (AI) in Patients With Non-metastatic Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Jean-Godinot</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut Jean-Godinot</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Interventional, randomised, prospective, monocentric study&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Interventional, randomised, prospective, monocentric study&#xD;
&#xD;
      Primary objective :&#xD;
&#xD;
      Demonstrate the interest of the homeopathic Protocol to reduce the onset or aggravation of&#xD;
      joint pain as a result of the taking of AI compared to conventional care&#xD;
&#xD;
      Secondary objective :&#xD;
&#xD;
      Compare between the two treatment groups:&#xD;
&#xD;
        -  Evolution of joint pain&#xD;
&#xD;
        -  Evolution of joint stiffness-rate of onset of pain and joint stiffness-delay in onset or&#xD;
           aggravation of pain-evolution of the number of painful locations-evolution of the impact&#xD;
           of pain on the quality of the sleep-consumption of permitted concomitant treatments&#xD;
           (analgesics)&#xD;
&#xD;
        -  Evolution of symptoms of hormonal deprivation-adherence to AI treatment&#xD;
&#xD;
        -  Tolerance to AI&#xD;
&#xD;
        -  Change seen by patients&#xD;
&#xD;
        -  Stop rate and switch of AI-rate of recurrence of breast cancer&#xD;
&#xD;
      Describe in patients receiving homeopathic treatment:&#xD;
&#xD;
        -  Adherence to homeopathic treatment&#xD;
&#xD;
        -  Tolerance to homeopathic treatment&#xD;
&#xD;
        -  Group A: Group of patients receiving conventional treatment (drug analgesic class 1) for&#xD;
           joint pain + homeopathic treatment&#xD;
&#xD;
        -  Group B: Group of patients receiving conventional treatment (drug analgesic class 1) for&#xD;
           joint pain&#xD;
&#xD;
      Schedule :&#xD;
&#xD;
        -  Inclusions start at: 01/09/2018&#xD;
&#xD;
        -  End date of inclusions: 01/09/2021&#xD;
&#xD;
        -  End date of follow-up: 23/03/2022&#xD;
&#xD;
        -  Study report: 23/03/2023&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 13, 2018</start_date>
  <completion_date type="Actual">March 23, 2022</completion_date>
  <primary_completion_date type="Actual">August 27, 2021</primary_completion_date>
  <phase>N/A</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evolution of the score of &quot;most intense pain&quot; during the first 3 months of treatment with AI</measure>
    <time_frame>3 months</time_frame>
    <description>Evaluation comparing between the 2 groups the area under the most intense pain curve, measured each week during the first 3 months of AI treatment using the Brief Pain Inventory-Short Form (BPI-SF) scale (1 no disconfort up to 10 complet disconfort)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evolution of joint pain</measure>
    <time_frame>6 months</time_frame>
    <description>variation of different pain scores on the Brief Pain Inventory-Short Form (BPI-SF) scale (1 no disconfort up to 10 complet disconfort) : pain severity score corresponding to the average of the 4 questions on pain intensity, and interference score corresponding to the average of the 7 questions on the impact of pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of onset of joint pain and stiffness</measure>
    <time_frame>3 months</time_frame>
    <description>For pain, among patients who answered &quot;no&quot; to the first question of Brief Pain Inventory-Short Form (1 no disconfort up to 10 complet disconfort) to visit 1, percentage of patients who answered &quot;Yes&quot; to 3 months (visit 2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of onset of pain and joint stiffness</measure>
    <time_frame>3 months</time_frame>
    <description>Percentage of patients for whom pain and / or stiffness have occurred.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of onset or aggravation of pain</measure>
    <time_frame>6 months</time_frame>
    <description>time from which the &quot;most severe pain&quot; score has increased for at least 2 consecutive weeks since the Visit 1 score</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Breast Cancer Female</condition>
  <condition>Joint Pain</condition>
  <arm_group>
    <arm_group_label>Groupe A with homéopathic treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional treatment : paracetamol (drug analgesic class1) + Homeopathic drug : Rhus toxicodendron 9 CH et Ruta graveolens 5 CH</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Groupe B without homeopathic treatment</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Conventional treatment : paracetamol (drug analgesic class1)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rhus toxicodendron 9 CH + Ruta graveolens 5 CH (Homeopathic Granules)</intervention_name>
    <description>Rhus toxicodendron 9 CH + Ruta graveolens 5 CH</description>
    <arm_group_label>Groupe A with homéopathic treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>paracetamol (drug analgesic class1)</intervention_name>
    <description>paracetamol (drug analgesic class1)</description>
    <arm_group_label>Groupe A with homéopathic treatment</arm_group_label>
    <arm_group_label>Groupe B without homeopathic treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  menopausal patient&#xD;
&#xD;
          -  achieved histologically confirmed non-metastatic breast cancer with positive hormonal&#xD;
             receptors&#xD;
&#xD;
          -  starting an adjuvant anti-hormonal treatment with an AI&#xD;
&#xD;
          -  patient benefiting from a social protection scheme&#xD;
&#xD;
          -  patient mastering the French language -signature of free and informed consent -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient whose treatment with chemotherapy or radiotherapy is ongoing or anticipated&#xD;
             during the theoretical period of the study or patient who has completed her&#xD;
             chemotherapy treatment within a period of less than 4 weeks prior to the inclusion&#xD;
             visit&#xD;
&#xD;
          -  patient with proven inflammatory rheumatism already diagnosed with rheumatoid&#xD;
             arthritis, lupus, psoriatic rheumatism, ankylosing spondylitis -concomitant treatment&#xD;
             with other complementary medicines (excepted Vitamin D), unless the treatment has been&#xD;
             stable for at least 1 month.&#xD;
&#xD;
          -  current treatment with narcotic drugs or corticosteroids&#xD;
&#xD;
          -  patient with overexpressing breast cancer HER2&#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>PHILIPPE GUILBERT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut Jean-Godinot</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Philippe GUILBERT</name>
      <address>
        <city>Reims</city>
        <zip>51100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>April 4, 2019</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>September 16, 2022</last_update_submitted>
  <last_update_submitted_qc>September 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Arthralgia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
    <mesh_term>Analgesics</mesh_term>
  </intervention_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/NCT04408560
org study id: 2018-A01019-46
nct id: NCT04408560
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Interventional, randomised, prospective, monocentric study
Interventional, randomised, prospective, monocentric study

      Primary objective :

      Demonstrate the interest of the homeopathic Protocol to reduce the onset or aggravation of
      joint pain as a result of the taking of AI compared to conventional care

      Secondary objective :

      Compare between the two treatment groups:

        -  Evolution of joint pain

        -  Evolution of joint stiffness-rate of onset of pain and joint stiffness-delay in onset or
           aggravation of pain-evolution of the number of painful locations-evolution of the impact
           of pain on the quality of the sleep-consumption of permitted concomitant treatments
           (analgesics)

        -  Evolution of symptoms of hormonal deprivation-adherence to AI treatment

        -  Tolerance to AI

        -  Change seen by patients

        -  Stop rate and switch of AI-rate of recurrence of breast cancer

      Describe in patients receiving homeopathic treatment:

        -  Adherence to homeopathic treatment

        -  Tolerance to homeopathic treatment

        -  Group A: Group of patients receiving conventional treatment (drug analgesic class 1) for
           joint pain + homeopathic treatment

        -  Group B: Group of patients receiving conventional treatment (drug analgesic class 1) for
           joint pain

      Schedule :

        -  Inclusions start at: 01/09/2018

        -  End date of inclusions: 01/09/2021

        -  End date of follow-up: 23/03/2022

        -  Study report: 23/03/2023
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Evolution of the score of "most intense pain" during the first 3 months of treatment with AI
time frame: 3 months
description: Evaluation comparing between the 2 groups the area under the most intense pain curve, measured each week during the first 3 months of AI treatment using the Brief Pain Inventory-Short Form (BPI-SF) scale (1 no disconfort up to 10 complet disconfort)
measure: Evolution of joint pain
time frame: 6 months
description: variation of different pain scores on the Brief Pain Inventory-Short Form (BPI-SF) scale (1 no disconfort up to 10 complet disconfort) : pain severity score corresponding to the average of the 4 questions on pain intensity, and interference score corresponding to the average of the 7 questions on the impact of pain
measure: Rate of onset of joint pain and stiffness
time frame: 3 months
description: For pain, among patients who answered "no" to the first question of Brief Pain Inventory-Short Form (1 no disconfort up to 10 complet disconfort) to visit 1, percentage of patients who answered "Yes" to 3 months (visit 2)
measure: Rate of onset of pain and joint stiffness
time frame: 3 months
description: Percentage of patients for whom pain and / or stiffness have occurred.
measure: Time of onset or aggravation of pain
time frame: 6 months
description: time from which the "most severe pain" score has increased for at least 2 consecutive weeks since the Visit 1 score
arm group label: Groupe A with homéopathic treatment
arm group type: Active Comparator
description: Conventional treatment : paracetamol (drug analgesic class1) + Homeopathic drug : Rhus toxicodendron 9 CH et Ruta graveolens 5 CH
arm group label: Groupe B without homeopathic treatment
arm group type: Sham Comparator
description: Conventional treatment : paracetamol (drug analgesic class1)
intervention type: Drug
intervention name: Rhus toxicodendron 9 CH + Ruta graveolens 5 CH (Homeopathic Granules)
description: Rhus toxicodendron 9 CH + Ruta graveolens 5 CH
arm group label: Groupe A with homéopathic treatment
intervention type: Other
intervention name: paracetamol (drug analgesic class1)
description: paracetamol (drug analgesic class1)
arm group label: Groupe A with homéopathic treatment
arm group label: Groupe B without homeopathic treatment
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: PHILIPPE GUILBERT
role: Principal Investigator
affiliation: Institut Jean-Godinot
facility: 
country: France
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Arthralgia
mesh term: Acetaminophen
mesh term: Analgesics
sharing ipd: No