<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/NCT03250130</url>
  </required_header>
  <id_info>
    <org_study_id>ICM-URC-2014/ 31</org_study_id>
    <nct_id>NCT03250130</nct_id>
  </id_info>
  <brief_title>Hypnosis for Patients Treated With Adjuvant Chemotherapy for Breast Cancer(HYPNOVAL)</brief_title>
  <acronym>HYPNOVAL</acronym>
  <official_title>Medical Ericksonian Hypnosis on Patients Treated With Adjuvant Chemotherapy for Breast Cancer at the ICM Val d'Aurelle - Montpellier: a Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut du Cancer de Montpellier - Val d'Aurelle</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut du Cancer de Montpellier - Val d'Aurelle</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective is to assess the feasibility of an intervention based on medical&#xD;
      Ericksonian hypnosis as a complementary therapy in patients treated with surgery after a&#xD;
      diagnosis of breast cancer, followed by an indication of adjuvant chemotherapy and&#xD;
      radiotherapy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the field of management of cancer, many approaches have been used since tens of years,&#xD;
      particularly in regard of pain management, both in achieving surgical or invasive procedures&#xD;
      in the pain induced by the disease itself. the investigators owe the first description in&#xD;
      1829 Chapelin and col who used hypnosis in a patient with breast cancer in which a mastectomy&#xD;
      should be performed. Meta-analysis (2000) showed the positive impact of analgesia obtained&#xD;
      through hypnosis on the perception of pain intensity. In children in whom regular venous&#xD;
      punctures is performed, using hypnosis seems indisputable on the management of anticipatory&#xD;
      anxiety, leading to a better experience of the act itself. Regarding the nausea and vomiting&#xD;
      induced by chemotherapy, numerous studies are old, not always randomized and performed often&#xD;
      before the era of the setrons; but seems favorable impact on anticipated nausea and vomiting,&#xD;
      the updated studies should emerge on the issue of delayed emesis which remain a serious&#xD;
      adverse event and not completely resolved. Mark to improve the EORTC validated tools of&#xD;
      quality of life measurement widely used for example in ovarian cancer.&#xD;
&#xD;
      The impact of hypnosis on the quality of life or the side effects of treatment or&#xD;
      rehospitalization for toxicity remains controversial (Judson, 2011). A meta-analysis&#xD;
      combining the tests carried out before and after the era of setrons (Richardson, 2007)&#xD;
      concluded that the effectiveness of the anticipated nausea and vomiting.&#xD;
&#xD;
      In this context,the investigators proposed to conduct a feasibility study to evaluate the&#xD;
      role and impact of medical Ericksonian hypnosis on acute and delayed adverse event (incl&#xD;
      nausea and vomiting) in female patients treated by adjuvant chemotherapy for breast cancer.&#xD;
&#xD;
      The main objective is to assess the feasibility of an intervention based on medical&#xD;
      Ericksonian hypnosis as a complementary therapy in patients treated with surgery after a&#xD;
      diagnosis of breast cancer, followed by an indication of adjuvant chemotherapy and&#xD;
      radiotherapy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2015</start_date>
  <completion_date type="Actual">June 6, 2017</completion_date>
  <primary_completion_date type="Actual">September 1, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>proportion of patients rated as being compliant to self-hypnosis</measure>
    <time_frame>through study completion, an average of 2 years</time_frame>
    <description>The main objective is to assess the feasibility of an intervention based on medical Ericksonian hypnosis as a complementary therapy in patients treated with surgery after a diagnosis of breast cancer, followed by an indication of adjuvant chemotherapy and radiotherapy.&#xD;
Primary endpoint is the proportion of patients rated as being compliant to self-hypnosis sessions during adjuvant chemotherapy (6 sessions). A patient is considered as compliant if it achieves at least 2/3 of the planned self-hypnosis sessions, that is, 4 of 6 planned sessions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impact of hypnosis on the tolerance of the CT</measure>
    <time_frame>through study completion, an average of 2 years</time_frame>
    <description>The secondary objective is to describe its impact on the tolerance of the CT</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Hypnosis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patient achieve self-hypnosis sessions in these chemotherapy treatments</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>hypnosis</intervention_name>
    <description>The patient achieve self-hypnosis sessions in these chemotherapy treatments</description>
    <arm_group_label>Hypnosis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Female, age &gt; 18 years-old&#xD;
&#xD;
               -  Without previous practice of hypnosis&#xD;
&#xD;
               -  Patient with diagnosis of breast cancer&#xD;
&#xD;
               -  Patient receiving an adjuvant chemotherapy for at least 3 months with an&#xD;
                  indication of radiotherapy after chemotherapy&#xD;
&#xD;
               -  Patient accepting the principle of the study with a signed written informed&#xD;
                  consent&#xD;
&#xD;
               -  Patient affiliated to French Social Security&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Male&#xD;
&#xD;
               -  Age &lt; 18 years&#xD;
&#xD;
               -  Patient refusing hypnosis&#xD;
&#xD;
               -  Pregnancy, breast-feeding, or lack of effective contraception in female patients&#xD;
                  with reproductive potential.&#xD;
&#xD;
               -  Patient with psychological or mental disorders under psychotropic treatments&#xD;
                  (lithium, neuroleptics)&#xD;
&#xD;
               -  Not ability to speak and read French, deaf and/or mute&#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>Michel FABBRO</last_name>
    <role>Study Chair</role>
    <affiliation>Institut régional du Cancer de Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut régional du Cancer de montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34298</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 29, 2016</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>August 7, 2020</last_update_submitted>
  <last_update_submitted_qc>August 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2020</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>
  </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/NCT03250130
org study id: ICM-URC-2014/ 31
nct id: NCT03250130
lead sponsor: 
has dmc: No
The main objective is to assess the feasibility of an intervention based on medical
      Ericksonian hypnosis as a complementary therapy in patients treated with surgery after a
      diagnosis of breast cancer, followed by an indication of adjuvant chemotherapy and
      radiotherapy
In the field of management of cancer, many approaches have been used since tens of years,
      particularly in regard of pain management, both in achieving surgical or invasive procedures
      in the pain induced by the disease itself. the investigators owe the first description in
      1829 Chapelin and col who used hypnosis in a patient with breast cancer in which a mastectomy
      should be performed. Meta-analysis (2000) showed the positive impact of analgesia obtained
      through hypnosis on the perception of pain intensity. In children in whom regular venous
      punctures is performed, using hypnosis seems indisputable on the management of anticipatory
      anxiety, leading to a better experience of the act itself. Regarding the nausea and vomiting
      induced by chemotherapy, numerous studies are old, not always randomized and performed often
      before the era of the setrons; but seems favorable impact on anticipated nausea and vomiting,
      the updated studies should emerge on the issue of delayed emesis which remain a serious
      adverse event and not completely resolved. Mark to improve the EORTC validated tools of
      quality of life measurement widely used for example in ovarian cancer.

      The impact of hypnosis on the quality of life or the side effects of treatment or
      rehospitalization for toxicity remains controversial (Judson, 2011). A meta-analysis
      combining the tests carried out before and after the era of setrons (Richardson, 2007)
      concluded that the effectiveness of the anticipated nausea and vomiting.

      In this context,the investigators proposed to conduct a feasibility study to evaluate the
      role and impact of medical Ericksonian hypnosis on acute and delayed adverse event (incl
      nausea and vomiting) in female patients treated by adjuvant chemotherapy for breast cancer.

      The main objective is to assess the feasibility of an intervention based on medical
      Ericksonian hypnosis as a complementary therapy in patients treated with surgery after a
      diagnosis of breast cancer, followed by an indication of adjuvant chemotherapy and
      radiotherapy
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: proportion of patients rated as being compliant to self-hypnosis
time frame: through study completion, an average of 2 years
description: The main objective is to assess the feasibility of an intervention based on medical Ericksonian hypnosis as a complementary therapy in patients treated with surgery after a diagnosis of breast cancer, followed by an indication of adjuvant chemotherapy and radiotherapy.
Primary endpoint is the proportion of patients rated as being compliant to self-hypnosis sessions during adjuvant chemotherapy (6 sessions). A patient is considered as compliant if it achieves at least 2/3 of the planned self-hypnosis sessions, that is, 4 of 6 planned sessions.
measure: Impact of hypnosis on the tolerance of the CT
time frame: through study completion, an average of 2 years
description: The secondary objective is to describe its impact on the tolerance of the CT
arm group label: Hypnosis
arm group type: Experimental
description: The patient achieve self-hypnosis sessions in these chemotherapy treatments
intervention type: Behavioral
intervention name: hypnosis
description: The patient achieve self-hypnosis sessions in these chemotherapy treatments
arm group label: Hypnosis
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michel FABBRO
role: Study Chair
affiliation: Institut régional du Cancer de Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No