<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/NCT03791736</url>
  </required_header>
  <id_info>
    <org_study_id>2015-03</org_study_id>
    <nct_id>NCT03791736</nct_id>
  </id_info>
  <brief_title>Evaluation of Impact of Sandostatin® Injection Before Axillary Clearance on Lymphocele Formation</brief_title>
  <acronym>SANDOSTATINE</acronym>
  <official_title>Evaluation of Impact of Sandostatin® Injection Before Axillary Clearance on Lymphocele Formation In Patients With Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Cancerologie de l'Ouest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut Cancerologie de l'Ouest</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>
      The lymphocele is the main early postoperative complication of axillary clearance for breast&#xD;
      cancer patients with rates up to 85%.&#xD;
&#xD;
      The usual treatment consists of external drainage. However, this method increases the&#xD;
      duration of hospitalization.&#xD;
&#xD;
      As a result, some practitioners have abandoned drainage, allowing for ambulatory surgery.&#xD;
&#xD;
      If this solution makes it possible to reduce the duration of the hospitalizations, it&#xD;
      involves iterative punctures of the axillary hollow in case of lymphocele These punctures may&#xD;
      be responsible for pain, hematoma or infection of the operative site.&#xD;
&#xD;
      To date, no method has proved superior in terms of decreasing the incidence of lymphocele&#xD;
      postoperatively axillary clearance.&#xD;
&#xD;
      Octreotide (Sandostatin®) is a peptide, one of whose effects is to reduce the inflammation&#xD;
      responsible for lymphoceles.&#xD;
&#xD;
      The aim of the study is to inject Sandostatin® before surgery, with the aim of reducing the&#xD;
      incidence of seroma by 50% after axillary clearance&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The surgical technique is no longer used&#xD;
  </why_stopped>
  <start_date type="Actual">July 6, 2016</start_date>
  <completion_date type="Actual">July 6, 2018</completion_date>
  <primary_completion_date type="Actual">July 6, 2018</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>
    <intervention_model_description>A phase II prospective, single-center, non-randomized study.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>A 50% decrease in the incidence of lymphocele (30% to 15% progression) following axillary clearance of patients operated for breast cancer (excluding mastectomy) pretreated with an injection of Sandostatin®.</measure>
    <time_frame>6 months</time_frame>
    <description>The frequency of occurrence of a lymphocele requiring at least one evacuation puncture.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the volume of the punctures</measure>
    <time_frame>6 months</time_frame>
    <description>Determined by the volume of the punctures carried out</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the cost of this treatment</measure>
    <time_frame>6 months</time_frame>
    <description>Determined by the data recovered from the Health Insurance</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Lymphocele</condition>
  <arm_group>
    <arm_group_label>Sandostatine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Injection of Sandostatine</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Injection of sandostatine</intervention_name>
    <description>Intramuscular injection of sandostatin 30 mg 3 days before surgery</description>
    <arm_group_label>Sandostatine</arm_group_label>
    <other_name>Octreotide</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Breast cancer, histologically proven Axillary clearance Elective axillary approach Age ≥ 18&#xD;
        years OMS &lt; 3 Normal hematological and hepatic blood tests Obtaining the signed written&#xD;
        consent of the patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Axillary clearance with a mastectomy Metastatic disease Disorder precluding understanding&#xD;
        of trial information or informed consent Pregnancy, breastfeeding women Patient is willing&#xD;
        and able to comply with the protocol for the duration of the study including all scheduled&#xD;
        treatment, visits and examinations No severe or uncontrolled diabetes Known&#xD;
        hypersensitivity to Octreotide Patient with vitamin B12 deficiency Anticoagulant treatment&#xD;
        History of cardiovascular disease Other product being tested in the 4 weeks prior to the&#xD;
        start of treatment Patient has valid health insurance&#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>EMMANUELLE MARTIN, MD</last_name>
    <role>Study Director</role>
    <affiliation>INSTITUT DE CANCEROLOGIE DE L'OUEST</affiliation>
  </overall_official>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>December 31, 2018</study_first_submitted>
  <study_first_submitted_qc>December 31, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>July 26, 2022</last_update_submitted>
  <last_update_submitted_qc>July 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>breast cancer</keyword>
  <keyword>axillary clearance</keyword>
  <keyword>lymphocele</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Lymphocele</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Octreotide</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/NCT03791736
org study id: 2015-03
nct id: NCT03791736
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The lymphocele is the main early postoperative complication of axillary clearance for breast
      cancer patients with rates up to 85%.

      The usual treatment consists of external drainage. However, this method increases the
      duration of hospitalization.

      As a result, some practitioners have abandoned drainage, allowing for ambulatory surgery.

      If this solution makes it possible to reduce the duration of the hospitalizations, it
      involves iterative punctures of the axillary hollow in case of lymphocele These punctures may
      be responsible for pain, hematoma or infection of the operative site.

      To date, no method has proved superior in terms of decreasing the incidence of lymphocele
      postoperatively axillary clearance.

      Octreotide (Sandostatin®) is a peptide, one of whose effects is to reduce the inflammation
      responsible for lymphoceles.

      The aim of the study is to inject Sandostatin® before surgery, with the aim of reducing the
      incidence of seroma by 50% after axillary clearance
allocation: N/A
intervention model: Single Group Assignment
intervention model description: A phase II prospective, single-center, non-randomized study.
primary purpose: Prevention
masking: None (Open Label)
measure: A 50% decrease in the incidence of lymphocele (30% to 15% progression) following axillary clearance of patients operated for breast cancer (excluding mastectomy) pretreated with an injection of Sandostatin®.
time frame: 6 months
description: The frequency of occurrence of a lymphocele requiring at least one evacuation puncture.
measure: Evaluation of the volume of the punctures
time frame: 6 months
description: Determined by the volume of the punctures carried out
measure: Evaluation of the cost of this treatment
time frame: 6 months
description: Determined by the data recovered from the Health Insurance
arm group label: Sandostatine
arm group type: Experimental
description: Injection of Sandostatine
intervention type: Procedure
intervention name: Injection of sandostatine
description: Intramuscular injection of sandostatin 30 mg 3 days before surgery
arm group label: Sandostatine
other name: Octreotide
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: EMMANUELLE MARTIN, MD
role: Study Director
affiliation: INSTITUT DE CANCEROLOGIE DE L'OUEST
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Lymphocele
mesh term: Octreotide
sharing ipd: No