<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/NCT02981485</url>
  </required_header>
  <id_info>
    <org_study_id>CZ2015009</org_study_id>
    <nct_id>NCT02981485</nct_id>
  </id_info>
  <brief_title>Fat Grafting Used for the Treatment of Breast Cancer Related Lymphedema in China</brief_title>
  <acronym>FGTBRCL</acronym>
  <official_title>Fat Grafting Used for the Treatment of Breast Cancer Related Lymphedema in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Breast cancer related lymphedema (BRCL) is a common complication following breast cancer&#xD;
      treatment. The incidence of BRCL ranges from 6-50%, depending on the surgical procedure in&#xD;
      the axilla and the type of the radiation therapy. BRCL can causes cosmetic deformities,&#xD;
      impaired physical mobility, mental discomfort, reduced quality of life and erysipelas.&#xD;
      Therapy of BRCL is divided into conservative and operative methods. However, all the above&#xD;
      method has some shortcomings. It is urgent to investigate new approaches to treat BRCL. In&#xD;
      this study, fat grafting is to be used for the treatment of BRCL, and the efficacy and safety&#xD;
      of this method will be also assessed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">January 2019</completion_date>
  <primary_completion_date type="Anticipated">January 2018</primary_completion_date>
  <phase>Phase 2</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in arm volume</measure>
    <time_frame>Baseline, 3 months, 6months and 12 months</time_frame>
    <description>All the patients who received treatment are scanned by 3 dimensional camera, then the volume measurement of the affected and normal arm is managed by software</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in tissue edema</measure>
    <time_frame>Baseline, 3 months, 6months and 12 months</time_frame>
    <description>The affected and normal arms of the patients who received treatment are assessed by multi-frequency bioelectrical impedance analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The function of the lymphatic vessel</measure>
    <time_frame>Baseline, 3 months, 6months and 12 months</time_frame>
    <description>The affected arms of the patients who received treatment was assessed by indocyanine green lymphography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effects of treatment</measure>
    <time_frame>Baseline, 3 months, 6months and 12 months</time_frame>
    <description>Any side effects of experimental treatment. The patients who received treatment are asked at each visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>The patients who received treatment are asked to fill in a questionnaire (EQ-5D- 5 L-questionnaire)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Breast Cancer Lymphedema</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment of breast cancer related lymphedema by fat grafting</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fat Grafting</intervention_name>
    <description>Treatment of breast cancer related lymphedema by fat grafting</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Breast cancer diagnosis regardless of the date of operation and identified unilateral arm&#xD;
        lymphedema Stage Ⅱ of lymphedema according to the standard of International Society of&#xD;
        Lymphology The patient is able to read, understand, and complete questionnaires. Completed&#xD;
        radiotherapy and/or chemotherapy at least 2 months prior to inclusion The patient&#xD;
        understands the nature and purpose of this study and the study procedures and has signed&#xD;
        informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Relapse of breast cancer Untreated infection Untreated heart failure Untreated renal&#xD;
        failure Untreated deep venous thrombosis in the arm Iodine allergy Pregnancy Psychiatric&#xD;
        disorders&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jie Luan, MD</last_name>
    <role>Study Director</role>
    <affiliation>Plastic Surgery Hospital of Chinese Academy of Medical Sciences, Peking Union Medical College</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Minqiang Xin, MD</last_name>
    <phone>+86 10 88772340</phone>
    <email>doctorshin@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Chenglong Wang, MD</last_name>
    <phone>+86 10 88772076</phone>
    <email>likexfz@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Plastic Surgery Hospital of Chinese Academy of Medical Sciences, Peking Union Medical College</name>
      <address>
        <city>Shijingshan</city>
        <state>Beijing</state>
        <zip>100144</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chenglong Wang, MD</last_name>
    </contact>
    <investigator>
      <last_name>Minqiang Xin, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>December 3, 2016</last_update_submitted>
  <last_update_submitted_qc>December 3, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 6, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking Union Medical College</investigator_affiliation>
    <investigator_full_name>Minqiang Xin</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Fat Grafting, Breast Cancer Lymphedema</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Lymphedema</mesh_term>
    <mesh_term>Breast Cancer Lymphedema</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/NCT02981485
org study id: CZ2015009
nct id: NCT02981485
lead sponsor: 
has dmc: Yes
Breast cancer related lymphedema (BRCL) is a common complication following breast cancer
      treatment. The incidence of BRCL ranges from 6-50%, depending on the surgical procedure in
      the axilla and the type of the radiation therapy. BRCL can causes cosmetic deformities,
      impaired physical mobility, mental discomfort, reduced quality of life and erysipelas.
      Therapy of BRCL is divided into conservative and operative methods. However, all the above
      method has some shortcomings. It is urgent to investigate new approaches to treat BRCL. In
      this study, fat grafting is to be used for the treatment of BRCL, and the efficacy and safety
      of this method will be also assessed.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in arm volume
time frame: Baseline, 3 months, 6months and 12 months
description: All the patients who received treatment are scanned by 3 dimensional camera, then the volume measurement of the affected and normal arm is managed by software
measure: Change in tissue edema
time frame: Baseline, 3 months, 6months and 12 months
description: The affected and normal arms of the patients who received treatment are assessed by multi-frequency bioelectrical impedance analysis
measure: The function of the lymphatic vessel
time frame: Baseline, 3 months, 6months and 12 months
description: The affected arms of the patients who received treatment was assessed by indocyanine green lymphography
measure: Side effects of treatment
time frame: Baseline, 3 months, 6months and 12 months
description: Any side effects of experimental treatment. The patients who received treatment are asked at each visit
measure: Change in quality of life
time frame: Baseline and 12 months
description: The patients who received treatment are asked to fill in a questionnaire (EQ-5D- 5 L-questionnaire)
arm group label: Experimental
arm group type: Experimental
description: Treatment of breast cancer related lymphedema by fat grafting
intervention type: Device
intervention name: Fat Grafting
description: Treatment of breast cancer related lymphedema by fat grafting
arm group label: Experimental
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: No
last name: Jie Luan, MD
role: Study Director
affiliation: Plastic Surgery Hospital of Chinese Academy of Medical Sciences, Peking Union Medical College
last name: Minqiang Xin, MD
phone: +86 10 88772340
email: doctorshin@163.com
last name: Chenglong Wang, MD
phone: +86 10 88772076
email: likexfz@126.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking Union Medical College
investigator full name: Minqiang Xin
investigator title: Principal Investigator
mesh term: Breast Neoplasms
mesh term: Lymphedema
mesh term: Breast Cancer Lymphedema
sharing ipd: No