<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/NCT01727362</url>
  </required_header>
  <id_info>
    <org_study_id>ACU in breast cancer</org_study_id>
    <nct_id>NCT01727362</nct_id>
  </id_info>
  <brief_title>Evaluation of Effectiveness of Acupuncture on Quality of Life in Patients With Breast Cancer Receiving Chemotherapy</brief_title>
  <official_title>Evaluation of Effectiveness of Acupuncture on Quality of Life in Patients With Breast Cancer Receiving Chemotherapy- A Pragmatic Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mammazentrum Hamburg am Krankenhaus Jerusalem, Germany</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dorit und Alexander Otto Stiftung, Hamburg, Germany</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this trial is to investigate the effectiveness of acupuncture on quality of life&#xD;
      in patients with breast cancer receiving chemotherapy compared to routine care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At the Mammazentrum Hamburg, Germany, patients with breast cancer receiving chemotherapy have&#xD;
      the opportunity to get acupuncture in addition to conventional therapy to maintain quality of&#xD;
      life and to reduce the side effects of the chemotherapy such as gastrointestinal disorders.&#xD;
      In this randomized trial we aim to investigate the effectiveness of additional acupuncture&#xD;
      compared to routine care in patients with breast cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)</measure>
    <time_frame>6 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)</measure>
    <time_frame>3 month</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Subscales of the Functional Assessment of Cancer Therapy - General (FACT-G): physical well-being, social/family well-being, emotional well-being, functional well-being</measure>
    <time_frame>3 month</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Subscales of the Functional Assessment of Cancer Therapy - General (FACT-G): physical well-being, social/family well-being, emotional well-being, functional well-being</measure>
    <time_frame>6 month</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Subscale for Breast Cancer of the Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)</measure>
    <time_frame>3 month</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Subscale for Breast Cancer of the Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)</measure>
    <time_frame>6 month</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Pain, quality of sleep, and nausea (single items of the FACT-B)</measure>
    <time_frame>3 month</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Pain, quality of sleep, and nausea (single items of the FACT-B)</measure>
    <time_frame>6 month</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Functional Assessment of Chronic Illness Therapy-Fatigue</measure>
    <time_frame>3 month</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Functional Assessment of Chronic Illness Therapy-Fatigue</measure>
    <time_frame>6 month</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>FACT/GOG-NTX, polyneuropathy symptoms</measure>
    <time_frame>3 month</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>FACT/GOG-NTX, polyneuropathy symptoms</measure>
    <time_frame>6 month</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Quality of Life (SF-12 Health Survey)</measure>
    <time_frame>3 month</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Quality of Life (SF-12 Health Survey)</measure>
    <time_frame>6 month</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Survival without relapse</measure>
    <time_frame>6 month</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Survival</measure>
    <time_frame>6 month</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Adverse effects and Interactions</measure>
    <time_frame>3 month</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Adverse effects and Interactions</measure>
    <time_frame>6 month</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Satisfaction and patient-reported effectiveness</measure>
    <time_frame>3 month</time_frame>
    <description>This will only be assessed in the acupuncture arm</description>
  </other_outcome>
  <other_outcome>
    <measure>Satisfaction and patient-reported effectiveness</measure>
    <time_frame>6 month</time_frame>
    <description>This will only be assessed in the acupuncture arm</description>
  </other_outcome>
  <other_outcome>
    <measure>Goal Attainment Scale</measure>
    <time_frame>3 month</time_frame>
    <description>This will only be assessed in the acupuncture arm</description>
  </other_outcome>
  <other_outcome>
    <measure>Goal Attainment Scale</measure>
    <time_frame>6 month</time_frame>
    <description>This will only be assessed in the acupuncture arm</description>
  </other_outcome>
  <other_outcome>
    <measure>Laboratory parameters (hemoglobin, leukocytes, blood plates, liver values, kidney values)</measure>
    <time_frame>3 month</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Laboratory parameters (hemoglobin, leukocytes, blood plates, liver values, kidney values)</measure>
    <time_frame>6 month</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Usual care + acupuncture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care + acupuncture</intervention_name>
    <description>Patients of this group receive a semi-standardized acupuncture treatment over 6 month in addition to usual care</description>
    <arm_group_label>Usual care + acupuncture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <description>Patients of this group receive usual care only</description>
    <arm_group_label>Usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosed breast cancer (invasive, intraductal, hormone-sensitive and not&#xD;
             hormone-sensitive, only locoregional metastases)&#xD;
&#xD;
          -  current chemotherapy at Mammazentrum Hamburg with regimen FEC/DOC or EC/DOC&#xD;
&#xD;
          -  willingness to receive acupuncture within the next 6 month if randomized in&#xD;
             acupuncture group&#xD;
&#xD;
          -  willingness to refrain from acupuncture within the next 6 month if randomized in&#xD;
             control group&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  distant metastases&#xD;
&#xD;
          -  blood coagulation disorder and/or current use of anticoagulants&#xD;
&#xD;
          -  serious acute or chronic mental or physical disorders&#xD;
&#xD;
          -  clinically relevant cardiac arrhythmia symptoms&#xD;
&#xD;
          -  insufficient German language ability&#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>Martin Carstensen, Prof. MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mammazentrum am Krankenhaus Jerusalem, Hamburg, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mammazentrum Hamburg am Krankenhaus Jerusalem</name>
      <address>
        <city>Hamburg</city>
        <zip>20357</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>November 7, 2012</study_first_submitted>
  <study_first_submitted_qc>November 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <last_update_submitted>July 21, 2017</last_update_submitted>
  <last_update_submitted_qc>July 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Claudia M. Witt</investigator_full_name>
    <investigator_title>Professor, MD</investigator_title>
  </responsible_party>
  <keyword>Breast Cancer</keyword>
  <keyword>Acupuncture</keyword>
  <keyword>Quality of Life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT01727362
org study id: ACU in breast cancer
nct id: NCT01727362
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The aim of this trial is to investigate the effectiveness of acupuncture on quality of life
      in patients with breast cancer receiving chemotherapy compared to routine care.
At the Mammazentrum Hamburg, Germany, patients with breast cancer receiving chemotherapy have
      the opportunity to get acupuncture in addition to conventional therapy to maintain quality of
      life and to reduce the side effects of the chemotherapy such as gastrointestinal disorders.
      In this randomized trial we aim to investigate the effectiveness of additional acupuncture
      compared to routine care in patients with breast cancer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
time frame: 6 month
measure: Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
time frame: 3 month
measure: Subscales of the Functional Assessment of Cancer Therapy - General (FACT-G): physical well-being, social/family well-being, emotional well-being, functional well-being
time frame: 3 month
measure: Subscales of the Functional Assessment of Cancer Therapy - General (FACT-G): physical well-being, social/family well-being, emotional well-being, functional well-being
time frame: 6 month
measure: Subscale for Breast Cancer of the Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
time frame: 3 month
measure: Subscale for Breast Cancer of the Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
time frame: 6 month
measure: Pain, quality of sleep, and nausea (single items of the FACT-B)
time frame: 3 month
measure: Pain, quality of sleep, and nausea (single items of the FACT-B)
time frame: 6 month
measure: Functional Assessment of Chronic Illness Therapy-Fatigue
time frame: 3 month
measure: Functional Assessment of Chronic Illness Therapy-Fatigue
time frame: 6 month
measure: FACT/GOG-NTX, polyneuropathy symptoms
time frame: 3 month
measure: FACT/GOG-NTX, polyneuropathy symptoms
time frame: 6 month
measure: Quality of Life (SF-12 Health Survey)
time frame: 3 month
measure: Quality of Life (SF-12 Health Survey)
time frame: 6 month
measure: Survival without relapse
time frame: 6 month
measure: Survival
time frame: 6 month
measure: Adverse effects and Interactions
time frame: 3 month
measure: Adverse effects and Interactions
time frame: 6 month
measure: Satisfaction and patient-reported effectiveness
time frame: 3 month
description: This will only be assessed in the acupuncture arm
measure: Satisfaction and patient-reported effectiveness
time frame: 6 month
description: This will only be assessed in the acupuncture arm
measure: Goal Attainment Scale
time frame: 3 month
description: This will only be assessed in the acupuncture arm
measure: Goal Attainment Scale
time frame: 6 month
description: This will only be assessed in the acupuncture arm
measure: Laboratory parameters (hemoglobin, leukocytes, blood plates, liver values, kidney values)
time frame: 3 month
measure: Laboratory parameters (hemoglobin, leukocytes, blood plates, liver values, kidney values)
time frame: 6 month
arm group label: Usual care + acupuncture
arm group type: Active Comparator
arm group label: Usual care
arm group type: Active Comparator
intervention type: Other
intervention name: Usual care + acupuncture
description: Patients of this group receive a semi-standardized acupuncture treatment over 6 month in addition to usual care
arm group label: Usual care + acupuncture
intervention type: Other
intervention name: Usual care
description: Patients of this group receive usual care only
arm group label: Usual care
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Martin Carstensen, Prof. MD
role: Principal Investigator
affiliation: Mammazentrum am Krankenhaus Jerusalem, Hamburg, Germany
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Claudia M. Witt
investigator title: Professor, MD
mesh term: Breast Neoplasms