<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/NCT03797248</url>
  </required_header>
  <id_info>
    <org_study_id>201801559A3</org_study_id>
    <nct_id>NCT03797248</nct_id>
  </id_info>
  <brief_title>Prospective Cohort Study of Traditional Chinese Medicine for Survival of Patients With Early Breast Cancer</brief_title>
  <official_title>The Clinical Outcome of Adjuvant Chemotherapy in Conjunction With Traditional Chinese Medicine in Breast Cancer Patients -a Observational Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This 2-year trial is intended to be used to study breast cancer patients through&#xD;
      forward-looking generation design through collaboration between Chinese and Western medical&#xD;
      teams. The whole study consists of 2 stages, stage I comprises a cross-sectional&#xD;
      study-baseline and stage II is a cohort for outcome evaluation and follow-up study across a&#xD;
      3-year period. To provide an empirical basis for combined TCM treatment in the Breast Cancer&#xD;
      Research Team and to publish that as a reference for future TCM and Western medicine in&#xD;
      integrative cancer treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Breast cancer is a major health issue for women worldwide and has increased exponentially in&#xD;
      the last decades. Improved earlier detection combined with adjuvant systemic therapy is&#xD;
      responsible for much of the reduction in cause-specific mortality from breast cancer.&#xD;
      Chemotherapy after surgery can decrease the risk of recurrence and is often used as routine&#xD;
      treatment in clinic. Because of the fact that a considerable number of patients seek for&#xD;
      traditional Chinese medicine (TCM) during adjuvant chemotherapy, it is thus need to evaluate&#xD;
      the correlation between TCM treatment and prognosis. The investigators design a single&#xD;
      center, prospective cohort study began in November 2018 in Kaohsiung, Taiwan. A sample of 104&#xD;
      participants diagnosed with early breast cancer was recruited from Breast Cancer Research&#xD;
      Team and are followed up every 3 to 6 months till October 2023. Detailed information of&#xD;
      participants includes general information, history of cancer, quality of life, side effects&#xD;
      of chemotherapy and safety of treatment, body constitution of TCM and meridian energy&#xD;
      analysis is taken face-to-face at baseline.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 12, 2018</start_date>
  <completion_date type="Anticipated">October 24, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 24, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>disease-free survival</measure>
    <time_frame>3 years</time_frame>
    <description>3-year disease-free survival</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>QOLs measurement-1</measure>
    <time_frame>6 months</time_frame>
    <description>Functional Assessment of Cancer Therapy - Breast Cancer(FACT-B)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QOLs measurement-2</measure>
    <time_frame>6 months</time_frame>
    <description>Eastern Cooperative Oncology Group (ECOG)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TCM pattern</measure>
    <time_frame>6 months</time_frame>
    <description>Body Constitution Questionnaire (BCQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>meridian energy</measure>
    <time_frame>6 months</time_frame>
    <description>Meridian Energy Analysis Device (MEAD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effects of adjuvant chemotherapy</measure>
    <time_frame>6 months</time_frame>
    <description>Common Terminology Criteria for Adverse Events (CTCAE)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">310</enrollment>
  <condition>Early-stage Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <description>adjuvant chemotherapy combined with Chinese herbal medicine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2</arm_group_label>
    <description>adjuvant chemotherapy only</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Chinese herbal medicine</intervention_name>
    <description>All Chinese herbal products prescribed from TCM physicians in our hospital during patients receiving adjuvant chemotherapy</description>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_label>Cohort 2</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with breast cancer aged over 20 years with histologically diagnosed stage 1-3&#xD;
        after radical surgery are enrolled from an academic medical center. All participants need&#xD;
        to complete the 6-8 cycle of adjuvant chemotherapy, which may last 6 months.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged &gt; 20 years old female patients;&#xD;
&#xD;
          -  Patients with histologically proven stage 1-3 breast cancer after surgery;&#xD;
&#xD;
          -  The duration from the end of radical surgery to the beginning of the trail is less&#xD;
             than 1 month;&#xD;
&#xD;
          -  ECOG score is 0-2 points;&#xD;
&#xD;
          -  Agreed to participate in this study and signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Combined with inadequate heart, liver, kidney and hematopoietic function and other&#xD;
             serious diseases;&#xD;
&#xD;
          -  Pregnant and lactating women;&#xD;
&#xD;
          -  Patients with a history of mental illness;&#xD;
&#xD;
          -  Patients with distant metastasis and/or expected lifetime less than 3 months;&#xD;
&#xD;
          -  Patients undergoing other medicinal herbs outside our hospital.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chien-Ting Liu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Oncology, Department of Internal Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ming-Yen Tsai, PhD</last_name>
    <phone>+886975056534</phone>
    <email>missuriae@yahoo.com.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kaohsiung Chang Gung Memorial Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>83301</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ming-Yen Tsai</last_name>
      <phone>+886975056534</phone>
      <phone_ext>+886975056534</phone_ext>
      <email>missuriae@yahoo.com.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>January 5, 2019</study_first_submitted>
  <study_first_submitted_qc>January 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>September 15, 2019</last_update_submitted>
  <last_update_submitted_qc>September 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chang Gung Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Ming-Yen Tsai</investigator_full_name>
    <investigator_title>Department of Chinese medicine</investigator_title>
  </responsible_party>
  <keyword>traditional Chinese medicine</keyword>
  <keyword>quality of life</keyword>
  <keyword>disease-free survival</keyword>
  <keyword>adjuvant chemotherapy</keyword>
  <keyword>breast cancer</keyword>
  <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>
    <ipd_description>The datasets during and/or analyzed during the current study available from the corresponding author on reasonable request.</ipd_description>
  </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/NCT03797248
org study id: 201801559A3
nct id: NCT03797248
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This 2-year trial is intended to be used to study breast cancer patients through
      forward-looking generation design through collaboration between Chinese and Western medical
      teams. The whole study consists of 2 stages, stage I comprises a cross-sectional
      study-baseline and stage II is a cohort for outcome evaluation and follow-up study across a
      3-year period. To provide an empirical basis for combined TCM treatment in the Breast Cancer
      Research Team and to publish that as a reference for future TCM and Western medicine in
      integrative cancer treatment.
Breast cancer is a major health issue for women worldwide and has increased exponentially in
      the last decades. Improved earlier detection combined with adjuvant systemic therapy is
      responsible for much of the reduction in cause-specific mortality from breast cancer.
      Chemotherapy after surgery can decrease the risk of recurrence and is often used as routine
      treatment in clinic. Because of the fact that a considerable number of patients seek for
      traditional Chinese medicine (TCM) during adjuvant chemotherapy, it is thus need to evaluate
      the correlation between TCM treatment and prognosis. The investigators design a single
      center, prospective cohort study began in November 2018 in Kaohsiung, Taiwan. A sample of 104
      participants diagnosed with early breast cancer was recruited from Breast Cancer Research
      Team and are followed up every 3 to 6 months till October 2023. Detailed information of
      participants includes general information, history of cancer, quality of life, side effects
      of chemotherapy and safety of treatment, body constitution of TCM and meridian energy
      analysis is taken face-to-face at baseline.
observational model: Cohort
time perspective: Prospective
measure: disease-free survival
time frame: 3 years
description: 3-year disease-free survival
measure: QOLs measurement-1
time frame: 6 months
description: Functional Assessment of Cancer Therapy - Breast Cancer(FACT-B)
measure: QOLs measurement-2
time frame: 6 months
description: Eastern Cooperative Oncology Group (ECOG)
measure: TCM pattern
time frame: 6 months
description: Body Constitution Questionnaire (BCQ)
measure: meridian energy
time frame: 6 months
description: Meridian Energy Analysis Device (MEAD)
measure: Side effects of adjuvant chemotherapy
time frame: 6 months
description: Common Terminology Criteria for Adverse Events (CTCAE)
arm group label: Cohort 1
description: adjuvant chemotherapy combined with Chinese herbal medicine
arm group label: Cohort 2
description: adjuvant chemotherapy only
intervention type: Combination Product
intervention name: Chinese herbal medicine
description: All Chinese herbal products prescribed from TCM physicians in our hospital during patients receiving adjuvant chemotherapy
arm group label: Cohort 1
arm group label: Cohort 2
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Chien-Ting Liu, MD
role: Principal Investigator
affiliation: Division of Oncology, Department of Internal Medicine
last name: Ming-Yen Tsai, PhD
phone: +886975056534
email: missuriae@yahoo.com.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Chang Gung Memorial Hospital
investigator full name: Ming-Yen Tsai
investigator title: Department of Chinese medicine
mesh term: Breast Neoplasms
sharing ipd: No
ipd description: The datasets during and/or analyzed during the current study available from the corresponding author on reasonable request.