<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/NCT02243163</url>
  </required_header>
  <id_info>
    <org_study_id>1020106</org_study_id>
    <nct_id>NCT02243163</nct_id>
  </id_info>
  <brief_title>Effect of Yoga on Life Quality and Immunity in Breast Cancer Patients After Operation and or Chemotherapy</brief_title>
  <official_title>Effect of Yoga on Life Quality and Immunity in Breast Cancer Patients After Operation and or Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Bing Show Chwan Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Bing Show Chwan Memorial Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of study is to investigate if yoga exercise improve life quality and immune&#xD;
      status in breast cancer patients after complete treatment (including surgery and / or&#xD;
      radiotherapy and / or chemotherapy)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is well-known that exercise promote immune regulation for better life quality. However,&#xD;
      the mechanism for better immunity and life quality is not clear. We postulate that Ayurveda&#xD;
      yoga might benefit breast cancer women with completion of operation and/or chemotherapy and&#xD;
      radiotherapy. The benefits could be due to immune modulation, and improve health perception&#xD;
      and life quality, and even potential decrease of cancer relapse.&#xD;
&#xD;
      The study patients will do yoga twice a week for 12 weeks. The study primary endpoints are 1)&#xD;
      to improve personal health perception, 2) to improve life quality and 3) to enhance human&#xD;
      immunity. The study secondary endpoint will follow up the immunity changes 3 months after the&#xD;
      intervention.&#xD;
&#xD;
      We anticipate to reach the primary endpoints and to publish the primary results in one year,&#xD;
      the secondary endpoint will complete in the second year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2014</start_date>
  <completion_date type="Anticipated">April 2015</completion_date>
  <primary_completion_date type="Anticipated">April 2015</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>Basic Science</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improve personal health and life quality</measure>
    <time_frame>Change from baseline in personal health and life quality at 6 months.</time_frame>
    <description>Health and life quality will assessed by modified fatigue inventory and EORTC QLQ-C30 (version 3) at three different times: (1)baseline data: before yoga exercise, (2)outcome data: at 6 and 12 weeks post-test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Immune modulation</measure>
    <time_frame>Change from baseline in human immunity at 3 months.</time_frame>
    <description>Lymphocytes will be extracted from peripheral blood for analyses of lymphocytes subpopulation (Th1/ Th2/ Treg/ Th17), polarization (T-bet/ Gata-3/ Foxp3/ RORrt) and its related cytokines (Th1: IL-12/ IFN-γ/ IL-27; Th2: IL-4/ IL-13/ IL-25; Th17: IL-17A/ IL-6/ IL-21; Treg: TGF/ IL-10. Saliva collection for analyses of cortisol and IL-6 at 3 different times: (1) baseline data: before yoga exercise, (2)outcome data: at 6 and 12 weeks post-test.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Female Breast Carcinoma</condition>
  <arm_group>
    <arm_group_label>Yoga exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive regular 90-minutes yoga classes twice a week for 3 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Yoga exercise</intervention_name>
    <description>Subjects will receive regular 90-minutes yoga classes twice a week for 3 months.</description>
    <arm_group_label>Yoga exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to attend yoga program weekly, and fill out inform consent.&#xD;
&#xD;
          -  Patients with breast cancer after complete treatment for at least 3 months (including&#xD;
             surgery and / or radiotherapy and/or chemotherapy).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  male&#xD;
&#xD;
          -  overweight&#xD;
&#xD;
          -  unable to do yoga exercise.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shu-Hui Yeh, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Chang Bing Show Chwan Memorial Hospital &amp; Central Taiwan University of Science and Technology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kuender D. Yang, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Chang Bing Show Chwan Memorial Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shin-Mae Wang, MD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Show Chwan Memorial Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shin-Mae Wang, MD.</last_name>
    <email>wangznmg@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Shu-Hui Yeh Yeh, PhD</last_name>
    <email>yehshuhui@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital</name>
      <address>
        <city>Changhua County</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kuender D. Yang, PhD</last_name>
      <phone>886-975617006</phone>
      <email>yangkd.yeh@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <last_update_submitted>September 16, 2014</last_update_submitted>
  <last_update_submitted_qc>September 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 17, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chang Bing Show Chwan Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Shu-Hui Yeh</investigator_full_name>
    <investigator_title>RN, PhD, Professor</investigator_title>
  </responsible_party>
  <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/NCT02243163
org study id: 1020106
nct id: NCT02243163
lead sponsor: 
has dmc: No
The purpose of study is to investigate if yoga exercise improve life quality and immune
      status in breast cancer patients after complete treatment (including surgery and / or
      radiotherapy and / or chemotherapy)
It is well-known that exercise promote immune regulation for better life quality. However,
      the mechanism for better immunity and life quality is not clear. We postulate that Ayurveda
      yoga might benefit breast cancer women with completion of operation and/or chemotherapy and
      radiotherapy. The benefits could be due to immune modulation, and improve health perception
      and life quality, and even potential decrease of cancer relapse.

      The study patients will do yoga twice a week for 12 weeks. The study primary endpoints are 1)
      to improve personal health perception, 2) to improve life quality and 3) to enhance human
      immunity. The study secondary endpoint will follow up the immunity changes 3 months after the
      intervention.

      We anticipate to reach the primary endpoints and to publish the primary results in one year,
      the secondary endpoint will complete in the second year.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: Single (Outcomes Assessor)
measure: Improve personal health and life quality
time frame: Change from baseline in personal health and life quality at 6 months.
description: Health and life quality will assessed by modified fatigue inventory and EORTC QLQ-C30 (version 3) at three different times: (1)baseline data: before yoga exercise, (2)outcome data: at 6 and 12 weeks post-test.
measure: Immune modulation
time frame: Change from baseline in human immunity at 3 months.
description: Lymphocytes will be extracted from peripheral blood for analyses of lymphocytes subpopulation (Th1/ Th2/ Treg/ Th17), polarization (T-bet/ Gata-3/ Foxp3/ RORrt) and its related cytokines (Th1: IL-12/ IFN-γ/ IL-27; Th2: IL-4/ IL-13/ IL-25; Th17: IL-17A/ IL-6/ IL-21; Treg: TGF/ IL-10. Saliva collection for analyses of cortisol and IL-6 at 3 different times: (1) baseline data: before yoga exercise, (2)outcome data: at 6 and 12 weeks post-test.
arm group label: Yoga exercise
arm group type: Experimental
description: Subjects will receive regular 90-minutes yoga classes twice a week for 3 months.
intervention type: Behavioral
intervention name: Yoga exercise
description: Subjects will receive regular 90-minutes yoga classes twice a week for 3 months.
arm group label: Yoga exercise
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Shu-Hui Yeh, PhD
role: Study Chair
affiliation: Chang Bing Show Chwan Memorial Hospital & Central Taiwan University of Science and Technology
last name: Kuender D. Yang, PhD
role: Study Director
affiliation: Chang Bing Show Chwan Memorial Hospital
last name: Shin-Mae Wang, MD.
role: Principal Investigator
affiliation: Show Chwan Memorial Hospital
last name: Shin-Mae Wang, MD.
email: wangznmg@gmail.com
last name: Shu-Hui Yeh Yeh, PhD
email: yehshuhui@gmail.com
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Chang Bing Show Chwan Memorial Hospital
investigator full name: Shu-Hui Yeh
investigator title: RN, PhD, Professor
mesh term: Breast Neoplasms