<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/NCT02261571</url>
  </required_header>
  <id_info>
    <org_study_id>CIMI-14-01-08</org_study_id>
    <nct_id>NCT02261571</nct_id>
  </id_info>
  <brief_title>Impact on Quality of Life by Moxibustion in Chemotherapy for Cancer</brief_title>
  <official_title>A Pilot Study to Estimate the Efficacy of Moxibustion Stimulation at Abdominal Acupoints on Quality of Life in Cancer Patients Under Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Comprehensive and Integrative Medicine Institute of South Korea</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Comprehensive and Integrative Medicine Institute of South Korea</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Most cancer patients experience multiple symptoms related to chemotherapy and use CAM&#xD;
      (complementary and alternative medicine) as an adjunct to conventional treatment. Moxibustion&#xD;
      is traditional Korean medical therapeutic method and uses the heat generated by burning&#xD;
      herbal preparations containing Artemisia vulgaris to stimulated acupoint.&#xD;
&#xD;
      Herein, the investigators propose an open-label pilot study investigating the effectiveness&#xD;
      of moxibustion stimulation at abdominal acupoint on quality of life in cancer patients under&#xD;
      chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">September 2015</completion_date>
  <primary_completion_date type="Anticipated">September 2015</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>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>functional Assessment of Cancer Therapy: General (FACT-G)</measure>
    <time_frame>change from baseline to 6 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body mass index</measure>
    <time_frame>change from baseline to 6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>immune function</measure>
    <time_frame>change from baseline to 6 weeks</time_frame>
    <description>lymphocyte panel(CD3,4,8,19,26), WBC, Differential count</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>M.D, Anderson symptom Inventory (MDASI)</measure>
    <time_frame>change from baseline to 6 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Moxibustion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A series of moxibustion sessions within six weeks from baseline with adjuvant chemotherapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waiting</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants who will be allocated to waitlist will receive no moxibustion treatments throughout the 6 weeks while receiving adjuvant chemotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Moxibustion</intervention_name>
    <description>In the moxibustion treatment group, 3 moxibustion, 3 acupoints(CV12, CV8, CV54) will be heated with indirected moxibustion.&#xD;
The moxibustion will be removed when the patient feel hotness and require remove them</description>
    <arm_group_label>Moxibustion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnostic histopathology of cancer&#xD;
&#xD;
          -  Performance status of 0-2 on the European Cooperative Oncology Group (ECOG)&#xD;
             performance scale.&#xD;
&#xD;
          -  Patients on chemotherapy currently have plan to receive chemotherapy for more than 6&#xD;
             weeks.&#xD;
&#xD;
          -  Follow-up possible during the clinical trial&#xD;
&#xD;
          -  Informed signed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with Severe Heart disease and hypertension that is not controlled (systolic&#xD;
             blood pressure &gt;160 or Diastolic blood pressure &gt;100)&#xD;
&#xD;
          -  Patients with diabetes that is not controlled (FBST &gt;180 or BST&gt;250)&#xD;
&#xD;
          -  Patients with abdominal injury or severe ascites can't be received moxibustion therapy&#xD;
             on abdomen.&#xD;
&#xD;
          -  Hypersensitive section to moxibustion treatment&#xD;
&#xD;
          -  Inability to comprehend or express oneself in the Korean language&#xD;
&#xD;
          -  An Individual deemed to be ineligible by a physician&#xD;
&#xD;
          -  Refusal to participate in this trial or to provide informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Hyun Jung Jung, KMD, Ph. D</last_name>
    <phone>+82537702082</phone>
    <email>koreancarmen@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Deagu Hanny University Medical center</name>
      <address>
        <city>Deagu</city>
        <zip>704-123</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <contact>
      <last_name>Hyun Jung Jung, KMD, Ph. D</last_name>
    </contact>
    <investigator>
      <last_name>Kyung Soon Kim, KMD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Lee MS, Kang JW, Ernst E. Does moxibustion work? An overview of systematic reviews. BMC Res Notes. 2010 Nov 5;3:284. doi: 10.1186/1756-0500-3-284.</citation>
    <PMID>21054851</PMID>
  </reference>
  <reference>
    <citation>Lee MS, Choi TY, Park JE, Lee SS, Ernst E. Moxibustion for cancer care: a systematic review and meta-analysis. BMC Cancer. 2010 Apr 7;10:130. doi: 10.1186/1471-2407-10-130.</citation>
    <PMID>20374659</PMID>
  </reference>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>October 9, 2014</last_update_submitted>
  <last_update_submitted_qc>October 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Comprehensive and Integrative Medicine Institute of South Korea</investigator_affiliation>
    <investigator_full_name>Hyun jung, Jung</investigator_full_name>
    <investigator_title>assistant professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT02261571
org study id: CIMI-14-01-08
nct id: NCT02261571
lead sponsor: 
has dmc: No
Most cancer patients experience multiple symptoms related to chemotherapy and use CAM
      (complementary and alternative medicine) as an adjunct to conventional treatment. Moxibustion
      is traditional Korean medical therapeutic method and uses the heat generated by burning
      herbal preparations containing Artemisia vulgaris to stimulated acupoint.

      Herein, the investigators propose an open-label pilot study investigating the effectiveness
      of moxibustion stimulation at abdominal acupoint on quality of life in cancer patients under
      chemotherapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: functional Assessment of Cancer Therapy: General (FACT-G)
time frame: change from baseline to 6 weeks
measure: Body mass index
time frame: change from baseline to 6 weeks
measure: immune function
time frame: change from baseline to 6 weeks
description: lymphocyte panel(CD3,4,8,19,26), WBC, Differential count
measure: M.D, Anderson symptom Inventory (MDASI)
time frame: change from baseline to 6 weeks
arm group label: Moxibustion
arm group type: Experimental
description: A series of moxibustion sessions within six weeks from baseline with adjuvant chemotherapy.
arm group label: Waiting
arm group type: No Intervention
description: Participants who will be allocated to waitlist will receive no moxibustion treatments throughout the 6 weeks while receiving adjuvant chemotherapy
intervention type: Other
intervention name: Moxibustion
description: In the moxibustion treatment group, 3 moxibustion, 3 acupoints(CV12, CV8, CV54) will be heated with indirected moxibustion.
The moxibustion will be removed when the patient feel hotness and require remove them
arm group label: Moxibustion
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
last name: Hyun Jung Jung, KMD, Ph. D
phone: +82537702082
email: koreancarmen@gmail.com
facility: 
contact: 
investigator: 
country: Korea, Republic of
citation: Lee MS, Kang JW, Ernst E. Does moxibustion work? An overview of systematic reviews. BMC Res Notes. 2010 Nov 5;3:284. doi: 10.1186/1756-0500-3-284.
PMID: 21054851
citation: Lee MS, Choi TY, Park JE, Lee SS, Ernst E. Moxibustion for cancer care: a systematic review and meta-analysis. BMC Cancer. 2010 Apr 7;10:130. doi: 10.1186/1471-2407-10-130.
PMID: 20374659
responsible party type: Principal Investigator
investigator affiliation: The Comprehensive and Integrative Medicine Institute of South Korea
investigator full name: Hyun jung, Jung
investigator title: assistant professor