<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/NCT04482829</url>
  </required_header>
  <id_info>
    <org_study_id>TCM for lung adenocarcinoma</org_study_id>
    <nct_id>NCT04482829</nct_id>
  </id_info>
  <brief_title>TCM in the Treatment of Lung Adenocarcinoma</brief_title>
  <official_title>Efficacy and Safety of Jing-yuan-kang Granule in the Treatment of Lung Adenocarcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Henan University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Henan University of Traditional Chinese Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to evaluate the efficacy and safety of Jin-yuan-kang granule in the treatment&#xD;
      of lung adenocarcinoma (LUAD) preliminarily, and provide reference for further study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lung adenocarcinoma (LUAD) is a type of non-small cell lung cancer (NSCLC) with a rapid&#xD;
      disease progression and poor treatment effect. The LUAD patients have a short median survival&#xD;
      time with 8-11 months. Up to now, chemotherapy is still the first-line treatment for LUAD. PC&#xD;
      protocol (pemetrexed + cisplatin) is most commonly used, which is also recommended by NCCN&#xD;
      guidelines. However, critical side effects have limited the application and efficacy.&#xD;
      Patients will undergo poor quality of life, and the disease will progress rapidly. We still&#xD;
      face the stern situation for the treatment of LUAD. It is urgent to develop new treatment and&#xD;
      management strategies. Our previous study showed that jing-yuan-kang granule has certain&#xD;
      curative effect on LUAD.&#xD;
&#xD;
      This is a multi-certers, randomized, controlled clinical trial to assess the efficacy and&#xD;
      safety of Jing-yuan-kang granule in improving quality of life for LUAD patients. After a&#xD;
      2-week wash-out period, a total of 144 LUAD patients will be randomly assigned into&#xD;
      experimental or control group with a ratio of 1:1. On the basis of that all the participants&#xD;
      will receive PC chemotherapy and symptomatic treatment, the patients in the experimental&#xD;
      group will receive jing-yuan-kang granule with no other treatments for control group. The&#xD;
      primary outcome is quality of life. The secondary outcomes include Karnofsky (KPS) scores,&#xD;
      clinical symptoms, and change of tumor volume. Safety and adverse events will also be&#xD;
      assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 15, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2020</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>The quality of life will be evaluated by The European Organization for Research and Treatment of Cancer Quality of life Questinnaire Core-30(EORTC QLQ-C30) scale</measure>
    <time_frame>Change at 3 weeks, 6 weeks, 9 weeks, and 12 weeks after treatment compared to baseline.</time_frame>
    <description>A score of 1-4 will be administrated for each item in EORTC QLQ-C30 . The higher scores will indicate the worse outcomes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life will be evaluated by Quality of life Questinnaire Lung Cancer-13(QLQ-LC13)</measure>
    <time_frame>Change at 3 weeks, 6 weeks, 9 weeks, and 12 weeks after treatment compared to baseline.</time_frame>
    <description>A score of 1-4 will be administrated for each item in QLQ-LC13. The higher scores will indicate the worse outcomes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Karnofsky(KPS) scores</measure>
    <time_frame>Change at 3 weeks, 6 weeks, 9 weeks, and 12 weeks after treatment compared to baseline.</time_frame>
    <description>Physical conditions will be evaluated by KPS scores with a score of 0-100. A higher score will indicate a better physical conditon.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TCM syndrome index</measure>
    <time_frame>Change at 3 weeks, 6 weeks, 9 weeks, and 12 weeks after treatment compared to baseline.</time_frame>
    <description>TCM symptom index will be recorded and calculated referring to the Guiding Principles of Clinical Research of New Chinese Medicine Treating Primary Bronchial Lung Cancer (2002 Edition) published by National Medical Products Administration of China. A total of scores of all the related symptoms will be calculated with a 0-4 for each symptom at baseline and after treatment. A higher value will indicate a worse symptom. The difference of TCM symptoms between baseline and posttreatment will be calculated first. Then, we will obtain the TCM syndrome index by the ratio between the above difference and the scores at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of tumor volume</measure>
    <time_frame>Change at 12 weeks after treatment compared to baseline.</time_frame>
    <description>Change of tumor volume will be assessed by the length of longest diameter. The longger diameter will indicate worse disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events will be evaluated and recorded at any time.</measure>
    <time_frame>at baseline, up to 6 weeks and 12 weeks after treatment.</time_frame>
    <description>Safety</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">144</enrollment>
  <condition>Lung Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Experimental Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>On the basis of PC chemotherapy and symptomatic treatment, the patients in the experimental group will receive jing-yuan-kang granule with one dose daily.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All the patients in control group will receive PC chemotherapy and symptomatic treatment without other treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Jing-yan-kang Granule</intervention_name>
    <description>Jing-yuan-kang granule will be administered 6 days on and 1 days off for 12weeks.</description>
    <arm_group_label>Experimental Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PC chemotherapy and symptomatic treatment</intervention_name>
    <description>Drugs used in PC chemotherapy includes Pemetrexed and Cisplatin. Pemetrexed disodium for injection 500 mg per square meter, intravenous drip on day 1 in each treatment cycle.&#xD;
Cisplatin injection 75 mg per square meter, intravenous drip from day 1 to day 3 in each treatment cycle. One treatment cycle will be continued for 21 days and 4 cycles will be performed.&#xD;
If necessary, symptomatic treatment will also be used.</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Experimental Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A confirmed diagnosis of LADC.&#xD;
&#xD;
          -  Age ranges from17years to75years.&#xD;
&#xD;
          -  A KPS score ≥40.&#xD;
&#xD;
          -  Without radiotherapy, immunotherapy and targeted therapy.&#xD;
&#xD;
          -  Without participanting in any other trial.&#xD;
&#xD;
          -  With signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant, nursing or may become pregnant women.&#xD;
&#xD;
          -  The patient has a history of allergy to any of the components of the intervention&#xD;
             drug;&#xD;
&#xD;
          -  Patients with severe liver and kidney dysfunction, cardiovascular and cerebrovascular&#xD;
             diseases.&#xD;
&#xD;
          -  Unconscious or unable to communicate normally.&#xD;
&#xD;
          -  Patients with poor compliance.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Dan-dan Wei</last_name>
    <phone>+8613849186250</phone>
    <email>1617924593@qq.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Shi-qing Jiang</last_name>
    <phone>+8613607640006</phone>
    <email>jiangshiqing66@126.com</email>
  </overall_contact_backup>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 18, 2020</last_update_submitted>
  <last_update_submitted_qc>July 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Adenocarcinoma of Lung</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/NCT04482829
org study id: TCM for lung adenocarcinoma
nct id: NCT04482829
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is to evaluate the efficacy and safety of Jin-yuan-kang granule in the treatment
      of lung adenocarcinoma (LUAD) preliminarily, and provide reference for further study.
Lung adenocarcinoma (LUAD) is a type of non-small cell lung cancer (NSCLC) with a rapid
      disease progression and poor treatment effect. The LUAD patients have a short median survival
      time with 8-11 months. Up to now, chemotherapy is still the first-line treatment for LUAD. PC
      protocol (pemetrexed + cisplatin) is most commonly used, which is also recommended by NCCN
      guidelines. However, critical side effects have limited the application and efficacy.
      Patients will undergo poor quality of life, and the disease will progress rapidly. We still
      face the stern situation for the treatment of LUAD. It is urgent to develop new treatment and
      management strategies. Our previous study showed that jing-yuan-kang granule has certain
      curative effect on LUAD.

      This is a multi-certers, randomized, controlled clinical trial to assess the efficacy and
      safety of Jing-yuan-kang granule in improving quality of life for LUAD patients. After a
      2-week wash-out period, a total of 144 LUAD patients will be randomly assigned into
      experimental or control group with a ratio of 1:1. On the basis of that all the participants
      will receive PC chemotherapy and symptomatic treatment, the patients in the experimental
      group will receive jing-yuan-kang granule with no other treatments for control group. The
      primary outcome is quality of life. The secondary outcomes include Karnofsky (KPS) scores,
      clinical symptoms, and change of tumor volume. Safety and adverse events will also be
      assessed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The quality of life will be evaluated by The European Organization for Research and Treatment of Cancer Quality of life Questinnaire Core-30(EORTC QLQ-C30) scale
time frame: Change at 3 weeks, 6 weeks, 9 weeks, and 12 weeks after treatment compared to baseline.
description: A score of 1-4 will be administrated for each item in EORTC QLQ-C30 . The higher scores will indicate the worse outcomes.
measure: Quality of life will be evaluated by Quality of life Questinnaire Lung Cancer-13(QLQ-LC13)
time frame: Change at 3 weeks, 6 weeks, 9 weeks, and 12 weeks after treatment compared to baseline.
description: A score of 1-4 will be administrated for each item in QLQ-LC13. The higher scores will indicate the worse outcomes.
measure: Karnofsky(KPS) scores
time frame: Change at 3 weeks, 6 weeks, 9 weeks, and 12 weeks after treatment compared to baseline.
description: Physical conditions will be evaluated by KPS scores with a score of 0-100. A higher score will indicate a better physical conditon.
measure: TCM syndrome index
time frame: Change at 3 weeks, 6 weeks, 9 weeks, and 12 weeks after treatment compared to baseline.
description: TCM symptom index will be recorded and calculated referring to the Guiding Principles of Clinical Research of New Chinese Medicine Treating Primary Bronchial Lung Cancer (2002 Edition) published by National Medical Products Administration of China. A total of scores of all the related symptoms will be calculated with a 0-4 for each symptom at baseline and after treatment. A higher value will indicate a worse symptom. The difference of TCM symptoms between baseline and posttreatment will be calculated first. Then, we will obtain the TCM syndrome index by the ratio between the above difference and the scores at baseline.
measure: Change of tumor volume
time frame: Change at 12 weeks after treatment compared to baseline.
description: Change of tumor volume will be assessed by the length of longest diameter. The longger diameter will indicate worse disease.
measure: Adverse events will be evaluated and recorded at any time.
time frame: at baseline, up to 6 weeks and 12 weeks after treatment.
description: Safety
arm group label: Experimental Group
arm group type: Experimental
description: On the basis of PC chemotherapy and symptomatic treatment, the patients in the experimental group will receive jing-yuan-kang granule with one dose daily.
arm group label: Control Group
arm group type: Other
description: All the patients in control group will receive PC chemotherapy and symptomatic treatment without other treatment.
intervention type: Drug
intervention name: Jing-yan-kang Granule
description: Jing-yuan-kang granule will be administered 6 days on and 1 days off for 12weeks.
arm group label: Experimental Group
intervention type: Drug
intervention name: PC chemotherapy and symptomatic treatment
description: Drugs used in PC chemotherapy includes Pemetrexed and Cisplatin. Pemetrexed disodium for injection 500 mg per square meter, intravenous drip on day 1 in each treatment cycle.
Cisplatin injection 75 mg per square meter, intravenous drip from day 1 to day 3 in each treatment cycle. One treatment cycle will be continued for 21 days and 4 cycles will be performed.
If necessary, symptomatic treatment will also be used.
arm group label: Control Group
arm group label: Experimental Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Dan-dan Wei
phone: +8613849186250
email: 1617924593@qq.com
last name: Shi-qing Jiang
phone: +8613607640006
email: jiangshiqing66@126.com
responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Adenocarcinoma of Lung