<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/NCT03244605</url>
  </required_header>
  <id_info>
    <org_study_id>SHUTCM001</org_study_id>
    <nct_id>NCT03244605</nct_id>
  </id_info>
  <brief_title>Efficacy Study of Comprehensive Rehabilitation Program in Postoperative NSCLC Patients</brief_title>
  <official_title>Clinical Study on the Effect of Comprehensive Rehabilitation Program on Quality of Life and Long-term Survival in Postoperative Non Small Cell Lung Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shanghai Chest Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Pulmonary Hospital, Shanghai, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Cancer Hospital, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Huadong Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shanghai 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>
      The investigators performed a multi-centered, randomized, placebo-controlled, prospective&#xD;
      clinical trial on the effect of comprehensive rehabilitation program to improve quality of&#xD;
      life(QOL) and long-term survival of postoperative patients with early lung cancer. The&#xD;
      investigators plan to enroll 236 cases in 3 years (118 cases for rehabilitation training plus&#xD;
      traditional Chinese medicine (TCM), 118 cases for rehabilitation education plus placebo),&#xD;
      expecting that comprehensive rehabilitation program has a better efficacy on improving QOL&#xD;
      and long-term survival.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Non-Small-Cell Lung Cancer（NSCLC）is one of the malignancies with high incidence and&#xD;
      mortality. In recent years, surgery become the preferred treatment for early stage of NSCLC.&#xD;
      Patients with stage IA-IIIA lung cancer can undergo radical surgery, but postoperative lung&#xD;
      cancer patients also have shortness of breath, chest pain, cough, expectoration, upper limb&#xD;
      dysfunction and other symptoms. The symptoms seriously affect the quality of life and&#xD;
      follow-up treatment. Comprehensive rehabilitation program may alleviate the symptoms as an&#xD;
      effective treatment which including rehabilitation training and TCM.&#xD;
&#xD;
      The investigators performed a multi-centered, randomized, placebo-controlled, prospective&#xD;
      clinical trial on the effect of comprehensive rehabilitation program to improve quality of&#xD;
      life(QOL) and long-term survival of postoperative patients who are not recommended for&#xD;
      postoperative chemotherapy at stage IA and IB. Patients are randomized into observational&#xD;
      group (rehabilitation training plus TCM), and control group (rehabilitation education plus&#xD;
      placebo). The treatment should be last three months and the patients will be followed up&#xD;
      regularly. The primary efficacy assessments are: (1) QOL (QLQ-LC43 scale); (2) Pulmonary&#xD;
      function test(PFTs): 1) Forced vital capacity (FVC); 2) Forced expiratory volume in one&#xD;
      second (FEV1); 3) Forced expiratory flow rate from 25% to 50% (FEF25-50); 4) Residual volume&#xD;
      (RV); 5) Total lung capacity (TLC). Secondary efficacy assessments are: (1) 2 years&#xD;
      disease-free survival; (2) TCM symptoms changes; (3) Tumer markers (CEA, CA-125 and&#xD;
      CYFRA21-1); (4) Exercise tolerance; (5) Toxicity, side effects and security of the treatments&#xD;
      will be assessed at the same time. The investigators plan to enroll 236 cases in 3 years (118&#xD;
      cases for rehabilitation training plus TCM, 118 cases for rehabilitation education plus&#xD;
      placebo), expecting that comprehensive rehabilitation program has a better efficacy on&#xD;
      improving QOL and long-term survival.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">October 1, 2016</start_date>
  <completion_date type="Anticipated">December 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2019</primary_completion_date>
  <phase>Phase 3</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in Quality of life (QOL)</measure>
    <time_frame>baseline, at 3 months</time_frame>
    <description>QOL is assessed using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 43 (EORTC QLQ-LC43).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Residual capacity (RV)</measure>
    <time_frame>after intervention at 2 weeks</time_frame>
    <description>RV is measured in a test known as Lung valume(LV)spirometry,a type of pulmonary function test.RV is the volume of air remaining in the lungs after a maximal expiratory effort.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total lung capacity（TLC）</measure>
    <time_frame>after intervention at 2 weeks</time_frame>
    <description>TLC is measured in a test known as Lung valume(LV)spirometry,a type of pulmonary function test.TLC equals the vital capacity plus the residual capacity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forced vital capacity (FVC)</measure>
    <time_frame>after intervention at 2 weeks</time_frame>
    <description>FVC is the volume of air exhaled with maximum effort and speed after a full inspiration. FVC is measured in a test known as spirometry, a type of pulmonary function test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forced expiratory volume in one second(FEV1)</measure>
    <time_frame>after intervention at 2 weeks</time_frame>
    <description>FEV1 is an individual test measure used to assess limitations in airflow, a type of pulmonary function test,which measures the amount of air exhaled in onesecond.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum mid expiratory flow(MMEF)</measure>
    <time_frame>after intervention at 2 weeks</time_frame>
    <description>MMEF is forced expiratory flow between 25% and 75% of forced vital capacity,a type of pulmonary function test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-free survival (DFS)</measure>
    <time_frame>From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months</time_frame>
    <description>Time from randomization to first recurrence or metastasis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TCM symptoms changes</measure>
    <time_frame>after intervention at 3 months</time_frame>
    <description>TCM symptoms changes are according to the lung cancer symptom classification quantization table in &quot;Guiding Principles for Clinical Research of Traditional Chinese Medicine in the Treatment of Lung Cancer (2002 Edition)&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumor markers</measure>
    <time_frame>after intervention at 3 months</time_frame>
    <description>Tumor markers include CEA, CA-125 and CYFRA21-1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety assessment evaluated according to Common Toxicity Criteria</measure>
    <time_frame>after intervention at 3 months</time_frame>
    <description>Safety assessment is evaluated according to Common Toxicity Criteria (CTC 3.0)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">236</enrollment>
  <condition>Non-small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Rehabilitation training plus TCM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rehabilitation training include aerobic exercise training and Liu Zi Jue lung exercises, which will be started in one month after operation.&#xD;
Prescriptions formulated into granules origin from Professor Xu Ling in Yueyang hospital. Package of granules is made into three types with functions such as benefiting Qi recipe, benefiting Yin recipe and detoxication and resolving masses recipe. Each package contained 20g of water-soluble herbal granules that were manufactured at a Good Manufacture Practice standard facility (Tian Jiang Ltd, Jiangyin, China). Each package was labeled with a serial number. The prescription form comprised the stock list with both the name and serial number.The patient will take TCM granules for 3 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rehabilitation education plus placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients who received rehabilitation education will not accept rehabilitation training.&#xD;
We compromise the raw materials for the placebo including food color and artificial flavors. The placebo and therapeutic packages were stored in different cabinets, and only the dispensing technician knew the contents of the packages.&#xD;
The patient will take placebo granules for 3 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Rehabilitation Training</intervention_name>
    <description>Patients will be trained in one month after operation. Rehabilitation training include aerobic exercise training (using cycle ergometer for 7-14 times at all, once a day, 15-20 min/time and using treadmill for 7-14 times at all, once a day, 15-20 min/time according to the patient's endurance) and Liu Zi Jue lung exercises, which strengthen the lung function of the human body in Chinese traditional health culture, five times a week, 15 min/time.</description>
    <arm_group_label>Rehabilitation training plus TCM</arm_group_label>
    <other_name>aerobic exercise training</other_name>
    <other_name>Liu Zi Jue lung exercises</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Rehabilitation Education</intervention_name>
    <description>General health education</description>
    <arm_group_label>Rehabilitation education plus placebo</arm_group_label>
    <other_name>health education</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TCM</intervention_name>
    <description>three types with functions such as benefiting Qi recipe, benefiting Yin recipe and detoxication and resolving masses recipe.</description>
    <arm_group_label>Rehabilitation training plus TCM</arm_group_label>
    <other_name>Prescriptions from Professor Xu Ling</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>three types with functions such as benefiting Qi recipe, benefiting Yin recipe and detoxication and resolving masses recipe，with the same color, smell，taste weight and package</description>
    <arm_group_label>Rehabilitation education plus placebo</arm_group_label>
    <other_name>control</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pathologically or cytologically confirmed stage Ia-IIIa non small cell lung cancer;&#xD;
&#xD;
          -  Between the ages of 18 to 75 years old;&#xD;
&#xD;
          -  The score of ECOG ≥2 points&#xD;
&#xD;
          -  Without major organ dysfunction: hemoglobin ≥10 g/dL, absolute neutrophil count (ANC)&#xD;
             ≥1.5*10^9/L, platelets ≥100 *10^9/L; normal hepatic and renal function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Indefinite pathological diagnosis;&#xD;
&#xD;
          -  Expected survival time &lt; 6 months&#xD;
&#xD;
          -  Combined with heart, liver, kidney and hematopoietic system and other serious diseases&#xD;
&#xD;
          -  The patient was treated with antibiotics or infected one week before the test;&#xD;
&#xD;
          -  Pregnant or child breast feeding women;&#xD;
&#xD;
          -  Mental or cognitive disorders;&#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_official>
    <last_name>Ling Xu, MD &amp; PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai University of Traditional Chinese Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>YueYang Hosptial of Intergrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200437</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>July 19, 2017</study_first_submitted>
  <study_first_submitted_qc>August 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>June 11, 2019</last_update_submitted>
  <last_update_submitted_qc>June 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2019</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>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03244605
org study id: SHUTCM001
nct id: NCT03244605
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigators performed a multi-centered, randomized, placebo-controlled, prospective
      clinical trial on the effect of comprehensive rehabilitation program to improve quality of
      life(QOL) and long-term survival of postoperative patients with early lung cancer. The
      investigators plan to enroll 236 cases in 3 years (118 cases for rehabilitation training plus
      traditional Chinese medicine (TCM), 118 cases for rehabilitation education plus placebo),
      expecting that comprehensive rehabilitation program has a better efficacy on improving QOL
      and long-term survival.
Non-Small-Cell Lung Cancer（NSCLC）is one of the malignancies with high incidence and
      mortality. In recent years, surgery become the preferred treatment for early stage of NSCLC.
      Patients with stage IA-IIIA lung cancer can undergo radical surgery, but postoperative lung
      cancer patients also have shortness of breath, chest pain, cough, expectoration, upper limb
      dysfunction and other symptoms. The symptoms seriously affect the quality of life and
      follow-up treatment. Comprehensive rehabilitation program may alleviate the symptoms as an
      effective treatment which including rehabilitation training and TCM.

      The investigators performed a multi-centered, randomized, placebo-controlled, prospective
      clinical trial on the effect of comprehensive rehabilitation program to improve quality of
      life(QOL) and long-term survival of postoperative patients who are not recommended for
      postoperative chemotherapy at stage IA and IB. Patients are randomized into observational
      group (rehabilitation training plus TCM), and control group (rehabilitation education plus
      placebo). The treatment should be last three months and the patients will be followed up
      regularly. The primary efficacy assessments are: (1) QOL (QLQ-LC43 scale); (2) Pulmonary
      function test(PFTs): 1) Forced vital capacity (FVC); 2) Forced expiratory volume in one
      second (FEV1); 3) Forced expiratory flow rate from 25% to 50% (FEF25-50); 4) Residual volume
      (RV); 5) Total lung capacity (TLC). Secondary efficacy assessments are: (1) 2 years
      disease-free survival; (2) TCM symptoms changes; (3) Tumer markers (CEA, CA-125 and
      CYFRA21-1); (4) Exercise tolerance; (5) Toxicity, side effects and security of the treatments
      will be assessed at the same time. The investigators plan to enroll 236 cases in 3 years (118
      cases for rehabilitation training plus TCM, 118 cases for rehabilitation education plus
      placebo), expecting that comprehensive rehabilitation program has a better efficacy on
      improving QOL and long-term survival.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change from baseline in Quality of life (QOL)
time frame: baseline, at 3 months
description: QOL is assessed using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 43 (EORTC QLQ-LC43).
measure: Residual capacity (RV)
time frame: after intervention at 2 weeks
description: RV is measured in a test known as Lung valume(LV)spirometry,a type of pulmonary function test.RV is the volume of air remaining in the lungs after a maximal expiratory effort.
measure: Total lung capacity（TLC）
time frame: after intervention at 2 weeks
description: TLC is measured in a test known as Lung valume(LV)spirometry,a type of pulmonary function test.TLC equals the vital capacity plus the residual capacity.
measure: Forced vital capacity (FVC)
time frame: after intervention at 2 weeks
description: FVC is the volume of air exhaled with maximum effort and speed after a full inspiration. FVC is measured in a test known as spirometry, a type of pulmonary function test.
measure: Forced expiratory volume in one second(FEV1)
time frame: after intervention at 2 weeks
description: FEV1 is an individual test measure used to assess limitations in airflow, a type of pulmonary function test,which measures the amount of air exhaled in onesecond.
measure: Maximum mid expiratory flow(MMEF)
time frame: after intervention at 2 weeks
description: MMEF is forced expiratory flow between 25% and 75% of forced vital capacity,a type of pulmonary function test.
measure: Disease-free survival (DFS)
time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
description: Time from randomization to first recurrence or metastasis
measure: TCM symptoms changes
time frame: after intervention at 3 months
description: TCM symptoms changes are according to the lung cancer symptom classification quantization table in "Guiding Principles for Clinical Research of Traditional Chinese Medicine in the Treatment of Lung Cancer (2002 Edition)"
measure: Tumor markers
time frame: after intervention at 3 months
description: Tumor markers include CEA, CA-125 and CYFRA21-1
measure: Safety assessment evaluated according to Common Toxicity Criteria
time frame: after intervention at 3 months
description: Safety assessment is evaluated according to Common Toxicity Criteria (CTC 3.0)
arm group label: Rehabilitation training plus TCM
arm group type: Experimental
description: Rehabilitation training include aerobic exercise training and Liu Zi Jue lung exercises, which will be started in one month after operation.
Prescriptions formulated into granules origin from Professor Xu Ling in Yueyang hospital. Package of granules is made into three types with functions such as benefiting Qi recipe, benefiting Yin recipe and detoxication and resolving masses recipe. Each package contained 20g of water-soluble herbal granules that were manufactured at a Good Manufacture Practice standard facility (Tian Jiang Ltd, Jiangyin, China). Each package was labeled with a serial number. The prescription form comprised the stock list with both the name and serial number.The patient will take TCM granules for 3 months.
arm group label: Rehabilitation education plus placebo
arm group type: Placebo Comparator
description: Patients who received rehabilitation education will not accept rehabilitation training.
We compromise the raw materials for the placebo including food color and artificial flavors. The placebo and therapeutic packages were stored in different cabinets, and only the dispensing technician knew the contents of the packages.
The patient will take placebo granules for 3 months.
intervention type: Other
intervention name: Rehabilitation Training
description: Patients will be trained in one month after operation. Rehabilitation training include aerobic exercise training (using cycle ergometer for 7-14 times at all, once a day, 15-20 min/time and using treadmill for 7-14 times at all, once a day, 15-20 min/time according to the patient's endurance) and Liu Zi Jue lung exercises, which strengthen the lung function of the human body in Chinese traditional health culture, five times a week, 15 min/time.
arm group label: Rehabilitation training plus TCM
other name: aerobic exercise training
other name: Liu Zi Jue lung exercises
intervention type: Other
intervention name: Rehabilitation Education
description: General health education
arm group label: Rehabilitation education plus placebo
other name: health education
intervention type: Drug
intervention name: TCM
description: three types with functions such as benefiting Qi recipe, benefiting Yin recipe and detoxication and resolving masses recipe.
arm group label: Rehabilitation training plus TCM
other name: Prescriptions from Professor Xu Ling
intervention type: Drug
intervention name: placebo
description: three types with functions such as benefiting Qi recipe, benefiting Yin recipe and detoxication and resolving masses recipe，with the same color, smell，taste weight and package
arm group label: Rehabilitation education plus placebo
other name: control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Ling Xu, MD & PhD
role: Principal Investigator
affiliation: Shanghai University of Traditional Chinese Medicine
facility: 
country: China
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
sharing ipd: No