<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/NCT03245554</url>
  </required_header>
  <id_info>
    <org_study_id>2017 PROP/CSU/GC</org_study_id>
    <nct_id>NCT03245554</nct_id>
  </id_info>
  <brief_title>Clinical Research on Teratment of Gastrointestinal Cancer in the Preoperative by Propranolol</brief_title>
  <official_title>Clinical Research on Teratment of Gastrointestinal Cancer in the Preoperative by Propranolol</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central South University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central South University</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>
      To research the effect of propranolol on the proliferation and apoptosis of gastrointestinal&#xD;
      cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">May 1, 2018</start_date>
  <completion_date type="Anticipated">September 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2020</primary_completion_date>
  <phase>Early Phase 1</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tumor size will be measured.</measure>
    <time_frame>Our experiment completed after patients took medicine for one week.</time_frame>
    <description>We used CT and Ki67 to confirm that the drug's affection.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Gastrointestinal Cancer</condition>
  <arm_group>
    <arm_group_label>placebo and propranolol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>We used propranolol and placebo as an control drug to treat with patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propranolol</intervention_name>
    <description>0 or 1 were generated by using Random software. The patient entered the placebo group if number was 0; if the random number generated was 1, then entered the propranolol group.</description>
    <arm_group_label>placebo and propranolol</arm_group_label>
    <other_name>placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. patients with gastric adenocarcinoma and colon cancer were diagnosed by histology and&#xD;
             cytology, and there was a clear metastasis (TxNxM0);&#xD;
&#xD;
          2. without any prior treatment (including surgery or radiotherapy and chemotherapy) in&#xD;
             the I-III period, no distant metastasis, suitable for patients with surgical resection&#xD;
             of the tumor.&#xD;
&#xD;
          3. the age range of the patients is 18-60;&#xD;
&#xD;
          4. systolic pressure 100-140mmHg; heart rate &gt;60bpm;&#xD;
&#xD;
          5. the patient's survival time should be longer than 3 months;&#xD;
&#xD;
          6. without previous cardiovascular and cerebrovascular diseases, the atrioventricular&#xD;
             block was excluded by the 24 hour dynamic electrocardiogram;&#xD;
&#xD;
          7. ECOG score of 2 (that means the patient's bed time is less than 50%); Karnofsky score&#xD;
             of 60% (that means patients have the basic activities and self-care ability);&#xD;
&#xD;
          8. the basic biochemical examination results of patients with normal: white blood cell&#xD;
             3000/ul; neutrophil 1500/ul 100000/ul; platelet count; total bilirubin &lt; 1.5 x ULN;&#xD;
             AST / ALT 2.5 x ULN without liver metastasis; &lt; 5 x ULN liver metastasis; creatinine&#xD;
             clearance rate of 1.5 x ULN;&#xD;
&#xD;
          9. have the ability to understand and sign informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. pregnant or lactating women;&#xD;
&#xD;
          2. patients with severe heart disease, kidney disease, metabolic disorders, bronchial&#xD;
             asthma, cardiogenic shock, heart block (II-III degree atrioventricular block), or&#xD;
             severe acute heart failure, sinus bradycardia.&#xD;
&#xD;
          3. patients with epilepsy or psychotropic drugs and sedatives;&#xD;
&#xD;
          4. patients with brain metastasis and bone marrow metastasis;&#xD;
&#xD;
          5. participants in clinical trials of other drugs within 4 weeks;&#xD;
&#xD;
          6. patients with a history of anaphylaxis with propranolol;&#xD;
&#xD;
          7. patients treated with trastuzumab;&#xD;
&#xD;
          8. patients with or reactive immunodeficiency, such as those with HIV infection;&#xD;
&#xD;
          9. the uncontrollable situation in the group during the period (but not limited to these&#xD;
             cases): according to the experimental scheme of medication, severe infection, due to&#xD;
             mental illness or other social factors lead to the compliance requirements of&#xD;
             patients;&#xD;
&#xD;
         10. patients with atrioventricular block should be discontinued immediately and quit;&#xD;
&#xD;
         11. the researchers believe there may be any increase in the risk of the subject or any&#xD;
             interference with clinical trials.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yijing He</last_name>
    <phone>+86-1587481262</phone>
    <email>yijinghe@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Institute of Clinical Pharmacology</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410005</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>April 6, 2018</last_update_submitted>
  <last_update_submitted_qc>April 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Central South University</investigator_affiliation>
    <investigator_full_name>Yijing He</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Gastrointestinal Cancer</keyword>
  <keyword>Propranolol</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastrointestinal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propranolol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03245554
org study id: 2017 PROP/CSU/GC
nct id: NCT03245554
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To research the effect of propranolol on the proliferation and apoptosis of gastrointestinal
      cancer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Tumor size will be measured.
time frame: Our experiment completed after patients took medicine for one week.
description: We used CT and Ki67 to confirm that the drug's affection.
arm group label: placebo and propranolol
arm group type: Experimental
description: We used propranolol and placebo as an control drug to treat with patients.
intervention type: Drug
intervention name: Propranolol
description: 0 or 1 were generated by using Random software. The patient entered the placebo group if number was 0; if the random number generated was 1, then entered the propranolol group.
arm group label: placebo and propranolol
other name: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Yijing He
phone: +86-1587481262
email: yijinghe@gmail.com
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Central South University
investigator full name: Yijing He
investigator title: Associate Professor
mesh term: Gastrointestinal Neoplasms
mesh term: Propranolol
sharing ipd: Undecided