<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/NCT04493489</url>
  </required_header>
  <id_info>
    <org_study_id>2020/prop/bladder/CSU</org_study_id>
    <nct_id>NCT04493489</nct_id>
  </id_info>
  <brief_title>Propranolol Adjuvant Treatment of Bladder Cancer</brief_title>
  <official_title>Propranolol Adjuvant Treatment of Bladder Cancer: a Randomized Phase II Clinical Trial</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Bladder cancer (bladder cancer) is the tenth most common cancer in the world, ranking 13th in&#xD;
      the number of deaths. There are about 549000 new cases of bladder cancer worldwide, with&#xD;
      200000 deaths and a higher incidence rate in men than in women. In 2013, the incidence rate&#xD;
      of bladder cancer was high in China, accounting for 2.02% of all new cases. Bladder cancer&#xD;
      has become a major disease threatening people's life and health. Therefore, the exploration&#xD;
      of the mechanism of the occurrence and development of bladder cancer and effective drugs has&#xD;
      been an important focus of bladder cancer research. The current treatment of bladder cancer&#xD;
      is mainly TURBT (transurethral resection of bladder tumour) resection and BCG, chemotherapy&#xD;
      adjuvant treatment, but its recurrence and metastasis still exist, so this study aims to&#xD;
      explore an effective drug treatment. The purpose of this study was to investigate the safety&#xD;
      and efficacy of propranolol in adjuvant BCG therapy, and whether propranolol can effectively&#xD;
      alleviate the metastasis and recurrence of bladder cancer and improve the survival time after&#xD;
      bladder cancer surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">September 6, 2020</start_date>
  <completion_date type="Anticipated">September 6, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 6, 2023</primary_completion_date>
  <phase>Phase 2</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>two-year recurrence-free survival</measure>
    <time_frame>24 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">242</enrollment>
  <condition>Bladder Cancer</condition>
  <arm_group>
    <arm_group_label>BCG</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>After TURBT, the first year: once a week for 6 times, from the 7th week, once every 2 weeks, and 3 times. Administer once a month starting from the 13th week and continue to give 10 times. Second and third years: once a month, 12 times a year.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Propranolol plus BCG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After TURBT administered for 2 consecutive years, oral propranolol, starting dose 10mg, tid, then 20mg, tid,lastly increased to 40mg, bid. After the last BCG infusion, propranolol was gradually reduced, in the order of 20 mg, tid to 10 mg, tid.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propranolol Hydrochloride</intervention_name>
    <description>Trial group: BCG + propranolol: after TURBT administered for 2 consecutive years, oral propranolol, starting dose 10mg, tid, then 20mg, tid,lastly increased to 40mg, bid. After the last BCG infusion, propranolol was gradually reduced, in the order of 20 mg, tid to 10 mg, tid.</description>
    <arm_group_label>Propranolol plus BCG</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BCG</intervention_name>
    <description>Control group: BCG vaccine: After TURBT, the first year: once a week for 6 times, from the 7th week, once every 2 weeks, and 3 times. Administer once a month starting from the 13th week and continue to give 10 times. Second and third years: once a month, 12 times a year.</description>
    <arm_group_label>BCG</arm_group_label>
    <arm_group_label>Propranolol plus BCG</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Ages 18 to 75&#xD;
&#xD;
          2. Patients with pathologically confirmed non-muscle invasive bladder cancer (T1 / Ta&#xD;
             high grade / CIS), according to the 2004 WHO classification criteria&#xD;
&#xD;
          3. No evidence of patients with muscular invasive disease&#xD;
&#xD;
          4. American Oncology Group ECOG score &lt;2&#xD;
&#xD;
          5. Patients' expected survival time should be more than 3 months&#xD;
&#xD;
          6. Organ function and hematopoietic function must meet the following requirements:&#xD;
             hemoglobin (HGB) ≥ 90g / L; white blood cell count (WBC) ≥ 3 × 10 ^ 9 / L; absolute&#xD;
             neutrophil count (ANC) ≥ 1.5 × 10 ^ 9 / L Platelet count (PLT) ≥100 × 10 ^ 9 / L;&#xD;
             total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN); aspartate aminotransferase&#xD;
             (AST) and alanine aminotransferase ( ALT) ≤ 2.5 × ULN; if abnormal liver function is&#xD;
             due to tumor liver metastasis, AST or ALT ≤ 5 × ULN; serum creatinine (Cr) ≤ 1.5 ×&#xD;
             ULN; international standardized ratio (INR) or plasma prothrombin time PT) ≤1.5 × ULN&#xD;
&#xD;
          7. Blood pressure with acceptable surgery: blood pressure greater than 90 / 60mmHg,&#xD;
             resting heart rate greater than 60 beats / min&#xD;
&#xD;
          8. Volunteer to participate in clinical research; fully understand, inform, and sign the&#xD;
             consent form; willing to follow and have the ability to complete all test procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Contraindications for propranolol: bronchial asthma, cardiogenic shock, cardiac block&#xD;
             (II-III degree Atrioventricular conduction block), severe or acute heart failure,&#xD;
             sinus bradycardia&#xD;
&#xD;
          2. In use or have used any beta-blockers for disease reasons in the past two years&#xD;
&#xD;
          3. Patients with other malignancies within 5 years before enrollment, in addition to&#xD;
             cervical carcinoma in situ and cured skin basal cell carcinoma with appropriate&#xD;
             treatment&#xD;
&#xD;
          4. Immunodeficiency, such as patients with HIV infection or other acquired, congenital&#xD;
             immunodeficiency diseases, or a history of organ transplantation&#xD;
&#xD;
          5. Patients with tumor brain metastases and bone marrow metastases were excluded, and&#xD;
             patients with liver metastases and lung metastases could be included&#xD;
&#xD;
          6. Participants who have participated in clinical studies of drugs other than BCG within&#xD;
             4 weeks&#xD;
&#xD;
          7. Patients with a history of allergy to propranolol&#xD;
&#xD;
          8. Alcohol, drug or substance abuse history in the past year&#xD;
&#xD;
          9. Subject has an active infection or an unexplained fever during screening, before the&#xD;
             first dose&gt; 38.5 degrees(According to the researcher's judgment, the subjects can be&#xD;
             enrolled due to the fever caused by the tumor)&#xD;
&#xD;
         10. Any situation that the investigator believes may increase the risk of the subject or&#xD;
             interfere with clinical trials&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 29, 2020</last_update_submitted>
  <last_update_submitted_qc>July 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder 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>
  <!-- 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/NCT04493489
org study id: 2020/prop/bladder/CSU
nct id: NCT04493489
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
Bladder cancer (bladder cancer) is the tenth most common cancer in the world, ranking 13th in
      the number of deaths. There are about 549000 new cases of bladder cancer worldwide, with
      200000 deaths and a higher incidence rate in men than in women. In 2013, the incidence rate
      of bladder cancer was high in China, accounting for 2.02% of all new cases. Bladder cancer
      has become a major disease threatening people's life and health. Therefore, the exploration
      of the mechanism of the occurrence and development of bladder cancer and effective drugs has
      been an important focus of bladder cancer research. The current treatment of bladder cancer
      is mainly TURBT (transurethral resection of bladder tumour) resection and BCG, chemotherapy
      adjuvant treatment, but its recurrence and metastasis still exist, so this study aims to
      explore an effective drug treatment. The purpose of this study was to investigate the safety
      and efficacy of propranolol in adjuvant BCG therapy, and whether propranolol can effectively
      alleviate the metastasis and recurrence of bladder cancer and improve the survival time after
      bladder cancer surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: two-year recurrence-free survival
time frame: 24 months
arm group label: BCG
arm group type: Placebo Comparator
description: After TURBT, the first year: once a week for 6 times, from the 7th week, once every 2 weeks, and 3 times. Administer once a month starting from the 13th week and continue to give 10 times. Second and third years: once a month, 12 times a year.
arm group label: Propranolol plus BCG
arm group type: Experimental
description: After TURBT administered for 2 consecutive years, oral propranolol, starting dose 10mg, tid, then 20mg, tid,lastly increased to 40mg, bid. After the last BCG infusion, propranolol was gradually reduced, in the order of 20 mg, tid to 10 mg, tid.
intervention type: Drug
intervention name: Propranolol Hydrochloride
description: Trial group: BCG + propranolol: after TURBT administered for 2 consecutive years, oral propranolol, starting dose 10mg, tid, then 20mg, tid,lastly increased to 40mg, bid. After the last BCG infusion, propranolol was gradually reduced, in the order of 20 mg, tid to 10 mg, tid.
arm group label: Propranolol plus BCG
intervention type: Drug
intervention name: BCG
description: Control group: BCG vaccine: After TURBT, the first year: once a week for 6 times, from the 7th week, once every 2 weeks, and 3 times. Administer once a month starting from the 13th week and continue to give 10 times. Second and third years: once a month, 12 times a year.
arm group label: BCG
arm group label: Propranolol plus BCG
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Central South University
investigator full name: Yijing He
investigator title: Associate Professor
mesh term: Urinary Bladder Neoplasms
mesh term: Propranolol