<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/NCT04496219</url>
  </required_header>
  <id_info>
    <org_study_id>RG1007421</org_study_id>
    <secondary_id>P30CA015704</secondary_id>
    <secondary_id>NCI-2020-05021</secondary_id>
    <secondary_id>10544</secondary_id>
    <nct_id>NCT04496219</nct_id>
  </id_info>
  <brief_title>Acupuncture for the Treatment of Intravesical BCG-Related Adverse Events in High-Risk Non-muscle Invasive Bladder Cancer</brief_title>
  <official_title>Acupuncture vs. Standard of Care for Induction Intravesical BCG-Related Adverse Events in High-Risk Non-Muscle Invasive Bladder Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fred Hutchinson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Fred Hutchinson Cancer Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase II trial studies the safety and feasibility of utilizing acupuncture in patients&#xD;
      with high-risk bladder cancer that has not spread to the surrounding muscle (non-muscle&#xD;
      invasive) undergoing treatment with Intravesical BCG. BCG is a weakened form of the bacterium&#xD;
      Mycobacterium bovis that does not cause disease. It is used in a solution to stimulate the&#xD;
      immune system in the treatment of bladder cancer. Unfortunately, many patients experience&#xD;
      side effects such as pelvic pain, painful urination, severe urgency, frequency, urge&#xD;
      incontinence, need to urinate at night, and/or infectious complications. These side effects&#xD;
      may cause patients to delay or stop BCG treatment. Acupuncture is a medical intervention in&#xD;
      which fine metallic needles are inserted into anatomical locations of the body to stimulate&#xD;
      the peripheral and the central nervous system. Giving acupuncture before each intravesical&#xD;
      BCG treatment may help to reduce the side effects of intravesical BCG, and help patients&#xD;
      complete treatment. Specific outcomes of interest include acceptability to patients, effect&#xD;
      of acupuncture on intravesical BCG-related side effects, and adverse events associated with&#xD;
      acupuncture.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OUTLINE: Patients are randomized to 1 of 2 arms.&#xD;
&#xD;
      ARM I: Patients undergo acupuncture therapy and receive BCG via intravesical injection on&#xD;
      days 1, 8, 15, 22, 29, and 36 in the absence of unacceptable toxicity. Patients also receive&#xD;
      standard of care symptom management.&#xD;
&#xD;
      ARM II: Patients receive BCG via intravesical injection on days 1, 8, 15, 22, 29, and 36 in&#xD;
      the absence of unacceptable toxicity. Patients also receive standard of care symptom&#xD;
      management. Patients may undergo acupuncture therapy after completion of intravesical BCG&#xD;
      therapy.&#xD;
&#xD;
      After completion of study, patients are followed up at 1 week.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 22, 2021</start_date>
  <completion_date type="Actual">August 23, 2022</completion_date>
  <primary_completion_date type="Actual">August 16, 2022</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Trial recruitment (proportion enrolled versus eligible, reason for not enrolling)</measure>
    <time_frame>Up to 1 week after completion of treatment</time_frame>
    <description>Will be described via qualitative report.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trial retention (proportion retained versus all enrolled, reason for not completing)</measure>
    <time_frame>Baseline, up to 1 week after completion of treatment</time_frame>
    <description>Will be described via qualitative report. Successful retention is defined as continued participation within the trial until 1 week following completion of induction.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Protocol adherence (proportion adhered versus all enrolled, specifics for how protocol was not followed and why)</measure>
    <time_frame>Up to 1 week after completion of treatment</time_frame>
    <description>Will be described via qualitative report. Protocol adherence is defined as completion of the acupuncture interventions and follow-up surveys if randomized to the acupuncture arm or completion of the follow-up surveys if randomized to the control arm.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>At 3 weeks and after completion of treatment</time_frame>
    <description>Patients' responses to the Cancer Care Satisfaction survey at 3 weeks and at the conclusion of induction Bacillus Calmette-Guerin (BCG) between two arms will be compared using t-test.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinic staff's responses to surveys</measure>
    <time_frame>Up to 1 week after completion of treatment</time_frame>
    <description>Clinic staff's responses to surveys assessing the healthcare burden of this protocol and time spent undergoing the acupuncture therapy for the experimental arm will be described via qualitative report</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>Up to 1 week after completion of treatment</time_frame>
    <description>Adverse events associated with acupuncture therapy in the experimental arm will be described via qualitative report.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BCG instillation adherence (out of a possible planned six treatments)</measure>
    <time_frame>Up to 1 week after completion of treatment</time_frame>
    <description>BCG instillation adherence (out of a possible planned six treatments (successful adherence defined as the number of successfully administered BCG instillations (of a possible 6 total), treatment interruptions (defined as number of weeks that a BCG instillation was delayed), weeks missed (measured as any vs none, and total weeks that BCG was not administered of the planned 6 weekly induction doses of intravesical BCG), intravesical BCG dwell times (measured in minutes), and requirement for dose reductions (measured as yes/no) between the acupuncture and control arms will be compared via t-test and chi-square as appropriate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bladder and bowel symptoms as self reported by patients</measure>
    <time_frame>From week 1 to week 6 of treatment</time_frame>
    <description>Compare the responses of patients in the experimental and control arms to the European Organization for Research and Treatment of Cancer - Non-Muscle Invasive Bladder Cancer 24 (EORTC-NMIBC24) symptom index, which was specifically designed to assess bladder and bowel symptoms for patients with NMIBC including assessments of impact of intravesical therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life: EORTC-QLQ-C30</measure>
    <time_frame>From week 1 to week 6 of treatment</time_frame>
    <description>Assessed using the EORTC Health and Quality of Life Rating Scale (EORTC-QLQ-C30).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median weekly pill counts of medications prescribed for the management of BCG-related side effects, standardized by dosage across medication types</measure>
    <time_frame>Up to 1 week after completion of treatment</time_frame>
    <description>Will be compared via Wilcoxon rank sum test.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Bladder Urothelial Carcinoma In Situ</condition>
  <condition>Recurrent Bladder Urothelial Carcinoma</condition>
  <condition>Stage 0a Bladder Cancer AJCC v8</condition>
  <condition>Stage 0is Bladder Cancer AJCC v8</condition>
  <condition>Stage I Bladder Cancer AJCC v8</condition>
  <condition>Superficial Bladder Urothelial Carcinoma</condition>
  <arm_group>
    <arm_group_label>Arm I (acupuncture, BCG)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo acupuncture therapy and receive BCG via intravesical injection on days 1, 8, 15, 22, 29, and 36 in the absence of unacceptable toxicity. Patients also receive standard of care symptom management.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II (BCG, standard of care)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receive BCG via intravesical injection on days 1, 8, 15, 22, 29, and 36 in the absence of unacceptable toxicity. Patients also receive standard of care symptom management. Patients may undergo acupuncture therapy after completion of intravesical BCG therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Acupuncture Therapy</intervention_name>
    <description>Undergo acupuncture therapy</description>
    <arm_group_label>Arm I (acupuncture, BCG)</arm_group_label>
    <arm_group_label>Arm II (BCG, standard of care)</arm_group_label>
    <other_name>Acupuncture</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>BCG Solution</intervention_name>
    <description>Given by intravesical injection</description>
    <arm_group_label>Arm I (acupuncture, BCG)</arm_group_label>
    <arm_group_label>Arm II (BCG, standard of care)</arm_group_label>
    <other_name>Bacillus Calmette Guerin Solution</other_name>
    <other_name>Bacillus Calmette-Guerin Solution</other_name>
    <other_name>TICE BCG Solution</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Best Practice</intervention_name>
    <description>Receive standard of care symptom management</description>
    <arm_group_label>Arm I (acupuncture, BCG)</arm_group_label>
    <arm_group_label>Arm II (BCG, standard of care)</arm_group_label>
    <other_name>standard of care</other_name>
    <other_name>standard therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm I (acupuncture, BCG)</arm_group_label>
    <arm_group_label>Arm II (BCG, standard of care)</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm I (acupuncture, BCG)</arm_group_label>
    <arm_group_label>Arm II (BCG, standard of care)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
          -  Diagnosis of American Urological Association (AUA) high-risk non-muscle invasive&#xD;
             bladder cancer (NMIBC), including high grade (HG) pT1 (invading only the lamina&#xD;
             propria of the bladder), recurrent HG pTa (superficial tumors), HG pTa &gt; 3 cm in size&#xD;
             or multifocal, any carcinoma in situ, any variant histology, any lymphovascular&#xD;
             invasion, and HG prostatic urethral involvement&#xD;
&#xD;
          -  Diagnosis with urothelial carcinoma (primary histologic subtype), localized to the&#xD;
             bladder, in the absence of nodal or other visceral metastases&#xD;
&#xD;
          -  Patients who have been indicated for induction intravesical BCG in&#xD;
             shared-decision-making with their primary urologist&#xD;
&#xD;
          -  Have not received acupuncture in the previous 3 months&#xD;
&#xD;
          -  Access to phone for study contacts&#xD;
&#xD;
          -  Willing and able to participate in trial activities&#xD;
&#xD;
          -  Platelets: 20,000/ uL or greater&#xD;
&#xD;
          -  Absolute neutrophil count (ANC): 500 cells/uL or greater&#xD;
&#xD;
          -  Able to understand and willing to sign written informed consent in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who have had intravesical or systemic chemotherapy or radiation therapy for&#xD;
             bladder cancer or for other malignancies prior to entering the study&#xD;
&#xD;
          -  Subjects who are indicated to receive other intravesical agents or therapies&#xD;
             concurrently with BCG will be excluded&#xD;
&#xD;
          -  Subjects who have muscle-invasive bladder cancer, radiographic evidence of lymph node&#xD;
             metastases or metastatic disease involving other organs including brain metastases&#xD;
&#xD;
          -  Patients with predominant histology other than urothelial carcinoma of the bladder who&#xD;
             would not otherwise be considered candidates for BCG&#xD;
&#xD;
          -  BCG is contraindicated in:&#xD;
&#xD;
               -  Patients who are pregnant or lactating&#xD;
&#xD;
               -  Patients with active tuberculosis&#xD;
&#xD;
               -  Immunosuppressed patients with congenital or acquired immune deficiency, whether&#xD;
                  due to concurrent disease (e.g. acquired immunodeficiency syndrome [AIDS],&#xD;
                  lymphoma, leukemia), concomitant cancer therapy (cytotoxic drugs, radiation), or&#xD;
                  immunosuppressive therapy (e.g. corticosteroids, disease-modifying anti-rheumatic&#xD;
                  drugs [DMARDs])&#xD;
&#xD;
               -  Symptomatic urinary tract infection&#xD;
&#xD;
               -  Febrile illness&#xD;
&#xD;
               -  Patients requiring chronic treatment with certain antibiotics that may interfere&#xD;
                  with the effectiveness of BCG&#xD;
&#xD;
               -  Any previous allergies or severe reactions to BCG&#xD;
&#xD;
          -  Not pregnant or trying to become pregnant. Acupuncture points included in the protocol&#xD;
             are contraindicated with pregnancy&#xD;
&#xD;
          -  Does not have a pacemaker. There is potential of electrostimulation interfering with&#xD;
             the operation and function of pacemakers&#xD;
&#xD;
          -  Patients requiring chronic treatment with certain antibiotics that may interfere with&#xD;
             the effectiveness of BCG. Fluoroquinolone therapy may decrease the efficacy of&#xD;
             intravesical BCG. Antibiotic therapy for ongoing treatment of active tuberculosis will&#xD;
             decrease the efficacy of intravesical BCG&#xD;
&#xD;
          -  Uncontrolled or concurrent illness including, but not limited to, ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, or psychiatric illness/social situations that would limit compliance with&#xD;
             study requirements&#xD;
&#xD;
          -  Pregnant women are excluded. Acupuncture points included in the protocol are&#xD;
             contraindicated with pregnancy and BCG is contraindicated in pregnancy&#xD;
&#xD;
          -  Pacemaker. Patients with pacemakers are restricted due to the potential of&#xD;
             electrostimulation interfering with a pacemakers operation&#xD;
&#xD;
          -  Platelets: &lt; 20,000/ uL. Risk of bleeding with acupuncture&#xD;
&#xD;
          -  ANC: &lt; 500 cells/uL. Risk of infection with acupuncture&#xD;
&#xD;
          -  Received acupuncture in the previous 3 months. Acupuncture treatment effects persist&#xD;
             after a course of treatment, previous exposure to the intervention has the potential&#xD;
             to affect the baseline data for treatment and control arms&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sarah P. Psutka</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fred Hutch/University of Washington Cancer Consortium</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fred Hutch/University of Washington Cancer Consortium</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>November 23, 2022</last_update_submitted>
  <last_update_submitted_qc>November 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Urinary Bladder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Transitional Cell</mesh_term>
    <mesh_term>Carcinoma in Situ</mesh_term>
    <mesh_term>Non-Muscle Invasive Bladder Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pharmaceutical Solutions</mesh_term>
    <mesh_term>BCG Vaccine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 9, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/19/NCT04496219/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>August 15, 2023</submitted>
    <returned>September 12, 2023</returned>
  </pending_results>
  <!-- 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/NCT04496219
org study id: RG1007421
secondary id: P30CA015704
secondary id: NCI-2020-05021
secondary id: 10544
nct id: NCT04496219
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: Yes
This phase II trial studies the safety and feasibility of utilizing acupuncture in patients
      with high-risk bladder cancer that has not spread to the surrounding muscle (non-muscle
      invasive) undergoing treatment with Intravesical BCG. BCG is a weakened form of the bacterium
      Mycobacterium bovis that does not cause disease. It is used in a solution to stimulate the
      immune system in the treatment of bladder cancer. Unfortunately, many patients experience
      side effects such as pelvic pain, painful urination, severe urgency, frequency, urge
      incontinence, need to urinate at night, and/or infectious complications. These side effects
      may cause patients to delay or stop BCG treatment. Acupuncture is a medical intervention in
      which fine metallic needles are inserted into anatomical locations of the body to stimulate
      the peripheral and the central nervous system. Giving acupuncture before each intravesical
      BCG treatment may help to reduce the side effects of intravesical BCG, and help patients
      complete treatment. Specific outcomes of interest include acceptability to patients, effect
      of acupuncture on intravesical BCG-related side effects, and adverse events associated with
      acupuncture.
OUTLINE: Patients are randomized to 1 of 2 arms.

      ARM I: Patients undergo acupuncture therapy and receive BCG via intravesical injection on
      days 1, 8, 15, 22, 29, and 36 in the absence of unacceptable toxicity. Patients also receive
      standard of care symptom management.

      ARM II: Patients receive BCG via intravesical injection on days 1, 8, 15, 22, 29, and 36 in
      the absence of unacceptable toxicity. Patients also receive standard of care symptom
      management. Patients may undergo acupuncture therapy after completion of intravesical BCG
      therapy.

      After completion of study, patients are followed up at 1 week.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Trial recruitment (proportion enrolled versus eligible, reason for not enrolling)
time frame: Up to 1 week after completion of treatment
description: Will be described via qualitative report.
measure: Trial retention (proportion retained versus all enrolled, reason for not completing)
time frame: Baseline, up to 1 week after completion of treatment
description: Will be described via qualitative report. Successful retention is defined as continued participation within the trial until 1 week following completion of induction.
measure: Protocol adherence (proportion adhered versus all enrolled, specifics for how protocol was not followed and why)
time frame: Up to 1 week after completion of treatment
description: Will be described via qualitative report. Protocol adherence is defined as completion of the acupuncture interventions and follow-up surveys if randomized to the acupuncture arm or completion of the follow-up surveys if randomized to the control arm.
measure: Patient satisfaction
time frame: At 3 weeks and after completion of treatment
description: Patients' responses to the Cancer Care Satisfaction survey at 3 weeks and at the conclusion of induction Bacillus Calmette-Guerin (BCG) between two arms will be compared using t-test.
measure: Clinic staff's responses to surveys
time frame: Up to 1 week after completion of treatment
description: Clinic staff's responses to surveys assessing the healthcare burden of this protocol and time spent undergoing the acupuncture therapy for the experimental arm will be described via qualitative report
measure: Incidence of adverse events
time frame: Up to 1 week after completion of treatment
description: Adverse events associated with acupuncture therapy in the experimental arm will be described via qualitative report.
measure: BCG instillation adherence (out of a possible planned six treatments)
time frame: Up to 1 week after completion of treatment
description: BCG instillation adherence (out of a possible planned six treatments (successful adherence defined as the number of successfully administered BCG instillations (of a possible 6 total), treatment interruptions (defined as number of weeks that a BCG instillation was delayed), weeks missed (measured as any vs none, and total weeks that BCG was not administered of the planned 6 weekly induction doses of intravesical BCG), intravesical BCG dwell times (measured in minutes), and requirement for dose reductions (measured as yes/no) between the acupuncture and control arms will be compared via t-test and chi-square as appropriate.
measure: Bladder and bowel symptoms as self reported by patients
time frame: From week 1 to week 6 of treatment
description: Compare the responses of patients in the experimental and control arms to the European Organization for Research and Treatment of Cancer - Non-Muscle Invasive Bladder Cancer 24 (EORTC-NMIBC24) symptom index, which was specifically designed to assess bladder and bowel symptoms for patients with NMIBC including assessments of impact of intravesical therapy.
measure: Quality of life: EORTC-QLQ-C30
time frame: From week 1 to week 6 of treatment
description: Assessed using the EORTC Health and Quality of Life Rating Scale (EORTC-QLQ-C30).
measure: Median weekly pill counts of medications prescribed for the management of BCG-related side effects, standardized by dosage across medication types
time frame: Up to 1 week after completion of treatment
description: Will be compared via Wilcoxon rank sum test.
arm group label: Arm I (acupuncture, BCG)
arm group type: Experimental
description: Patients undergo acupuncture therapy and receive BCG via intravesical injection on days 1, 8, 15, 22, 29, and 36 in the absence of unacceptable toxicity. Patients also receive standard of care symptom management.
arm group label: Arm II (BCG, standard of care)
arm group type: Active Comparator
description: Patients receive BCG via intravesical injection on days 1, 8, 15, 22, 29, and 36 in the absence of unacceptable toxicity. Patients also receive standard of care symptom management. Patients may undergo acupuncture therapy after completion of intravesical BCG therapy.
intervention type: Device
intervention name: Acupuncture Therapy
description: Undergo acupuncture therapy
arm group label: Arm I (acupuncture, BCG)
arm group label: Arm II (BCG, standard of care)
other name: Acupuncture
intervention type: Biological
intervention name: BCG Solution
description: Given by intravesical injection
arm group label: Arm I (acupuncture, BCG)
arm group label: Arm II (BCG, standard of care)
other name: Bacillus Calmette Guerin Solution
other name: Bacillus Calmette-Guerin Solution
other name: TICE BCG Solution
intervention type: Other
intervention name: Best Practice
description: Receive standard of care symptom management
arm group label: Arm I (acupuncture, BCG)
arm group label: Arm II (BCG, standard of care)
other name: standard of care
other name: standard therapy
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Arm I (acupuncture, BCG)
arm group label: Arm II (BCG, standard of care)
other name: Quality of Life Assessment
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Arm I (acupuncture, BCG)
arm group label: Arm II (BCG, standard of care)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sarah P. Psutka
role: Principal Investigator
affiliation: Fred Hutch/University of Washington Cancer Consortium
facility: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Urinary Bladder Neoplasms
mesh term: Carcinoma, Transitional Cell
mesh term: Carcinoma in Situ
mesh term: Non-Muscle Invasive Bladder Neoplasms
mesh term: Pharmaceutical Solutions
mesh term: BCG Vaccine
sharing ipd: No
provided document: 
submitted: August 15, 2023
returned: September 12, 2023