xml: <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/NCT05980169</url>
    </required_header>
    <id_info>
      <org_study_id>GCC-23-021</org_study_id>
      <nct_id>NCT05980169</nct_id>
    </id_info>
    <brief_title>The Effect of Low Frequency Soundwave Stimulation on Chemotherapy Induced Peripheral Neuropathy</brief_title>
    <official_title>The Effect of Low Frequency Soundwave Stimulation on Chemotherapy Induced Peripheral Neuropathy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Augusta University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Augusta University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to assess the efficacy of SensoniQ® Treatment Station in&#xD;
        preventing or reducing chemotherapy induced peripheral neuropathy (CIPN) in patients&#xD;
        receiving frontline carboplatin and paclitaxel chemotherapy for a gynecologic malignancy.&#xD;
        This study will also assess the improvement of CIPN in patients who have previously received&#xD;
        carboplatin and paclitaxel therapy with persistent Grade 2 or worse neuropathy.&#xD;
  &#xD;
        The main questions this clinical trial aims to answer are:&#xD;
  &#xD;
          1. To investigate the efficacy of SensoniQ® Treatment Station on the prevention or&#xD;
             reduction of CIPN in gynecologic oncology patients receiving front line carboplatin and&#xD;
             paclitaxel.&#xD;
  &#xD;
          2. To investigate the efficacy of SensoniQ® Treatment Station on the improvement of&#xD;
             existing CIPN in patients who previously received chemotherapy with carboplatin and&#xD;
             paclitaxel for a gynecologic malignancy&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Chemotherapy induced neuropathy (CIPN) is a common side effect in patients undergoing&#xD;
        treatment for gynecologic malignancies. The most common treatment is a combination of&#xD;
        paclitaxel and carboplatin. A previous analysis of these patients show that 71% experience&#xD;
        chemo induced peripheral with neuropathy with 30% experiencing Grade 2 and 32% experiencing&#xD;
        Grade 3. There is currently no intervention to prevent CIPN and only one medication,&#xD;
        duloxetine, is recommended as treatment based on ASCO guidelines.&#xD;
  &#xD;
        The SensoniQ® Treatment Station is a chemotherapy chair with multiple transducers that&#xD;
        release low- frequency sound waves to different points on the body in a preset frequency,&#xD;
        distribution and time during a chemotherapy infusion. Previous investigational studies using&#xD;
        SensoniQ® Treatment during chemotherapy infusion showed a reduction in neuropathy without any&#xD;
        additional side effects or complications.&#xD;
  &#xD;
        This study seeks to show patient response measured by questionnaires to SensoniQ® Treatment&#xD;
        and correlate with neurologic test findings to show reduced CIPN in patients undergoing&#xD;
        frontline chemotherapy with carboplatin and paclitaxel as well as improvement in patients&#xD;
        with existing CIPN. This treatment has the potential to change recommendations for prevention&#xD;
        of CIPN and improve adherence to treatment and quality of life.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2029</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>FACT/GOG-NTX &amp; EORTC QLQ-CIPN20</measure>
      <time_frame>18 months</time_frame>
      <description>Percent of patients reporting neuropathy based on post treatment Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity Questionnaire (FACT/GOG NTX) and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN Twenty Item Subscale (EORTC QLQ-CIPN20) scores (This primary outcome is specific to Cohort A)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>FACT/GOG-NTX &amp; EORTC QLQ CIPN-20</measure>
      <time_frame>18 months</time_frame>
      <description>Percent reduction in neuropathy based on post treatment FACT/GOG NTX and EORTC QLQ-CIPN 20 score compared to pretreatment score (This primary outcome measure is specific to Cohort B).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Neurologic Exams</measure>
      <time_frame>18 months</time_frame>
      <description>Change in score from pretreatment to post-treatment neurologic exams (Specific to both cohorts A &amp; B).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>FACT/GOG NTX &amp; EORTC QLQ-CIPN 20</measure>
      <time_frame>18 months</time_frame>
      <description>Direct correlation of FACT/GOG NTX and EORTC QLQ-CIPN 20 scores to non-invasive neurologic scores (Specific to both cohorts A &amp; B).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety &amp; Tolerability</measure>
      <time_frame>18 months</time_frame>
      <description>Safety and tolerability based on AEs, SAEs, &amp; vital signs (Specific to both cohorts A &amp; B).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dose of chemotherapy</measure>
      <time_frame>18 months</time_frame>
      <description>Total dose of chemotherapy (Specific to cohort A).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Response Rate</measure>
      <time_frame>18 months</time_frame>
      <description>ORR at 6 months post treatment per FACT/GOB NTX and EORTC QLQ-CIPN 20 scores and non-invasive neurologic test scores (specific to cohort B).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>FACT/GOG NTX &amp; EORTC QLQ-CIPN20 maximum reduction</measure>
      <time_frame>18 months</time_frame>
      <description>Assess FACT/GOG NTX and EORTC QLQ-CIPN20 scores at each visit to determine the treatment number at which maximum reduction from baseline score is reported (specific to cohort B).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment Completion</measure>
      <time_frame>18 months</time_frame>
      <description>Time for treatment completion (Specific to cohort A).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Gynecologic Cancer</condition>
    <condition>Neuropathy;Peripheral</condition>
    <arm_group>
      <arm_group_label>Cohort A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In this arm, patients with newly diagnosed gynecologic cancer starting chemotherapy treatment with carboplatin and paclitaxel will receive up to 8 cycles of SensoniQ treatment along with their chemotherapy (weekly or every 21 days depending on the regimen).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In this arm, gynecologic cancer patients with persistent neuropathy following treatment with carboplatin and paclitaxel will receive a 30 minute SensoniQ treatment twice weekly for 4 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>SensoniQ Treatment Station</intervention_name>
      <description>The SensoniQ® Treatment Station is a chemotherapy chair with multiple transducers that release low- frequency sound waves to different points on the body in a preset frequency, distribution and time during a chemotherapy infusion.</description>
      <arm_group_label>Cohort A</arm_group_label>
      <arm_group_label>Cohort B</arm_group_label>
      <other_name>Wave Chair</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria: Patients must meet all the following inclusion criteria to be eligible&#xD;
          for inclusion in the study:&#xD;
  &#xD;
            1. Patients must be age 18 or older.&#xD;
  &#xD;
            2. Histologically confirmed gynecologic malignancy.&#xD;
  &#xD;
            3. Eastern Cooperative Oncology Group performance status of 0 to 2.&#xD;
  &#xD;
            4. Be willing and able to participate in all required evaluations for the protocol&#xD;
  &#xD;
            5. Speak, read, and understand English&#xD;
  &#xD;
               Cohort A patients must have:&#xD;
  &#xD;
            6. Carboplatin and paclitaxel prescribed as first line treatment&#xD;
  &#xD;
          Cohort B patients must have:&#xD;
  &#xD;
          7. Received prior treatment with carboplatin and paclitaxel with a persistent CTCAE defined&#xD;
          Grade 2 or worse neuropathy&#xD;
  &#xD;
          -&#xD;
  &#xD;
          Exclusion Criteria: Patients with any of the following will not be included in the study:&#xD;
  &#xD;
            1. Current diagnosis of comorbidity causing neuropathy (including peripheral vascular&#xD;
               disease, lupus, Sjogren's syndrome, rheumatoid arthritis). Patients with diabetes may&#xD;
               participate if baseline exam is negative for neuropathy symptoms and HbA1c &lt; 7.&#xD;
  &#xD;
            2. Pregnant&#xD;
  &#xD;
            3. DVT diagnosed within 4 weeks prior to treatment&#xD;
  &#xD;
            4. Body weight greater 195kg&#xD;
  &#xD;
          Cohort A patients:&#xD;
  &#xD;
          6. Previous treatment with taxane therapy 7. Preexisting diagnosis of neuropathy 8.&#xD;
          Currently prescribed gabapentin, duloxetine or pregabalin&#xD;
  &#xD;
          Cohort B patients:&#xD;
  &#xD;
          9. Diagnosis of neuropathy prior to cancer treatment&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>This study protocol is specific to gynecological oncology studies. The study only applies to female patients.</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Marian S Johnson, MD</last_name>
      <phone>(706) 721-3992</phone>
      <email>MJOHNSON56@augusta.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>James T Sonnenberg, BS</last_name>
      <phone>9106192597</phone>
      <email>JSONNENBERG@AUGUSTA.EDU</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>James T Sonnenberg</name>
        <address>
          <city>Augusta</city>
          <state>Georgia</state>
          <zip>29607</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>James T Sonnenberg, BS</last_name>
        <phone>910-619-2597</phone>
        <email>JSONNENBERG@AUGUSTA.EDU</email>
      </contact>
      <contact_backup>
        <last_name>Eleanor Reeves, BS</last_name>
        <phone>706-721-0730</phone>
        <email>ereeves@augusta.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Marian S Johnson, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 10, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Chemotherapy</keyword>
    <keyword>Neuropathy</keyword>
    <keyword>Soundwave Stmiulation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Peripheral Nervous System Diseases</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05980169
  org study id: GCC-23-021
  nct id: NCT05980169
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  The goal of this clinical trial is to assess the efficacy of SensoniQ® Treatment Station in
        preventing or reducing chemotherapy induced peripheral neuropathy (CIPN) in patients
        receiving frontline carboplatin and paclitaxel chemotherapy for a gynecologic malignancy.
        This study will also assess the improvement of CIPN in patients who have previously received
        carboplatin and paclitaxel therapy with persistent Grade 2 or worse neuropathy.
  
        The main questions this clinical trial aims to answer are:
  
          1. To investigate the efficacy of SensoniQ® Treatment Station on the prevention or
             reduction of CIPN in gynecologic oncology patients receiving front line carboplatin and
             paclitaxel.
  
          2. To investigate the efficacy of SensoniQ® Treatment Station on the improvement of
             existing CIPN in patients who previously received chemotherapy with carboplatin and
             paclitaxel for a gynecologic malignancy
  Chemotherapy induced neuropathy (CIPN) is a common side effect in patients undergoing
        treatment for gynecologic malignancies. The most common treatment is a combination of
        paclitaxel and carboplatin. A previous analysis of these patients show that 71% experience
        chemo induced peripheral with neuropathy with 30% experiencing Grade 2 and 32% experiencing
        Grade 3. There is currently no intervention to prevent CIPN and only one medication,
        duloxetine, is recommended as treatment based on ASCO guidelines.
  
        The SensoniQ® Treatment Station is a chemotherapy chair with multiple transducers that
        release low- frequency sound waves to different points on the body in a preset frequency,
        distribution and time during a chemotherapy infusion. Previous investigational studies using
        SensoniQ® Treatment during chemotherapy infusion showed a reduction in neuropathy without any
        additional side effects or complications.
  
        This study seeks to show patient response measured by questionnaires to SensoniQ® Treatment
        and correlate with neurologic test findings to show reduced CIPN in patients undergoing
        frontline chemotherapy with carboplatin and paclitaxel as well as improvement in patients
        with existing CIPN. This treatment has the potential to change recommendations for prevention
        of CIPN and improve adherence to treatment and quality of life.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: FACT/GOG-NTX & EORTC QLQ-CIPN20
  time frame: 18 months
  description: Percent of patients reporting neuropathy based on post treatment Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity Questionnaire (FACT/GOG NTX) and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN Twenty Item Subscale (EORTC QLQ-CIPN20) scores (This primary outcome is specific to Cohort A)
  measure: FACT/GOG-NTX & EORTC QLQ CIPN-20
  time frame: 18 months
  description: Percent reduction in neuropathy based on post treatment FACT/GOG NTX and EORTC QLQ-CIPN 20 score compared to pretreatment score (This primary outcome measure is specific to Cohort B).
  measure: Neurologic Exams
  time frame: 18 months
  description: Change in score from pretreatment to post-treatment neurologic exams (Specific to both cohorts A & B).
  measure: FACT/GOG NTX & EORTC QLQ-CIPN 20
  time frame: 18 months
  description: Direct correlation of FACT/GOG NTX and EORTC QLQ-CIPN 20 scores to non-invasive neurologic scores (Specific to both cohorts A & B).
  measure: Safety & Tolerability
  time frame: 18 months
  description: Safety and tolerability based on AEs, SAEs, & vital signs (Specific to both cohorts A & B).
  measure: Dose of chemotherapy
  time frame: 18 months
  description: Total dose of chemotherapy (Specific to cohort A).
  measure: Overall Response Rate
  time frame: 18 months
  description: ORR at 6 months post treatment per FACT/GOB NTX and EORTC QLQ-CIPN 20 scores and non-invasive neurologic test scores (specific to cohort B).
  measure: FACT/GOG NTX & EORTC QLQ-CIPN20 maximum reduction
  time frame: 18 months
  description: Assess FACT/GOG NTX and EORTC QLQ-CIPN20 scores at each visit to determine the treatment number at which maximum reduction from baseline score is reported (specific to cohort B).
  measure: Treatment Completion
  time frame: 18 months
  description: Time for treatment completion (Specific to cohort A).
  arm group label: Cohort A
  arm group type: Experimental
  description: In this arm, patients with newly diagnosed gynecologic cancer starting chemotherapy treatment with carboplatin and paclitaxel will receive up to 8 cycles of SensoniQ treatment along with their chemotherapy (weekly or every 21 days depending on the regimen).
  arm group label: Cohort B
  arm group type: Experimental
  description: In this arm, gynecologic cancer patients with persistent neuropathy following treatment with carboplatin and paclitaxel will receive a 30 minute SensoniQ treatment twice weekly for 4 weeks.
  intervention type: Device
  intervention name: SensoniQ Treatment Station
  description: The SensoniQ® Treatment Station is a chemotherapy chair with multiple transducers that release low- frequency sound waves to different points on the body in a preset frequency, distribution and time during a chemotherapy infusion.
  arm group label: Cohort A
  arm group label: Cohort B
  other name: Wave Chair
  criteria: 
  gender: Female
  gender based: Yes
  gender description: This study protocol is specific to gynecological oncology studies. The study only applies to female patients.
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Marian S Johnson, MD
  phone: (706) 721-3992
  email: MJOHNSON56@augusta.edu
  last name: James T Sonnenberg, BS
  phone: 9106192597
  email: JSONNENBERG@AUGUSTA.EDU
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Peripheral Nervous System Diseases