<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/NCT04403802</url>
  </required_header>
  <id_info>
    <org_study_id>IIT2019-08-ASHER-VOXXSOCK</org_study_id>
    <nct_id>NCT04403802</nct_id>
  </id_info>
  <brief_title>Voxx Human Performance Technology Socks for Chemotherapy-Induced Peripheral Neuropathy</brief_title>
  <official_title>IIT2019-08-ASHER-VOXXSOCK Voxx Human Performance Technology Socks for Chemotherapy-Induced Peripheral Neuropathy: A Double Blind, Randomized, Controlled Crossover Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Arash Asher, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>VoxxLife</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cedars-Sinai Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a double blind, randomized, crossover pilot study of Voxx Human Performance&#xD;
      Technology Socks versus placebo socks for the treatment of chemotherapy-induced peripheral&#xD;
      neuropathy in patients with cancer. Patients will be randomized 1:1 to one of the following&#xD;
      regimens:&#xD;
&#xD;
        -  Arm A: Continuous wear of Voxx Human Performance Technology Socks for 2 weeks, followed&#xD;
           by continuous wear of placebo socks for 2 weeks (separated by a 2-week washout period)&#xD;
&#xD;
        -  Arm B: Continuous wear of placebo socks for 2 weeks, followed by continuous wear of Voxx&#xD;
           Human Performance Technology Socks for 2 weeks (separated by a 2-week washout period)&#xD;
&#xD;
      Patients will be evaluated at three time points using an objective neuropathy assessment as&#xD;
      well as self-report questionnaires assessing chemotherapy-induced peripheral neuropathy,&#xD;
      quality of life, and cancer-related symptoms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 16, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in subjective measurement of chemotherapy-induced peripheral neuropathy</measure>
    <time_frame>6 weeks</time_frame>
    <description>Impact on chemotherapy-induced peripheral neuropathy will be subjectively measured by changes in scores on the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale. The minimum value is 0 and maximum value is 44, and a lower score means a better outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in objective measurement of chemotherapy-induced peripheral neuropathy (score on the Modified Total Neuropathy Scale)</measure>
    <time_frame>6 weeks</time_frame>
    <description>Impact on chemotherapy-induced peripheral neuropathy will be objectively measured by changes in scores on the Total Neuropathy Scale clinical. The minimum value is 0 and maximum value is 24, and a lower score means a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in objective measurement of chemotherapy-induced peripheral neuropathy (score on the Timed Up and Go test)</measure>
    <time_frame>6 weeks</time_frame>
    <description>Impact on chemotherapy-induced peripheral neuropathy will be objectively measured by changes in scores on the Timed Up and Go test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life measurement</measure>
    <time_frame>6 weeks</time_frame>
    <description>Impact on quality of life will be measured by the changes in scores on the Patient-Reported Outcomes Measurement Information System 29. The minimum value is 50 and maximum value is 110, and a lower score means a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cancer-related symptom experience</measure>
    <time_frame>6 weeks</time_frame>
    <description>Impact on cancer-related symptom experience will be measured by changes in scores on the Edmonton Symptom Assessment Scale. The minimum value is 0 and maximum value is 100, and a lower score means a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility of Voxx Socks use</measure>
    <time_frame>6 weeks</time_frame>
    <description>Feasibility will be measured by the number of hours the socks are worn, as recorded in the patient's daily sock diary.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Neuropathy;Peripheral</condition>
  <condition>Chemotherapy-induced Peripheral Neuropathy</condition>
  <condition>Neuropathy</condition>
  <arm_group>
    <arm_group_label>Arm A: Voxx socks followed by placebo socks</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Continuous wear of Voxx Human Performance Technology Socks for 2 weeks, followed by continuous wear of placebo socks for 2 weeks (separated by a 2-week washout period)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B: Placebo socks followed by Voxx socks</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Continuous wear of placebo socks for 2 weeks, followed by continuous wear of Voxx Human Performance Technology Socks for 2 weeks (separated by a 2-week washout period)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Voxx Human Performance Technology Socks</intervention_name>
    <description>Voxx Human Performance Technology Socks are commercially-available socks that are drug and electrical free. The Voxx Human Performance Technology proprietary pattern is woven into a sock that is made of 70% cotton, 25% polyester, 3% spandex, and 2% nylon.&#xD;
Prior to the 2-week treatment window, patients will be provided with 6 pairs of Voxx Human Performance Technology socks. Patients will be asked to wear the socks continuously during both waking and sleeping hours, except when showering, bathing, or swimming.</description>
    <arm_group_label>Arm A: Voxx socks followed by placebo socks</arm_group_label>
    <arm_group_label>Arm B: Placebo socks followed by Voxx socks</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Placebo Socks</intervention_name>
    <description>Placebo socks are identical to the Voxx Human Performance Technology socks but do not include the Voxx Human Performance Technology pattern woven into the sock. Placebo socks are made of the same fabric as Voxx Human Performance Technology socks and are drug and electrical free.&#xD;
Prior to the 2-week treatment window, patients will be provided with 6 pairs of placebo socks. Patients will be asked to wear the socks continuously during both waking and sleeping hours, except when showering, bathing, or swimming.</description>
    <arm_group_label>Arm A: Voxx socks followed by placebo socks</arm_group_label>
    <arm_group_label>Arm B: Placebo socks followed by Voxx socks</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with cancer, stage 1-4.&#xD;
&#xD;
          -  Completed taxane- or platinum-based chemotherapy, vinca alkaloids, or bortezomib at&#xD;
             least three months (90 days) ago. Current use of anti-estrogen therapy, Herceptin, or&#xD;
             PARP inhibitors is okay.&#xD;
&#xD;
          -  Clinical diagnosis of chemotherapy-induced peripheral neuropathy by clinician. This&#xD;
             will be based on symptom history (paresthesias, dysesthesias, allodynia), loss of deep&#xD;
             tendon reflexes, decreased vibratory sensation, or the presence of symmetrical&#xD;
             stocking-glove numbness or paresthesias beginning after neurotoxic chemotherapy.&#xD;
&#xD;
          -  Self-reported average neuropathic pain score of at least 4 on a 10-point scale over&#xD;
             the past 1 month.&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Concomitant use of analgesics is permitted if the dose has been stable for at least 2&#xD;
             weeks prior to study enrollment (no new analgesics have been added, discontinued, or&#xD;
             changed in the 2 weeks prior to randomization).&#xD;
&#xD;
          -  Written informed consent obtained from subject and ability for subject to comply with&#xD;
             the requirements of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Syphilis, alcoholic neuropathy, diabetic neuropathy, neurological disorders, brain&#xD;
             injury, or stroke, as assessed by the treating physician.&#xD;
&#xD;
          -  Neuropathy related to abnormal thyroid stimulating hormone or cobalamin levels as&#xD;
             assessed by treating physician.&#xD;
&#xD;
          -  Current severe depression, suicidal ideation, bipolar disease, alcohol abuse, or major&#xD;
             eating disorder, as assessed by the treating physician.&#xD;
&#xD;
          -  Currently participating in another chemotherapy-induced peripheral neuropathy-targeted&#xD;
             program or trial.&#xD;
&#xD;
          -  Participated in a non-pharmacologic therapy specifically for the treatment of&#xD;
             chemotherapy-induced peripheral neuropathy, including Scrambler Therapy, mindfulness&#xD;
             meditation, or other mind-body activities within 14 days (2 weeks) prior to&#xD;
             randomization.&#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_contact>
    <last_name>Chris Waring</last_name>
    <phone>920-217-0317</phone>
    <email>Christopher.Waring@cshs.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Cancer Clinical Trials Office</last_name>
    <phone>310-423-2133</phone>
    <email>Cancer.Trials.Info@cshs.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cedars Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christopher Waring</last_name>
      <phone>920-217-0317</phone>
      <email>Christopher.Waring@cshs.org</email>
    </contact>
    <investigator>
      <last_name>Arash Asher, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CS Cancer at the Hunt Cancer Center</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90505</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sarah Valdez</last_name>
      <phone>310-750-3300</phone>
      <phone_ext>73422</phone_ext>
      <email>Sarah.Valdez@tmphysicians.com</email>
    </contact>
    <investigator>
      <last_name>David Chan, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Vanessa Dickey, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hugo Hool, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Syed Jilani, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Thomas Lowe, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Swati Sikaria, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>May 4, 2023</last_update_submitted>
  <last_update_submitted_qc>May 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cedars-Sinai Medical Center</investigator_affiliation>
    <investigator_full_name>Arash Asher, MD</investigator_full_name>
    <investigator_title>Director, Cancer Rehabilitation &amp; Survivorship</investigator_title>
  </responsible_party>
  <keyword>Chemo-induced Peripheral Neuropathy</keyword>
  <keyword>Voxx Socks</keyword>
  <keyword>Voxx Human Performance Technology</keyword>
  <keyword>Voxx HPT</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>


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/NCT04403802
org study id: IIT2019-08-ASHER-VOXXSOCK
nct id: NCT04403802
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
This is a double blind, randomized, crossover pilot study of Voxx Human Performance
      Technology Socks versus placebo socks for the treatment of chemotherapy-induced peripheral
      neuropathy in patients with cancer. Patients will be randomized 1:1 to one of the following
      regimens:

        -  Arm A: Continuous wear of Voxx Human Performance Technology Socks for 2 weeks, followed
           by continuous wear of placebo socks for 2 weeks (separated by a 2-week washout period)

        -  Arm B: Continuous wear of placebo socks for 2 weeks, followed by continuous wear of Voxx
           Human Performance Technology Socks for 2 weeks (separated by a 2-week washout period)

      Patients will be evaluated at three time points using an objective neuropathy assessment as
      well as self-report questionnaires assessing chemotherapy-induced peripheral neuropathy,
      quality of life, and cancer-related symptoms.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Investigator)
measure: Change in subjective measurement of chemotherapy-induced peripheral neuropathy
time frame: 6 weeks
description: Impact on chemotherapy-induced peripheral neuropathy will be subjectively measured by changes in scores on the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale. The minimum value is 0 and maximum value is 44, and a lower score means a better outcome.
measure: Change in objective measurement of chemotherapy-induced peripheral neuropathy (score on the Modified Total Neuropathy Scale)
time frame: 6 weeks
description: Impact on chemotherapy-induced peripheral neuropathy will be objectively measured by changes in scores on the Total Neuropathy Scale clinical. The minimum value is 0 and maximum value is 24, and a lower score means a better outcome.
measure: Change in objective measurement of chemotherapy-induced peripheral neuropathy (score on the Timed Up and Go test)
time frame: 6 weeks
description: Impact on chemotherapy-induced peripheral neuropathy will be objectively measured by changes in scores on the Timed Up and Go test.
measure: Change in quality of life measurement
time frame: 6 weeks
description: Impact on quality of life will be measured by the changes in scores on the Patient-Reported Outcomes Measurement Information System 29. The minimum value is 50 and maximum value is 110, and a lower score means a better outcome.
measure: Change in cancer-related symptom experience
time frame: 6 weeks
description: Impact on cancer-related symptom experience will be measured by changes in scores on the Edmonton Symptom Assessment Scale. The minimum value is 0 and maximum value is 100, and a lower score means a better outcome.
measure: Feasibility of Voxx Socks use
time frame: 6 weeks
description: Feasibility will be measured by the number of hours the socks are worn, as recorded in the patient's daily sock diary.
arm group label: Arm A: Voxx socks followed by placebo socks
arm group type: Experimental
description: Continuous wear of Voxx Human Performance Technology Socks for 2 weeks, followed by continuous wear of placebo socks for 2 weeks (separated by a 2-week washout period)
arm group label: Arm B: Placebo socks followed by Voxx socks
arm group type: Experimental
description: Continuous wear of placebo socks for 2 weeks, followed by continuous wear of Voxx Human Performance Technology Socks for 2 weeks (separated by a 2-week washout period)
intervention type: Device
intervention name: Voxx Human Performance Technology Socks
description: Voxx Human Performance Technology Socks are commercially-available socks that are drug and electrical free. The Voxx Human Performance Technology proprietary pattern is woven into a sock that is made of 70% cotton, 25% polyester, 3% spandex, and 2% nylon.
Prior to the 2-week treatment window, patients will be provided with 6 pairs of Voxx Human Performance Technology socks. Patients will be asked to wear the socks continuously during both waking and sleeping hours, except when showering, bathing, or swimming.
arm group label: Arm A: Voxx socks followed by placebo socks
arm group label: Arm B: Placebo socks followed by Voxx socks
intervention type: Device
intervention name: Placebo Socks
description: Placebo socks are identical to the Voxx Human Performance Technology socks but do not include the Voxx Human Performance Technology pattern woven into the sock. Placebo socks are made of the same fabric as Voxx Human Performance Technology socks and are drug and electrical free.
Prior to the 2-week treatment window, patients will be provided with 6 pairs of placebo socks. Patients will be asked to wear the socks continuously during both waking and sleeping hours, except when showering, bathing, or swimming.
arm group label: Arm A: Voxx socks followed by placebo socks
arm group label: Arm B: Placebo socks followed by Voxx socks
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chris Waring
phone: 920-217-0317
email: Christopher.Waring@cshs.org
last name: Cancer Clinical Trials Office
phone: 310-423-2133
email: Cancer.Trials.Info@cshs.org
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Cedars-Sinai Medical Center
investigator full name: Arash Asher, MD
investigator title: Director, Cancer Rehabilitation & Survivorship
mesh term: Peripheral Nervous System Diseases