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Wearable Focal Vibration for Chemotherapy-Induced Peripheral Neuropathy

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ClinicalTrials.gov Identifier: NCT04959929
Recruitment Status : Recruiting
First Posted : July 13, 2021
Last Update Posted : March 6, 2024
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma

Study Description
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Brief Summary:
This study will perform an early Phase I feasibility study with single-arm, double-baseline repeated measured design. The investigators will test the feasibility of using focal vibration to improve symptoms of persistent CIPN.

Condition or disease Intervention/treatment Phase
Chemotherapy-induced Peripheral Neuropathy Device: Focal vibration therapy Not Applicable

Detailed Description:
This is an initial Phase I single-site, single-arm, double-baseline repeated measures feasibility study of wearable focal vibration (FV with Myovolt) for persistent chemotherapy-induced peripheral neuropathy. We will enroll up to 15 cancer survivors who are cancer-free and meet all other inclusion/ exclusion criteria, including CIPN symptoms at least 3 months after final chemotherapy infusion. Participants will undergo baseline assessments (V1) of questionnaires and performance tests, and may repeat these tests within a few days as a double-baseline (V2). In addition, they complete 7-days of baseline symptom monitoring by diary before starting 6 weeks of daily at-home therapy with a Myovolt wearable FV device. A study coach will check in by phone or video calls during the intervention period. Participants undergo post-testing immediately after the 6-week intervention (V3), and after another 6 weeks without FV (V4). In total, participants attend 3-4 onsite study visits, a 6-week intervention period with weekly remote check-in contact from the study team, and a 6-week intervention-free follow-up period with at least one remote check-in. Participants will keep a provided daily symptom diary during the primary study period (i.e., 6 weeks), and at least weekly in the 6-week follow-up period.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All participants will be assigned to a single group that will receive focal vibration therapy using Myovolt.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Wearable Focal Vibration for Chemotherapy-Induced Peripheral Neuropathy
Actual Study Start Date : February 9, 2023
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : December 31, 2024

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Focal vibration therapy
Myovolt delivers vibration with a frequency between 50-80 Hz. Myovolt intensity will be set to ~up to 2X the participant's initial Myovolt perception threshold. If the stimulation does not feel strong, the participant will be asked to manually increase the intensity until it feels strong but comfortable.
 Device: Focal vibration therapy
Myovolt is a wearable rehabilitative device that delivers vibration to the region of the body where the motors are worn. Participants are asked to apply the vibration to specific leg locations twice a day, for about 30 minutes at a time, and to record their response using a provided log. They may be asked to try applying the device at different location or using different vibration parameters (pulse frequency or intensity).
Other Name: Myovolt


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility of enrollment [ Time Frame: Baseline ]
    Percent of interested individuals who enrolled.

  2. Adherence to Myovolt focal vibration [ Time Frame: After 6-week intervention ]
    Number of completed days and sessions of Number of days (or sessions) the intervention was worn, as a percentage of the number of days (or sessions) the device was prescribed.


Secondary Outcome Measures :
  1. Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-12 (FACT-GOG/NTX-12) Symptom Inventory [ Time Frame: Change from Baseline after 6-week Intervention ]
    The FACT-GOG/Ntx-12 is a composite measure of CIPN symptoms and functional impairments and related quality of life, scored from 0 to 48 where a higher score indicates worse neuropathy symptoms.

  2. Neuropathy Total Symptom Score-6 (NTSS-6) [ Time Frame: Change from Baseline after 6-week Intervention ]
    The NTSS-6 rates neuropathic symptoms (severity and frequency) in 6-categories. Scores range from 0 to 21.96, and higher scores indicate higher symptom burden.

  3. Patient Neurotoxicity Questionnaire (PNQ) [ Time Frame: Change from Baseline after 6-week Intervention ]
    The PNQ grades the extent of sensory and motor neuropathy in cancer cohorts scored from grade A (no neuropathy, also Grade 0) to grade E (severe neuropathy, also Grade 4) for both sensory and motor symptoms.

  4. Global Rating of Change (GROC) scale [ Time Frame: After 6-week withdrawal period ]
    The GROC scale is a universal clinical outcome providing a simple but comprehensive "umbrella" patient-perspective of change with scores ranging from -5 (very much worse) to 0 (unchanged) to +5 (completely recovered).

  5. Long-term retention [ Time Frame: After 6-week withdrawal period ]
    Number of enrolled individuals retained for long-term follow-up(after 6-week withdrawal period), and reasons for loss to follow-up, when available.

  6. Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-12 (FACT-GOG/NTX-12) Physical Well-Being Subscale [ Time Frame: Change from Baseline after 6-week Intervention ]
    The FACT-GOG/Ntx-12 PWB subscale is a patient-report measure of physical symptoms and function. Scored from 0 to 28, higher scores indicate better well-being.

  7. Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-12 (FACT-GOG/NTX-12) Functional Well-Being Subscale [ Time Frame: Change from Baseline after 6-week Intervention ]
    The FACT-GOG/Ntx-12 FWB subscale is a patient-report measure of functional well-being with questions about work, leisure and sleep, and a summary quality of life(QoL)rating. Scores range from 0 to 28, higher scores indicate better well-being and QoL.

  8. Manual Muscle Testing (MMT) of Toes [ Time Frame: Change from Baseline after 6-week Intervention ]
    MMT assesses muscle strength by an assessor applying pressure against the toes as the participant lifts or curls their toes and is rated from 0 (weakest) to 5 (strongest).

  9. Toe Strength using a quantifiable toe measurement device [ Time Frame: Change from Baseline after 6-week Intervention ]
    The toe strength quantifiable toe measurement device measures toe strength by reading force measurements when participants sit with foot strapped on a portable base of a load-cell prototype device of PI Dr. Hile and her team, with toe inserted into housing against which they pull up for a few seconds, or press down.

  10. Vibration Perception Threshold using Biothesiometer [ Time Frame: Change from Baseline after 6-week Intervention ]
    Vibratory threshold will be measured by a non-invasive vibrating probe (biothesiometer) placed on the skin. Vibration intensity is measured in frequency where the frequency is increased until the participant reports feeling it (eyes closed) from 0 to 50 Hz.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years or older
  • Cancer patients with current symptoms of chemotherapy induced peripheral neuropathy affecting the feet, persisting for at least 3 months after completion of chemotherapy, and not substantially improving in recent weeks. The CIPN must be painful, or severe enough to interfere with function, activities, or participation (generally NCI-CTCAE Grade II)
  • Clinically stable to participate in study assessments and the intervention (at a minimum, able to stand independently from a chair and walk household distances without help from another person)
  • Able to read and speak English, give a voluntary written consent
  • Sufficient cognition to consent, confirmed by recall of key study points
  • Use of pain medications (opioids, anti-convulsants, and antidepressants) must be stable in the two weeks prior to study enrollment, and the participant must agree to avoid significant changes in pain medication regimen during the period of active study participation, and to notify the study team if medications change

Exclusion Criteria:

  • Neuropathy (known or suspected) of any etiology other than chemotherapy or diabetes (for example, due to alcohol, vitamin deficiency, autoimmune disorder, CMT, idiopathic
  • Unsafe/unable to self-apply the focal vibration intervention for any reason (for example, insufficient hand dexterity or cognitive executive function
  • Recent or fluctuating musculoskeletal injury or lesion that would impact physical performance
  • Lower limb deficiency/amputations
  • Pregnant, or planning to get pregnant in the next 6 months. Pre-menopausal females who enroll agree to notify the study team as soon as possible should they become pregnant
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04959929


Contacts
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Contact: Josiah Rippetoe, BS 4052711529 josiah-rippetoe@ouhsc.edu
Contact: Abby Cha, BS 4052711529 abby-cha@ouhsc.edu

Locations
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United States, Oklahoma
Stephenson Cancer Center, OU Health Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Elizabeth Hile, PhD    405-271-1529    elizabeth-hile@ouhsc.edu   
Sub-Investigator: Kathleen Moore, PhD         
Sponsors and Collaborators
University of Oklahoma
Investigators
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Principal Investigator: Elizabeth Hile, PhD University of Oklahoma
More Information
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Publications:

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Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT04959929    
Other Study ID Numbers: 12621
First Posted: July 13, 2021    Key Record Dates
Last Update Posted: March 6, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The de-identified data might be shared with permission from the funder and PI per request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: After study completion and publication of primary outcomes
Access Criteria: Only de-identified data will be shared with permission from the funder and PI per request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of Oklahoma:
focal vibration
wearable
in-home rehabilitation
 chemotherapy-induced peripheral neuropathy
CIPN
lower extremity
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases