Wearable Focal Vibration for Chemotherapy-Induced Peripheral Neuropathy

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

Tracking Information

• First Submitted Date: March 29, 2021
• First Posted Date: July 13, 2021
• Last Update Posted Date: March 6, 2024
• Actual Study Start Date: February 9, 2023
• Estimated Primary Completion Date: September 30, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 17, 2022)

• Feasibility of enrollment [ Time Frame: Baseline ]
  Percent of interested individuals who enrolled.
• 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.

Original Primary Outcome Measures (submitted: July 12, 2021)

• Changes in CIPN symptoms and functional impairments as measured by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT-GOG/Ntx) [ Time Frame: Change from Baseline FACT-GOG/Ntx scores every 3 weeks for up to 12 weeks ]
  The FACT-GOG/Ntx is a composite measure of CIPN symptoms and functional impairments scored from 0 to 152 where a higher score indicates worse neuropathy symptoms
• Changes in neuropathic symptoms as measured by the Neuropathy Total Symptom Score-6 (NTSS-6) [ Time Frame: Changes from Baseline NTSS-6 scores every 3 weeks for up to 12 weeks ]
  The NTSS-6 rates neuropathic symptoms (severity and frequency) in 6-categories
• Changes in the extent of motor and sensory neuropathy as assessed by the Patient Neurotoxicity Questionnaire 3-item (PNQ) [ Time Frame: Changes from PNQ grades every 3 weeks for up to 12 weeks ]
  The PNQ grades the extent of sensory and motor neuropathy in cancer cohorts scored from grade A (no neuropathy) to grade E (severe neuropathy)
• Changes in patient-perspective neuropathy symptoms assessed by the Global Rating of Change Items (GROC) scale [ Time Frame: Changes from GROC scores every 3 weeks for up to 12 weeks ]
  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)

Current Secondary Outcome Measures (submitted: May 17, 2022)

• 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.
• 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.
• 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.
• 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).
• 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.
• 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.
• 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.
• 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).
• 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.
• 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.

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Wearable Focal Vibration for Chemotherapy-Induced Peripheral Neuropathy
• Official Title: Wearable Focal Vibration for Chemotherapy-Induced Peripheral Neuropathy
• 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.
• 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

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

• Condition: Chemotherapy-induced Peripheral Neuropathy

Intervention

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

Study Arms

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.

Intervention: Device: Focal vibration therapy

Publications *

• Winters-Stone KM, Horak F, Jacobs PG, Trubowitz P, Dieckmann NF, Stoyles S, Faithfull S. Falls, Functioning, and Disability Among Women With Persistent Symptoms of Chemotherapy-Induced Peripheral Neuropathy. J Clin Oncol. 2017 Aug 10;35(23):2604-2612. doi: 10.1200/JCO.2016.71.3552. Epub 2017 Jun 6.
• Monfort SM, Pan X, Patrick R, Ramaswamy B, Wesolowski R, Naughton MJ, Loprinzi CL, Chaudhari AMW, Lustberg MB. Gait, balance, and patient-reported outcomes during taxane-based chemotherapy in early-stage breast cancer patients. Breast Cancer Res Treat. 2017 Jul;164(1):69-77. doi: 10.1007/s10549-017-4230-8. Epub 2017 Apr 3.
• Miaskowski C, Mastick J, Paul SM, Abrams G, Cheung S, Sabes JH, Kober KM, Schumacher M, Conley YP, Topp K, Smoot B, Mausisa G, Mazor M, Wallhagen M, Levine JD. Impact of chemotherapy-induced neurotoxicities on adult cancer survivors' symptom burden and quality of life. J Cancer Surviv. 2018 Apr;12(2):234-245. doi: 10.1007/s11764-017-0662-8. Epub 2017 Nov 20.
• Murillo N, Valls-Sole J, Vidal J, Opisso E, Medina J, Kumru H. Focal vibration in neurorehabilitation. Eur J Phys Rehabil Med. 2014 Apr;50(2):231-42.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 12, 2021): 15
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2024
• Estimated Primary Completion Date: September 30, 2024 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Josiah Rippetoe, BS; 4052711529; josiah-rippetoe@ouhsc.edu

Contact: Abby Cha, BS; 4052711529; abby-cha@ouhsc.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04959929
• Other Study ID Numbers: 12621
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

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
• Supporting Materials: 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

• Current Responsible Party: University of Oklahoma
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Oklahoma
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Elizabeth Hile, PhD; University of Oklahoma

• PRS Account: University of Oklahoma
• Verification Date: March 2024