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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Focal vibration therapy | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Focal vibration therapy | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of enrollment | Percent of interested individuals who enrolled. | Baseline |
| Adherence to Myovolt focal vibration | 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. | After 6-week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-12 (FACT-GOG/NTX-12) Symptom Inventory | 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. | Change from Baseline after 6-week Intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Hile, PhD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stephenson Cancer Center, OU Health | Oklahoma City | Oklahoma | 73104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28586243 | Background | 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. | |
| 28374323 | Background |
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The de-identified data might be shared with permission from the funder and PI per request.
After study completion and publication of primary outcomes
Only de-identified data will be shared with permission from the funder and PI per request
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 20, 2026 | Feb 5, 2026 | 10 | ||
| Mar 3, 2026 |
All participants will be assigned to a single group that will receive focal vibration therapy using Myovolt.
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| Neuropathy Total Symptom Score-6 (NTSS-6) | 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. | Change from Baseline after 6-week Intervention |
| Patient Neurotoxicity Questionnaire (PNQ) | 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. | Change from Baseline after 6-week Intervention |
| Global Rating of Change (GROC) scale | 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). | After 6-week withdrawal period |
| Long-term retention | Number of enrolled individuals retained for long-term follow-up(after 6-week withdrawal period), and reasons for loss to follow-up, when available. | After 6-week withdrawal period |
| Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-12 (FACT-GOG/NTX-12) Physical Well-Being Subscale | 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. | Change from Baseline after 6-week Intervention |
| Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-12 (FACT-GOG/NTX-12) Functional Well-Being Subscale | 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. | Change from Baseline after 6-week Intervention |
| Manual Muscle Testing (MMT) of Toes | 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). | Change from Baseline after 6-week Intervention |
| Toe Strength using a quantifiable toe measurement device | 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. | Change from Baseline after 6-week Intervention |
| Vibration Perception Threshold using Biothesiometer | 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. | Change from Baseline after 6-week Intervention |
| 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. |
| 29159795 | Background | 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. |
| 24842220 | Background | 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. |
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