Study Summary
This trial tests how vibration can reduce nerve pain in cancer patients.
Eligible Conditions
- Chemotherapy-induced Peripheral Neuropathy
Treatment Effectiveness
Effectiveness Progress
Study Objectives
6 Primary · 10 Secondary · Reporting Duration: After 6-week intervention
After 6-week intervention
Adherence to Myovolt focal vibration
After 6-week withdrawal period
Global Rating of Change (GROC) scale
Long-term retention
Baseline
Feasibility of enrollment
Week 12
Changes in CIPN symptoms and functional impairments as measured by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT-GOG/Ntx)
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
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-12 (FACT-GOG/NTX-12) Physical Well-Being Subscale
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-12 (FACT-GOG/NTX-12) Symptom Inventory
Manual Muscle Testing (MMT) of Toes
Neuropathy Total Symptom Score-6 (NTSS-6)
Patient Neurotoxicity Questionnaire (PNQ)
Toe Strength using a quantifiable toe measurement device
Vibration Perception Threshold using Biothesiometer
Week 12
Changes in neuropathic symptoms as measured by the Neuropathy Total Symptom Score-6 (NTSS-6)
Week 12
Changes in patient-perspective neuropathy symptoms assessed by the Global Rating of Change Items (GROC) scale
Week 12
Changes in the extent of motor and sensory neuropathy as assessed by the Patient Neurotoxicity Questionnaire 3-item (PNQ)
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Focal vibration therapy
1 of 1
Experimental Treatment
15 Total Participants · 1 Treatment Group
Primary Treatment: Focal vibration therapy · No Placebo Group · Phase 1
Focal vibration therapy
Device
Experimental Group · 1 Intervention: Focal vibration therapy · Intervention Types: DeviceTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: after 6-week intervention
Who is running the clinical trial?
University of OklahomaLead Sponsor
426 Previous Clinical Trials
98,237 Total Patients Enrolled
Hongwu Wang, PhDPrincipal InvestigatorUniversity of Oklahoma
2 Previous Clinical Trials
4 Total Patients Enrolled
Elizabeth Hile, PhDPrincipal InvestigatorUniversity of Oklahoma
Eligibility Criteria
Age 18+ · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:If you take pain medication, you must keep taking the same amount as you did for the two weeks before the study. You cannot make big changes to your pain medication while participating in the study, and you must let the study team know if you do make any changes.
References
- Bento, Virgílio F., Vítor Tedim Cruz, David D. Ribeiro, and João P. Cunha. 2012. “The Vibratory Stimulus as a Neurorehabilitation Tool for Stroke Patients: Proof of Concept and Tolerability Test”. Neurorehabilitation. IOS Press. doi:10.3233/nre-2012-0757.
- Monfort, Scott M., Xueliang Pan, Robyn Patrick, Bhuvaneswari Ramaswamy, Robert Wesolowski, Michelle J. Naughton, Charles L. Loprinzi, Ajit M. W. Chaudhari, and Maryam B. Lustberg. 2017. “Gait, Balance, and Patient-reported Outcomes During Taxane-based Chemotherapy in Early-stage Breast Cancer Patients”. Breast Cancer Research and Treatment. Springer Science and Business Media LLC. doi:10.1007/s10549-017-4230-8.
- Winters-Stone, Kerri M., Fay Horak, Peter G. Jacobs, Phoebe Trubowitz, Nathan F. Dieckmann, Sydnee Stoyles, and Sara Faithfull. 2017. “Falls, Functioning, and Disability Among Women with Persistent Symptoms of Chemotherapy-induced Peripheral Neuropathy”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2016.71.3552.
- Miaskowski, Christine, Judy Mastick, Steven M. Paul, Gary Abrams, Steven Cheung, Jennifer Henderson Sabes, Kord M. Kober, et al.. 2017. “Impact of Chemotherapy-induced Neurotoxicities on Adult Cancer Survivors’ Symptom Burden and Quality of Life”. Journal of Cancer Survivorship. Springer Science and Business Media LLC. doi:10.1007/s11764-017-0662-8.
- Bento, Virgílio F., Vítor Tedim Cruz, David D. Ribeiro, and João P. Cunha. 2012. “The Vibratory Stimulus as a Neurorehabilitation Tool for Stroke Patients: Proof of Concept and Tolerability Test”. Neurorehabilitation. IOS Press. doi:10.3233/nre-2012-0757.
- 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.
- 2023. "Wearable Focal Vibration for Chemotherapy-Induced Peripheral Neuropathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04959929.