Clinical trial NCT04959929: Wearable Focal Vibration for Chemotherapy-Induced Peripheral Neuropathy
Official title: Wearable Focal Vibration for Chemotherapy-Induced Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chemotherapy-induced Peripheral Neuropathy
Keywords: focal vibration
wearable
in-home rehabilitation
chemotherapy-induced peripheral neuropathy
CIPN
lower extremity
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2021-07-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will be assigned to a single group that will receive focal vibration therapy using Myovolt.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Feasibility of enrollment
timeFrame: Baseline
measure: Adherence to Myovolt focal vibration
timeFrame: After 6-week intervention
Secondary outcomes:
measure: Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-12 (FACT-GOG/NTX-12) Symptom Inventory
timeFrame: Change from Baseline after 6-week Intervention
measure: Neuropathy Total Symptom Score-6 (NTSS-6)
timeFrame: Change from Baseline after 6-week Intervention
measure: Patient Neurotoxicity Questionnaire (PNQ)
timeFrame: Change from Baseline after 6-week Intervention
measure: Global Rating of Change (GROC) scale
timeFrame: After 6-week withdrawal period
measure: Long-term retention
timeFrame: After 6-week withdrawal period
measure: Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-12 (FACT-GOG/NTX-12) Physical Well-Being Subscale
timeFrame: Change from Baseline after 6-week Intervention
measure: Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-12 (FACT-GOG/NTX-12) Functional Well-Being Subscale
timeFrame: Change from Baseline after 6-week Intervention
measure: Manual Muscle Testing (MMT) of Toes
timeFrame: Change from Baseline after 6-week Intervention
measure: Toe Strength using a quantifiable toe measurement device
timeFrame: Change from Baseline after 6-week Intervention
measure: Vibration Perception Threshold using Biothesiometer
timeFrame: Change from Baseline after 6-week Intervention
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center, OU Health
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Elizabeth Hile, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.