Wearable Focal Vibration for Chemotherapy-Induced Peripheral Neuropathy

University of Oklahoma13 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chemotherapy-induced Peripheral Neuropathy

Interventions

Focal vibration therapyDEVICE

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Stephenson Cancer Center, OU Health

Oklahoma City, Oklahoma, United States

Outcomes

Primary Outcomes

Feasibility of Enrollment

Percent of interested individuals who enrolled.

Time frame: Baseline

Adherence to Myovolt Focal Vibration

Number of completed sessions the intervention was worn, as a percentage of the number of sessions prescribed.

Time frame: After 6-week intervention

Secondary Outcomes

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.

Time frame: Change from Baseline after 6-week Intervention

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.

Time frame: 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). Sensory and motor severity are rated separately.

Time frame: 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. Scores on a 9-point ordinal scale centered around 0 (Unchanged) ranged from -4 (very much worse) to 0 (unchanged) to +4 (very much better).

Data from ClinicalTrials.gov

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