Wearable Focal Vibration for Chemotherapy-Induced Peripheral Neuropathy
- Conditions
- Chemotherapy-induced Peripheral Neuropathy
- Interventions
- Device: Focal vibration therapy
- Registration Number
- NCT04959929
- Lead Sponsor
- University of Oklahoma
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 15
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Focal vibration therapy 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.
- Primary Outcome Measures
Name Time Method Adherence to Myovolt focal vibration 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.
Feasibility of enrollment Baseline Percent of interested individuals who enrolled.
- Secondary Outcome Measures
Name Time Method Global Rating of Change (GROC) scale 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).
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-12 (FACT-GOG/NTX-12) Symptom Inventory 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.
Long-term retention 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.
Neuropathy Total Symptom Score-6 (NTSS-6) 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) 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.
Manual Muscle Testing (MMT) of Toes 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 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.
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-12 (FACT-GOG/NTX-12) Physical Well-Being Subscale 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 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.
Vibration Perception Threshold using Biothesiometer 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.
Trial Locations
- Locations (1)
Stephenson Cancer Center, OU Health
🇺🇸Oklahoma City, Oklahoma, United States