Chemotherapy-induced Peripheral Neuropathy
Conditions
Keywords
focal vibration, wearable, in-home rehabilitation, chemotherapy-induced peripheral neuropathy, CIPN, lower extremity
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.
Interventions
DEVICEFocal vibration therapy
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).
Sponsors
University of Oklahoma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All participants will be assigned to a single group that will receive focal vibration therapy using Myovolt.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Enrollment | Baseline | Percent of interested individuals who enrolled. |
| Adherence to Myovolt Focal Vibration | After 6-week intervention | Number of completed sessions the intervention was worn, as a percentage of the number of sessions prescribed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). Sensory and motor severity are rated separately. |
| Global Rating of Change (GROC) Scale | After 6-week intervention | 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). |
| 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. |
| Manual Muscle Testing (MMT) of Toes | Change from Baseline after 6-week Intervention | MMT assesses muscle strength by an assessor applying pressure against the hallux as the participant lifts and holds 1st metatarsophalangeal extension. Strength is rated from 0 (weakest) to 5 (strongest). Change of 1 grade from the baseline values is categorized as improvement or decline. |
| Change in Toe Strength Using a Proprietary Quantifiable Toe Measurement Device, Quantification of Hallux Extension Strength or QuHalEx(TM), U.S. Patent 11402284 Issued to the University of Oklahoma on 08/02/2022, and Provisional Patent 63/627,850. | Change from Baseline after 6-week Intervention | QuHalEx(TM) measures toe strength by reading force measurements (higher is stronger) when participants sit with foot strapped on a portable base of a proprietary University of Oklahoma QuHalEx(TM) load-cell prototype device (U.S. Patent 11402284 issued to the University of Oklahoma on 08/02/2022, and provisional patent 63/627,850). With the great toe inserted into a cap, the participant pulls up and holds isometrically for a few seconds. The peak force is the highest value recorded over the hold time. We report the change in peak force from baseline to the 6-week visit. |
| Vibration Perception Threshold Using Biothesiometer | Change from Baseline after 6-week Intervention | Vibratory threshold is measured by a non-invasive vibrating probe (biothesiometer) placed on the skin and increased from 0 Hz until the amplitude when the participant first reports detection (eyes closed) or the maximum amplitude available on the biothesiometer scale (50 Volts). Higher indicates worse sensation. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORElizabeth Hile, PhD
University of Oklahoma
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age, Continuous | 55.5 years STANDARD_DEVIATION 9.6 |
| BMI | 29.2 kg/sq m STANDARD_DEVIATION 5.7 |
| Cancer Type breast | 5 Participants |
| Cancer Type colorectal | 2 Participants |
| Cancer Type gynecological | 3 Participants |
| Cancer Type hematological | 2 Participants |
| Cancer Type testicular | 1 Participants |
| CIPN Persistence (yrs) | 4.2 years STANDARD_DEVIATION 3.4 |
| Diabetes diabetes | 4 Participants |
| Diabetes no diabetes | 9 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 13 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 7 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
None listed