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Wearable Focal Vibration for Chemotherapy-Induced Peripheral Neuropathy

Primary Purpose

Chemotherapy-induced Peripheral Neuropathy

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Focal vibration therapy

About this trial

This is an interventional treatment trial for Chemotherapy-induced Peripheral Neuropathy focused on measuring focal vibration, wearable, in-home rehabilitation, chemotherapy-induced peripheral neuropathy, CIPN, lower extremity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Diagnosis of diabetes per patient report or based on medication inventory
Neuropathy (known or suspected) of any etiology other than chemotherapy (for example, due to diabetes, 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

Sites / Locations

Stephenson Cancer Center, OU HealthRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Focal vibration therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Feasibility of enrollment

Percent of interested individuals who enrolled.

Adherence to Myovolt focal vibration

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.

Secondary Outcome Measures

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.

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.

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) for both sensory and motor symptoms.

Global Rating of Change (GROC) scale

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).

Long-term retention

Number of enrolled individuals retained for long-term follow-up(after 6-week withdrawal period), and reasons for loss to follow-up, when available.

Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-12 (FACT-GOG/NTX-12) Physical Well-Being Subscale

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

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

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

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.

Vibration Perception Threshold using Biothesiometer

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.

Full Information

NCT ID

NCT04959929

First Posted

March 29, 2021

Last Updated

May 8, 2023

Sponsor

University of Oklahoma

1. Study Identification

Unique Protocol Identification Number

NCT04959929

Brief Title

Wearable Focal Vibration for Chemotherapy-Induced Peripheral Neuropathy

Official Title

Wearable Focal Vibration for Chemotherapy-Induced Peripheral Neuropathy

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 9, 2023 (Actual)

Primary Completion Date

September 30, 2023 (Anticipated)

Study Completion Date

September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Oklahoma

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chemotherapy-induced Peripheral Neuropathy

Keywords

focal vibration, wearable, in-home rehabilitation, chemotherapy-induced peripheral neuropathy, CIPN, lower extremity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Model Description

All participants will be assigned to a single group that will receive focal vibration therapy using Myovolt.

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Focal vibration therapy

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Focal vibration therapy

Other Intervention Name(s)

Myovolt

Intervention Description

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).

Primary Outcome Measure Information:

Title

Feasibility of enrollment

Description

Percent of interested individuals who enrolled.

Time Frame

Baseline

Title

Adherence to Myovolt focal vibration

Description

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.

Time Frame

After 6-week intervention

Secondary Outcome Measure Information:

Title

Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-12 (FACT-GOG/NTX-12) Symptom Inventory

Description

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

Title

Neuropathy Total Symptom Score-6 (NTSS-6)

Description

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

Title

Patient Neurotoxicity Questionnaire (PNQ)

Description

Time Frame

Change from Baseline after 6-week Intervention

Title

Global Rating of Change (GROC) scale

Description

Time Frame

After 6-week withdrawal period

Title

Long-term retention

Description

Number of enrolled individuals retained for long-term follow-up(after 6-week withdrawal period), and reasons for loss to follow-up, when available.

Time Frame

After 6-week withdrawal period

Title

Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-12 (FACT-GOG/NTX-12) Physical Well-Being Subscale

Description

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.

Time Frame

Change from Baseline after 6-week Intervention

Title

Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-12 (FACT-GOG/NTX-12) Functional Well-Being Subscale

Description

Time Frame

Change from Baseline after 6-week Intervention

Title

Manual Muscle Testing (MMT) of Toes

Description

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).

Time Frame

Change from Baseline after 6-week Intervention

Title

Toe Strength using a quantifiable toe measurement device

Description

Time Frame

Change from Baseline after 6-week Intervention

Title

Vibration Perception Threshold using Biothesiometer

Description

Time Frame

Change from Baseline after 6-week Intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Josiah Rippetoe, BS

Phone

4052711529

josiah-rippetoe@ouhsc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Abby Cha, BS

Phone

4052711529

abby-cha@ouhsc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elizabeth Hile, PhD

Organizational Affiliation

University of Oklahoma

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stephenson Cancer Center, OU Health

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Elizabeth Hile, PhD

Phone

405-271-1529

elizabeth-hile@ouhsc.edu

First Name & Middle Initial & Last Name & Degree

Kathleen Moore, PhD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The de-identified data might be shared with permission from the funder and PI per request.

IPD Sharing Time Frame

After study completion and publication of primary outcomes

IPD Sharing Access Criteria

Only de-identified data will be shared with permission from the funder and PI per request

Citations:

PubMed Identifier

28586243

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.

Results Reference

background

PubMed Identifier

28374323

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.

Results Reference

background

PubMed Identifier

29159795

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.

Results Reference

background

PubMed Identifier

24842220

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.

Results Reference

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Wearable Focal Vibration for Chemotherapy-Induced Peripheral Neuropathy

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