Wearable Focal Vibration for Chemotherapy-Induced Peripheral Neuropathy

Completed · Not applicable

Conditions studied: Chemotherapy-induced Peripheral Neuropathy

In brief

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.

Key facts

Study ID

NCT04959929

Run by

University of Oklahoma

People needed

13

Starts

2023-02-09

Expected to finish

2025-07-22

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stephenson Cancer Center, OU Health — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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