Transauricular Vagus Nerve Stimulation in the Treatment of Chemotherapy-induced Peripheral Neuropathy

Peking University

Status: Invitation-only

Conditions: Chemotherapy-induced Peripheral Neuropathy; CIPN

Treatments: Device: sham vagus nerve stimulation; Device: Vagus nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05434403

2022PHB107-001

Details and patient eligibility

About

Chemotherapy induced peripheral neuropathy is common in tumor patients receiving chemotherapy. Nowaday, CIPN is mainly treated with drugs, but the therapeutic effect is not satisfactory. Previous studies have found that inflammatory immune mechanism plays an important role in neuropathic pain. Vagus nerve stimulation can not only relieve pain by regulating the autonomic nervous system, but also participate in the immune response. Investigators hope that the treatment by vagus nerve electrical stimulation through ear skin can improve the pain and neurotoxicity scores of CIPN patient.If it is proved that vagus nerve stimulation can effectively treat CIPN, it will become a simple and safe non-drug treatment which has good application prospects.

Enrollment: 26 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient is currently receiving chemotherapy drugs with neurotoxicity
2. New or worsening numbness and / or pain in the hands and / or feet, and no other cause explains the above symptoms

Exclusion criteria

1. Patients with sinus bradycardia, long QT syndrome, sick sinus syndrome or other arrhythmias, mental diseases, cardiac pacemakers or other electrical stimulation devices after implantation.
2. Patients taking analgesics due to pain in other parts of the body.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 2 patient groups, including a placebo group

Sham stimulation group

Placebo Comparator group

Treatment:

Device: sham vagus nerve stimulation

stimulation group

Experimental group

Treatment:

Device: Vagus nerve stimulation