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

NCT ID: NCT05434403

Last Updated: 2022-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-02

Study Completion Date

2022-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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CIPN Chemotherapy-induced Peripheral Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Sham stimulation group

Group Type PLACEBO_COMPARATOR

sham vagus nerve stimulation

Intervention Type DEVICE

sham vagus nerve electrical stimulation through ear skin

stimulation group

Group Type EXPERIMENTAL

Vagus nerve stimulation

Intervention Type DEVICE

vagus nerve electrical stimulation through ear skin

Interventions

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Vagus nerve stimulation

vagus nerve electrical stimulation through ear skin

Intervention Type DEVICE

sham vagus nerve stimulation

sham vagus nerve electrical stimulation through ear skin

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yi Feng, MD

director of department of Anesthesiology and Pain medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yi Feng, MD

Role: STUDY_CHAIR

Peking University People's Hospital

Locations

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People's Hospital of Peking University

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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2022PHB107-001

Identifier Type: -

Identifier Source: org_study_id

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