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

Not Applicable

• Conditions: Chemotherapy-induced Peripheral Neuropathy; CIPN
• Interventions: Device: sham vagus nerve stimulation; Device: Vagus nerve stimulation

• Registration Number: NCT05434403
• Lead Sponsor: Peking University People's Hospital

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2022-06
• Study Start: 2022-06-02
• Study First Submitted: 2022-06-08
• Study First Submitted QC: 2022-06-26
• Last Update Submitted: 2022-06-26
• Study First Posted: 2022-06-28
• Last Update Posted: 2022-06-28
• Primary Completion: 2022-08-01
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham stimulation group	sham vagus nerve stimulation	-
stimulation group	Vagus nerve stimulation	-

Primary Outcome Measures

Name	Time	Method
NRS(numerical rating scale)	Day90	0-10，0 =no pain, 10 = the most severe pain.

Secondary Outcome Measures

Name	Time	Method
QST( Quantitative Sensory Testing)	Day1,Day14	left finger, thermal thretshold,thermal pain threshold,cold threshold,cold pain threshold,
SF-12，Short From health survey -12	Day1,Day8,Day14,Day30,Day60,Day90	Calculate the Physical Component Summary (PCS) and; Mental Component Summary (MCS).The higher the score, the worse the quality of life
NCI-CTC v4.0 neurotoxicity classification	Day1,Day3,Day5,Day8,Day14,Day30,Day60,Day90	Assess the degree of motor neurotoxicity and sensory neurotoxicity
IL-2，IL-4，IL-6，IL-10，IFN-γ，TNF-α	Day1,Day14	Hematological examination to test the concentration of IL-2，IL-4，IL-6，IL-10，IFN-γ，TNF-α
Athens insomnia scale	Day1,Day8,Day14,Day30,Day60,Day90	\<4 No sleep disorder,4-6=Suspicious insomnia,\>6=Insomnia

Trial Locations

Locations (1)

People's Hospital of Peking University; 🇨🇳 Beijing, Beijing, China