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

Study Overview
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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.

Official Title
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Transauricular Vagus Nerve Stimulation in the Treatment of Chemotherapy-induced Peripheral Neuropathy: A Randomized Controlled Study

Conditions
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CIPN, Chemotherapy-induced Peripheral Neuropathy

Intervention / Treatment
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* Device: Vagus nerve stimulation
* Device: sham vagus nerve stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is currently receiving chemotherapy drugs with neurotoxicity New or worsening numbness and / or pain in the hands and / or feet, and no other cause explains the above symptoms Exclusion Criteria: Patients with sinus bradycardia, long QT syndrome, sick sinus syndrome or other arrhythmias, mental diseases, cardiac pacemakers or other electrical stimulation devices after implantation. Patients taking analgesics due to pain in other parts of the body.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Sham stimulation group<br> | Device: sham vagus nerve stimulation<br>* sham vagus nerve electrical stimulation through ear skin<br>|
| Experimental: stimulation group<br> | Device: Vagus nerve stimulation<br>* vagus nerve electrical stimulation through ear skin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS(numerical rating scale) | 0-10，0 =no pain, 10 = the most severe pain. | Day0 | 
| NRS(numerical rating scale) | 0-10，0 =no pain, 10 = the most severe pain. | Day3 | 
| NRS(numerical rating scale) | 0-10，0 =no pain, 10 = the most severe pain. | Day5 | 
| NRS(numerical rating scale) | 0-10，0 =no pain, 10 = the most severe pain. | Day8 | 
| NRS(numerical rating scale) | 0-10，0 =no pain, 10 = the most severe pain. | Day14 | 
| NRS(numerical rating scale) | 0-10，0 =no pain, 10 = the most severe pain. | Day30 | 
| NRS(numerical rating scale) | 0-10，0 =no pain, 10 = the most severe pain. | Day60 | 
| NRS(numerical rating scale) | 0-10，0 =no pain, 10 = the most severe pain. | Day90 | 

Secondary Outcome Measures

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