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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Chemotherapy-induced Peripheral Neuropathy; CIPN
• Intervention / Treatment: Device: sham vagus nerve stimulation; Device: Vagus nerve stimulation

• Study Type: Interventional
• Enrollment (Anticipated): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • People's Hospital of Peking University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: stimulation group	Device: Vagus nerve stimulation; vagus nerve electrical stimulation through ear skin
PLACEBO_COMPARATOR: Sham stimulation group	Device: sham vagus nerve stimulation; sham vagus nerve electrical stimulation through ear skin

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 2, 2022
• Primary Completion (ANTICIPATED): August 1, 2022
• Study Completion (ANTICIPATED): November 1, 2022

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 26, 2022
• First Posted (ACTUAL): June 28, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 28, 2022
• Last Update Submitted That Met QC Criteria: June 26, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: 2022PHB107-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No