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

Chemotherapy-induced Peripheral Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05434403
• Other study ID #: 2022PHB107-001
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 2, 2022
• Est. completion date: November 1, 2022

Study information

• Verified date: June 2022
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 26
• Est. completion date: November 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chemotherapy-induced Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Device:
• Vagus nerve stimulation
vagus nerve electrical stimulation through ear skin
• sham vagus nerve stimulation
sham vagus nerve electrical stimulation through ear skin

Locations

Country	Name	City	State
China	People's Hospital of Peking University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NRS(numerical rating scale)	0-10,0 =no pain, 10 = the most severe pain.	Day0
Primary	NRS(numerical rating scale)	0-10,0 =no pain, 10 = the most severe pain.	Day3
Primary	NRS(numerical rating scale)	0-10,0 =no pain, 10 = the most severe pain.	Day5
Primary	NRS(numerical rating scale)	0-10,0 =no pain, 10 = the most severe pain.	Day8
Primary	NRS(numerical rating scale)	0-10,0 =no pain, 10 = the most severe pain.	Day14
Primary	NRS(numerical rating scale)	0-10,0 =no pain, 10 = the most severe pain.	Day30
Primary	NRS(numerical rating scale)	0-10,0 =no pain, 10 = the most severe pain.	Day60
Primary	NRS(numerical rating scale)	0-10,0 =no pain, 10 = the most severe pain.	Day90
Secondary	NCI-CTC v4.0 neurotoxicity classification	Assess the degree of motor neurotoxicity and sensory neurotoxicity	Day1,Day3,Day5,Day8,Day14,Day30,Day60,Day90
Secondary	QST( Quantitative Sensory Testing)	left finger, thermal thretshold,thermal pain threshold,cold threshold,cold pain threshold,	Day1,Day14
Secondary	IL-2,IL-4,IL-6,IL-10,IFN-?,TNF-a	Hematological examination to test the concentration of IL-2,IL-4,IL-6,IL-10,IFN-?,TNF-a	Day1,Day14
Secondary	Athens insomnia scale	<4 No sleep disorder,4-6=Suspicious insomnia,>6=Insomnia	Day1,Day8,Day14,Day30,Day60,Day90
Secondary	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