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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05434403
Other study ID # 2022PHB107-001
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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