Chemotherapy-induced Peripheral Neuropathy, CIPN
Conditions
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.
Interventions
DEVICEVagus nerve stimulation
vagus nerve electrical stimulation through ear skin
sham vagus nerve electrical stimulation through ear skin
Sponsors
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NRS(numerical rating scale) | Day0 | 0-10，0 =no pain, 10 = the most severe pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NCI-CTC v4.0 neurotoxicity classification | Day1,Day3,Day5,Day8,Day14,Day30,Day60,Day90 | Assess the degree of motor neurotoxicity and sensory neurotoxicity |
| QST( Quantitative Sensory Testing) | Day1,Day14 | left finger, thermal thretshold,thermal pain threshold,cold threshold,cold pain threshold, |
| 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 |
| 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 |
Countries
China
Outcome results
None listed