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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham stimulation group | Placebo Comparator |
| |
| stimulation group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vagus nerve stimulation | Device | vagus nerve electrical stimulation through ear skin |
| |
| 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 |
| 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, |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yi Feng, MD | Peking University People's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| People's Hospital of Peking University | Beijing | Beijing Municipality | 100044 | China |
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| ID | Term |
|---|---|
| D055536 | Vagus Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
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| sham vagus nerve stimulation |
| Device |
sham vagus nerve electrical stimulation through ear skin |
|
| 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 |