The Exploratory Study of Electroacupuncture in the Treatment of Peripheral Neuropathy Induced by Platinum Based Chemotherapy Drugs

Study Overview
=================
Brief Summary
-----------------
Through the research to confirm the effectiveness and safety of using electroacupuncture in the treatment of chemotherapy-induced peripheral neuropathy.

Official Title
-----------------
The Exploratory Study of Electroacupuncture in the Treatment of Peripheral Neuropathy Induced by Platinum Based Chemotherapy Drugs

Conditions
-----------------
Chemotherapy-induced Peripheral Neuropathy

Intervention / Treatment
-----------------
* Device: electroacupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The histopathological and / or cellular pathology results prove malignancy of the tumor and the patient has received chemotherapy treatment before. 15weeks after the completion of chemotherapy, the limbs are still feeling abnormal and the symptoms fulfill World Health Organization (WHO) grade 2 or more. zubrod - Eastern Cooperative Oncology Group-WHO (ZPS) grade 0-2, cardiac function, liver function and renal function are not significantly abnormal, the survival period of the patient is expected to be more than 6 months. Gender unrestricted, aged between 18 to 80 years old. Voluntary participation in the study, will to sign informed consent, willing to comply with randomized grouping, will to follow-up. Exclusion Criteria: Patients who suffer from peripheral neuropathy due to infection, radiotherapy, HIV, chronic alcoholism, hypothyroidism, diabetes, paraneoplastic syndrome or other diseases; or are suffering from nervous system diseases. Patients who are being treated with other drugs that may lead to neurotoxicity . Patients with blood coagulation disorder. Pregnancy and lactating women. Patients with infection, scarring or defects near the acupoint sites. Received intervention for the prevention and treatment of peripheral neuropathy 2 weeks before screening or has received traditional Chinese medicine (acupuncture, moxibustion, cupping, Chinese medicine therapy one month before.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electroacupuncture group<br> | Device: electroacupuncture<br>* Acupoint selection: Bilateral Hegu (LI4), Qu-chi (LI1) of upper limbs and bilateral Zusanli (ST36) ,Taichung (LR3)of lower limbs.<br>|
| No Intervention: control group<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy (QLQ-CIPN20) |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Assessment of Cancer Treatment - General scale（FACT-G） |  | 6 weeks |