Evaluation of the Efficacy of Acupuncture in Chemotherapy Induced Peripheral Neuropathy

Study Overview
=================
Brief Summary
-----------------
Peripheral neuropathy is currently the second most common side effect after chemotherapy, second only to the side effects of blood toxicity. A variety of chemotherapy drugs may induce peripheral neurotoxicity, and cause by the cumulative dose of chemotherapy drugs. Symptoms include sensory parasthesia, feeling dull or numbness, glove-like feeling distributed in the palm. The currently most effective way is to interrupt the treatment or adjust the dose of chemotherapeutic drugs, but it is easy to make patients discontinue chemotherapy. The purpose of this study is to explore the impact of acupuncture on neurological symptoms and quality of life. Three kinds of questionnairs will be used:(1) Brief pain inventory- short form to assess the extent of pain, and the impact of daily life. (2) FACT/GOG-NTX-13 (Version 4) to assess changes in neurological symptoms; (3) WHOQOL-BREF to assess changes in the quality of life of patients. The course of treatment was evaluated for nine weeks. Changes in neurological function and quality of life will be evaluated before treatment, the third week of treatment, the sixth week of treatment, till the ninth week. The aim of this study is to confirm that acupuncture can improve peripheral neuropathy after chemotherapy, in order to enhance breast cancer patients' quality of life, and provide the new opportunity for integrative therapy between Chinese and Western medicine. Keywords：acupuncture , chemotherapy-induced peripheral neuropathy

Official Title
-----------------
Evaluation the Efficacy of Acupuncture in Chemotherapy Induced Peripheral Neuropathy

Conditions
-----------------
Breast Cancer, Chemotherapy-induced Peripheral Neuropathy, Randomized Controlled Trial

Intervention / Treatment
-----------------
* Procedure: acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: more than 20 yeas old Female TypeI-IV breast cancer patients complete chemotherapy chemotherapeutic agents include taxanes、platinum compounds ect ECOG<3 NCI common terminology criteria for adverse events,v4.0: more than grade1 。 Exclusion Criteria: average life expectancy<3months diabetic neuropathy inflammatory neuropathy metabolic neuropathy severe blood coagulopathy or bleeding tendency unstable heart disease neuro-muscular disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| acupuncture group<br>acupuncture with de-chi sensation | Procedure: acupuncture<br>* manually manipulate acupuncture at CV6 and three acupoints on each arms and legs<br>|
| sham acupuncture group<br>skin-deep acupuncture without de-chi sensation | Procedure: acupuncture<br>* manually manipulate acupuncture at CV6 and three acupoints on each arms and legs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FACT/GOG-NTX-13 (Version 4) | Prorated subscale score = [Sum of item scores] x [N of items in subscale]÷ [N of items answered] For all FACIT scales and symptom indices, the higher the score the better the QOL. | 4 times in 9 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chemotherapy-induced peripheral neuropathy, acupuncture