Evaluation of the Efficacy of Acupuncture in Chemotherapy Induced Peripheral Neuropathy

Breast Cancer Clinical Trial

Official title:

Evaluation the Efficacy of Acupuncture in Chemotherapy Induced Peripheral Neuropathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03626220
• Other study ID #: CMUH106-REC2-117
• Status: Recruiting
• Start date: June 27, 2018
• Est. completion date: October 10, 2020

Study information

• Verified date: August 2019
• Source: China Medical University Hospital
• Contact: Chien-Chen Huang(Attending physician), master
• Phone: (06)355-3111
• Email: chenchinh2013[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 10, 2020
• Est. primary completion date: October 10, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Chemotherapy-induced Peripheral Neuropathy
• Peripheral Nervous System Diseases
• Randomized Controlled Trial

Intervention

Procedure:
• acupuncture
manually manipulate acupuncture at CV6 and three acupoints on each arms and legs

Locations

Country	Name	City	State
Taiwan	An Nan Hospital,China Medical University	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Greenlee H, Crew KD, Capodice J, Awad D, Buono D, Shi Z, Jeffres A, Wyse S, Whitman W, Trivedi MS, Kalinsky K, Hershman DL. Randomized sham-controlled pilot trial of weekly electro-acupuncture for the prevention of taxane-induced peripheral neuropathy in — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   pubmed