Evaluation of the Efficacy of Acupuncture in Chemotherapy Induced Peripheral Neuropathy

August 31, 2019 updated by: Chien-Chen Huang, China Medical University Hospital

Evaluation the Efficacy of Acupuncture in Chemotherapy Induced Peripheral Neuropathy

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chien-Chen Huang(Attending physician), master
  • Phone Number: 2231 (06)355-3111
  • Email: chenchinh2013@gmail.com

Study Locations

  • Taiwan
      • Tainan, Taiwan, 709
        • Recruiting
        • An Nan Hospital,China Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

breast cancer patients who complete whole courses of chemotherapy obtain peripheral neuropathy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
acupuncture group
acupuncture with de-chi sensation
Procedure: acupuncture
manually manipulate acupuncture at CV6 and three acupoints on each arms and legs
sham acupuncture group
skin-deep acupuncture without de-chi sensation
Procedure: acupuncture
manually manipulate acupuncture at CV6 and three acupoints on each arms and legs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FACT/GOG-NTX-13 (Version 4)
Time Frame: 4 times in 9 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Investigators

  • Principal Investigator: Chien-Chen Huang(Attending physician), master, Traditional Chinese medcine department, An-Nan Municiple Hospital, China Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2018

Primary Completion (Anticipated)

October 10, 2020

Study Completion (Anticipated)

October 10, 2020

Study Registration Dates

First Submitted

August 8, 2018

First Submitted That Met QC Criteria

August 8, 2018

First Posted (Actual)

August 10, 2018

Study Record Updates

Last Update Posted (Actual)

September 4, 2019

Last Update Submitted That Met QC Criteria

August 31, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH106-REC2-117

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Study Data/Documents

  1. Clinical Study Report

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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