Evaluation the Efficacy of Acupuncture in Chemotherapy Induced Peripheral Neuropathy

Evaluation of the Efficacy of Acupuncture in Chemotherapy Induced Peripheral Neuropathy



Sponsors


Source

China Medical University Hospital

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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

Overall Status

Recruiting

Start Date

2018-06-27

Completion Date

2019-10-10

Primary Completion Date

2019-10-10

Study Type

Observational

Primary Outcome

Measure

Time Frame

FACT/GOG-NTX-13 (Version 4)
4 times in 9 weeks

Number Of Groups

2

Enrollment

50

Conditions


Intervention

Intervention Type

Procedure

Intervention Name


Description

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

Arm Group Label

acupuncture group

sham acupuncture group



Eligibility

Study Pop

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

Sampling Method

Probability Sample

Criteria

Inclusion Criteria:

- more than 20 yeas old Female

- TypeI-III 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

Gender

Female

Minimum Age

20 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

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

Overall Contact

Last Name

Chien-Chen Huang(Attending physician), master

Phone

(06)355-3111

Phone Ext

2231

Email



Location

Facility

Status

Contact

An Nan Hospital,China Medical University
Tainan 709 Taiwan
Recruiting
Last Name: Tsai-Wang Chang(Professor), Doctor
Phone: +886-6-3553111
Email: [email protected]

Location Countries

Country

Taiwan


Verification Date

2018-08-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

China Medical University Hospital

Investigator Full Name

Chien-Chen Huang

Investigator Title

Principal Investigator


Keywords


Has Expanded Access

No

Condition Browse


Arm Group

Arm Group Label

acupuncture group

Description

acupuncture with de-chi sensation


Arm Group Label

sham acupuncture group

Description

skin-deep acupuncture without de-chi sensation



Results Reference

Citation

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 women with early stage breast cancer. Breast Cancer Res Treat. 2016 Apr;156(3):453-464. doi: 10.1007/s10549-016-3759-2. Epub 2016 Mar 25.

PMID

27013473


Firstreceived Results Date

N/A

Patient Data

Sharing Ipd

No


Study Docs

Study Doc

Doc Type

Clinical Study Report

Doc Url

https://www.ncbi.nlm.nih.gov/pubmed/27013473



Firstreceived Results Disposition Date

N/A

Study Design Info

Observational Model

Case-Control

Time Perspective

Prospective


Study First Submitted

August 8, 2018

Study First Submitted Qc

August 8, 2018

Study First Posted

August 10, 2018

Last Update Submitted

August 12, 2018

Last Update Submitted Qc

August 12, 2018

Last Update Posted

August 14, 2018


ClinicalTrials.gov processed this data on August 31, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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