Acupuncture on Chemotherapy-induced Peripheral Neuropathy

January 17, 2025 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 paresthesia, feeling dullness 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 questionnaires will be used:(1) Brief pain inventory- short form to assess the extent of pain, and the impact of daily life. (2) the Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group- Neurotoxicity(FACT/GOG-NTX)-13 (Version 4) to assess changes in neurological symptoms; (3) World Health Organization Quality of Life Scale-(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

Completed

Conditions

Intervention / Treatment

Detailed Description

(I) Background of the research A variety of neurotoxic chemotherapeutic agents, including platinums (e.g. cisplatin, carboplatin, and oxaliplatin), taxanes (e.g. paclitaxel and docetaxel), and vinca alkaloids (e.g. vincristine and vinblastine), thalidomide and bortezomib, may induce peripheral neuropathy. Generally speaking, sensory nerve dysfunction is more common than motor involvement. It causes hands and feet to feel tingling, dullness or numbness symmetrically, which will be a glove-like ("glove-and-stocking type") sensation distributed in palms and soles. Patient's touch, vibration, and proprioception senses may be impaired under clinical examinations.

chemotherapy-induced peripheral neuropathy(CIPN) relates to the cumulative doses of chemotherapeutic agents. Sometimes, when chemotherapy is stopped, neuropathy symptoms may continue or worsen, which is called a "costing phenomenon". Nerve damaging usually starts from ends of the extremities, while individual doses were accumulated, it gradually extends to proximal joints or ganglions. CIPN is currently the second most common side, next to hematotoxicity. Within thirty days after chemotherapy, 68.1% of patients may develop CIPN, most of which can be relieved or improved, but there are still 30-83% symptoms persist over 6 months.

At present, the most effective way to treat CIPN is to stop the treatment protocol or adjust doses of chemotherapy; however, it affects the effect of chemotherapy in degrading tumor growth. Plenty of pharmacological or non-pharmacological treatments are still under investigation, such as antioxidant medication (e.g. Acetyl-L-carnitine, glutamine, vit B12, fish oil, etc.), anxiolytics (e.g. venlafaxine), neuroprotective agents (e.g. infusion of calcium ions, magnesium ions), food supplements, acupuncture, light stimulation, etc. Acupuncture with the advantages of clinically effective, easy-practice and relatively safe, few studies revealed its effect on CIPN, however, there is still a lack of large clinical trials to evaluate its effectiveness.

(ii) Purpose of the research To investigate the efficacy of acupuncture on peripheral neuropathy after chemotherapy administration in patients with breast cancer.

(iii) Importance of the research Current studies revealed that acupuncture might be effective on CIPN, however, insufficient number of participants or lack of control groups limit the quality of clinical studies. Therefore, the aim of our study to conduct a randomized controlled clinical trial to evaluate the efficacy of acupuncture on peripheral neuropathy caused by chemotherapy.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Taiwan
      • Tainan, Taiwan, 709
        • An Nan Hospital, China Medical University

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

Study Population

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

Description

The inclusion criteria will be: female more than 20 years of age; breast cancer with early stage at I-III; had completed chemotherapy; the neurotoxic chemotherapeutic agents included taxanes, platinums, or others; less than grade three in the Eastern Cooperative Oncology Group (ECOG) status; higher than grade one in National Cancer Institute-common terminology criteria for adverse events(NCI-CTCAE) scale.

The exclusion criteria will be: having less than three months in mean survival time, history of diabetic neuropathy before chemotherapy administration, history of other preexisting peripheral neuropathy, other inflammatory or metabolic arthritis, severe blood coagulation diseases or with latent bleeding tendency, unstable cardiovascular diseases, or other preexisting muscle-skeletal diseases.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The acupuncture group
Acupuncture treatment will be performed for 9 weeks. Acupuncture treatment will be performed for 9 weeks. The frequency of acupuncture will be twice a week for the first six weeks, and once a week for the following three weeks. 30 minutes needling at each treatment. Acupuncture points include Baihui(GV20), Qihai(CV6), Quchi(LI11), Hegu(LI4), Neiguan(P6), or Shenmen(HT7) for upper limbs. For plantar numbness, choose two acupoints to use in turn; use Weizhong(BL40), Sanyinjiao(SP6), or Zusanli(ST36) for lower limbs. If severe numbness occurred, Taixi(KI3) or Yongquan(K1) should be added for feet numbness. "De qi" sensation, such as soreness, numbness, pain, etc. will be achieved at each acupoints .
Other: acupuncture
More than five years of experienced certified acupuncturists performed all treatments using the study protocol and administered to all participants. The acupoints selection principle was based on the Bi syndrome(the impediment disease) recorded in the Huangdi's Internal Classic, the Traditional Chinese medicine literature. Disposable sterile stainless steel needles (CASOON, Wuxi Jiajian Medical Instrument Company, Limited., Jiangsu, China) with 0.3mm in diameter and 40mm in length, were inserted into the prespecified acupoints
Sham Comparator: The controlled group
Acupuncture with superficial needling 0.5 cun (estimated 1cm with deviation depends on the body size of each participants) away from the acupoints, which only superficially penetrated the skin without feeling of "De Qi" sensation.
Other: acupuncture
More than five years of experienced certified acupuncturists performed all treatments using the study protocol and administered to all participants. The acupoints selection principle was based on the Bi syndrome(the impediment disease) recorded in the Huangdi's Internal Classic, the Traditional Chinese medicine literature. Disposable sterile stainless steel needles (CASOON, Wuxi Jiajian Medical Instrument Company, Limited., Jiangsu, China) with 0.3mm in diameter and 40mm in length, were inserted into the prespecified acupoints

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Average Pain Severity in the Brief Pain Inventory-Short Form(BPI-SF)
Time Frame: We measured the average pain severity 4 times within 9 weeks [at baseline (before the first treatment) and week 3, week 6, and week 9 during the protocol].
The average pain severity was chosen as the primary assessment as neuropathy symptoms based on its ability to detect neuropathic pain in cancer patients, as well as its use to assess CIPN symptoms in other controlled clinical trials.The BPI-SF assesses pain when responding to the questionnaire (right now) and at its worst, least, and average pain severity in the last 24 h. The items range from 0 to 10 (0 = no pain; 10 = worst pain). The higher the pain severity scores, the worse the degree of pain experienced by the patient. We analyzed the data (1) within group analysis: compared the data at week 6 with baseline, and the data at week 9 with baseline from each group. (2) between group analysis: compared the acupuncture group and sham acupuncture group at week 6 and week 9. (3) the between group differences of the changes from week 6 to baseline and from week 9 to baseline.
We measured the average pain severity 4 times within 9 weeks [at baseline (before the first treatment) and week 3, week 6, and week 9 during the protocol].

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group- Neurotoxicity(FACT/GOG-NTX)-13
Time Frame: 4 times within 9 weeks: at baseline (before the first treatment) and week 3, week 6, and week 9 during the protocol

The 27-item FACT-G evaluated the quality of life of patients undergoing cancer therapy over the past 7 days. The question is rated on a five-point scale, from 0 to 4 (0= not at all; 4= very much) and summed ( total score range= 0-108). An increase in scores represents an improvement in the overall quality of life.The 13-item Ntx subscale measures the severity and impact of neurotoxicity symptoms over the past seven days. Items are rated on a five-point scale, scored from 0 to 4 and summed ( total score range= 0-52). Higher scores on the neurotoxicity scale indicate improvements in neurotoxic symptoms.

The 40-item FACT/GOG-Ntx total score represents the sum of the FACT-G and Ntx subscale (total score range=0-160).The FACT/GOG-Ntx trial outcome index (TOI) contained the scores of the PWB, FWB, and FACT/GOG-Ntx subscale (total score range= 0-104).We analyzed the data (1) within group analysis(2) between group analysis(3) the changes between group analysis
4 times within 9 weeks: at baseline (before the first treatment) and week 3, week 6, and week 9 during the protocol
World Health Organization Quality of Life Scale(WHOQOL)-BREF (Taiwan Version)
Time Frame: We measured 2 times within 9 weeks: before and after treatment
WHOQOL-BREF Taiwan version was validated to be a good clinical tool across five kinds of Taiwanese cancer survivors. There are a total 28 items by adding 2 additional items to account for Taiwanese cultural adaptations. Item scores range from 1 to 5 (1 =the worst condition; 5=the best condition), except for 3 items (Ph1, Ph2, and Ps6), which are reverse coded. Each domain in the scale can be translated into two ranges of domain scores (0-100 and 4-20), and we used 0-100 scale in this study. The Higher scores in each domain indicate the better quality of life for patients with cancers We analyzed the data (1) within group analysis: compared post-treatment with baseline. (2) between group analysis: compared the acupuncture group and sham acupuncture group at week 9. (3) the between group differences of the changes from post-treatment to baseline.
We measured 2 times within 9 weeks: before and after treatment
Touch Test Sensory Evaluator
Time Frame: 2 times within 9 weeks: before and after treatment
Measurements were performed using a set of 20 von Frey monofilaments(Semmes-Weinstein Von Frey Aesthesiometer, Stoelting Co. 620 Wheat Lane, Wood Dale, IL, U.S.A.), with evaluator size/target forces from 1.65/0.008 gto 6.65/300 g. Each monofilament was calibrated to a target force in grams (g) within a 5% standard deviation. Thresholds for categories of tactile perception were defined by the filament manufacturer as follows: normal ; diminished light touch; diminished protective sensation; loss of protective sensation; deep pressure sensation only . All tests were performed by an independent assessor who was unaware of the allocation of randomization. All the procedures followed the operation manual provided by the filament manufacturer. Measuring sites include: LHT(Left hand's middle fingertip);LHP(Left hand's palm);RHT(Right hand's middle fingertip);RHP(Right hand's palm);LFT(Left foot's big toe tip);LFP(Left foot's plantar);RFT(Right foot's big toe tip);RFP(Right foot's plantar)
2 times within 9 weeks: before and after treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Explore the Neuroprotective Mechanism of Acupuncture
Time Frame: 2 times within 9 weeks: before and after treatment
15 cc of blood samples will be drawn before and after 15 sessions of treatments from participants in both groups. The blood samples will be analyzed by enzyme-linked immunosorbent assay (ELISA) for tumor necrosis factor-alfa and interleukin- 6, interleukin-10 and brain-derived nuerotrophic factor to evaluate the differences in the inflammation state of peripheral nervous system within and between groups.
2 times within 9 weeks: before and after treatment

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, M.S., An Nan Hospital, China Medical University, Tainan, Taiwan, R.O.C.

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 (Actual)

October 10, 2020

Study Completion (Actual)

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)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 17, 2025

Last Verified

January 1, 2025

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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