Acupuncture on Chemotherapy-induced Peripheral Neuropathy

NCT03626220 | Completed Results

• 1 other identifier: CMUH106-REC2-117
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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

Conditions

Randomized Controlled Trial; Breast Cancer; Chemotherapy-induced Peripheral Neuropathy; Acupuncture

Keywords

acupuncture; chemotherapy-induced peripheral neuropathy

Outcome Measures

Primary Outcomes (1)

• The Average Pain Severity in the Brief Pain Inventory-Short Form(BPI-SF)

  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 Outcomes (3)

• Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group- Neurotoxicity(FACT/GOG-NTX)-13

  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)

  We measured 2 times within 9 weeks: before and after treatment

• Touch Test Sensory Evaluator

  2 times within 9 weeks: before and after treatment

Other Outcomes (1)

• Explore the Neuroprotective Mechanism of Acupuncture

  2 times within 9 weeks: before and after treatment

Study Arms (2)

The acupuncture group

EXPERIMENTAL

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

The controlled group

SHAM COMPARATOR

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

Interventions

acupuncture OTHER

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

The acupuncture group; The controlled group

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

An Nan Hospital, China Medical University

Tainan, 709, Taiwan

Location

Related Publications (4)

• Franconi G, Manni L, Schroder S, Marchetti P, Robinson N. A systematic review of experimental and clinical acupuncture in chemotherapy-induced peripheral neuropathy. Evid Based Complement Alternat Med. 2013;2013:516916. doi: 10.1155/2013/516916. Epub 2013 Jul 24.

  PMID: 23983788 BACKGROUND

• Park SB, Goldstein D, Krishnan AV, Lin CS, Friedlander ML, Cassidy J, Koltzenburg M, Kiernan MC. Chemotherapy-induced peripheral neurotoxicity: a critical analysis. CA Cancer J Clin. 2013 Nov-Dec;63(6):419-37. doi: 10.3322/caac.21204.

  PMID: 24590861 BACKGROUND

• 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 RESULT

• Wong R, Major P, Sagar S. Phase 2 Study of Acupuncture-Like Transcutaneous Nerve Stimulation for Chemotherapy-Induced Peripheral Neuropathy. Integr Cancer Ther. 2016 Jun;15(2):153-64. doi: 10.1177/1534735415627926. Epub 2016 Apr 29.

  PMID: 27130723 RESULT

Related Links

• pubmed
• pubmed
• pubmed
• pubmed

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Results Point of Contact

• Title: Dr. Chien-Chen Huang
• Organization: An Nan Hospital, China Medical University, Tainan, Taiwan

chenchinh2013@gmail.com

886-6-3553111

Study Officials

• Chien-Chen Huang, M.S.

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Model Details: 1. The acupuncture group: 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 . 2. 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.

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: August 10, 2018
• Study Start: June 27, 2018
• Primary Completion: October 10, 2020
• Study Completion: October 10, 2020
• Last Updated: January 20, 2025
• Results First Posted: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)