Effect of Adding Electroacupuncture to Anti-cancer Therapy-induced Peripheral Neuropathy

Effect of Adding Electroacupuncture Combined With Standard Anti Chemotherapy-induced Peripheral Neuropathy Drugs to Anti-cancer Therapy-induced Peripheral Neuropathy: a Randomized Multicentered Clinical Trial.

This study is being done to evaluate the potential benefits of using electroacupuncture to reduce the severity of chemotherapy-induced peripheral neuropathy for patients with peripheral neuropathy after chemotherapy.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Chemotherapy-induced Peripheral Neuropathy (CIPN)
• Intervention / Treatment: Procedure: True acupuncture + standard anti chemotherapy-induced peripheral neuropathy treatment; Procedure: Sham acupuncture +standard anti chemotherapy-induced peripheral neuropathy treatment

Detailed Description

Chemotherapy-induced peripheral neuropathy (CIPN) refers to symptoms caused by chemotherapy drugs, such as numbness, tingling sensation, decreased sensation, hypersensitivity, or even limb dysfunction and muscle atrophy, which can be divided into five grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). The higher the grade, the more severe the symptoms. The incidence of chemotherapy-induced peripheral neuropathy (CIPN) reached 68.1% within the first month after treatment. About one-third of patients may develop chronic CIPN six months or more after chemotherapy, which significantly impairs the patients' quality of life. Electroacupuncture, as a nonpharmacologic therapy, is minimally invasive, with few side effects, and has demonstrated efficacy in various conditions including chemotherapy-induced nausea and vomiting. However, studies on its effectiveness against CIPN still yields inconsistent results.

This is a parallel-group, double-blinded (participants and statisticians), randomized controlled study that investigates the role of electroacupuncture compared with sham acupuncture for patients receiving chemotherapy. Both groups will receive the standard therapy for CIPN. On this basis, electroacupuncture or sham acupuncture will be randomly administered to the two groups. The investigators will explore the efficiency of electroacupuncture in reducing the severity of CIPN. Primary and secondary outcomes and adverse events will be evaluated.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haijun Yu; Phone Number: +86 67811727; Email: haijunyu@whu.edu.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Zhongnan Hospital of Wuhan University
      • Contact: Haiju Yu; Phone Number: 86-67811727; Email: haijunyu@whu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years of age or older, of any nationality.
• Patients diagnosed with malignant tumor.
• Eligible patients will report altered sensations and/or pain and/or other neurological symptoms, with a grade between 2-3 for chemotherapy-induced peripheral neuropathy on the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events-version 5.0 (NCI-CTCAE.v-5.0).
• Predicted life expectancy of ≥3 months.
• Intact skin without any breaches or purulent discharge.
• Written informed consent by the patient before enrolment Patients must be able to comply with the study protocol, which includes attending the treatment sessions on time and completing the study questionnaires in accordance with the study protocol.

Exclusion Criteria:

• History of pre-existing peripheral neuropathy before chemotherapy, including alcoholism, vitamin B deficiency, diabetes, HIV, congenital neuropathy, and toxic neuropathy.
• Patients with skin damage, pus or scar at the acupuncture stimulation area.
• Patients who are pregnant or breastfeeding.
• Significant mental conditions.
• Patients not fulfilling the inclusion criteria.
• Patients receiving other acupuncture treatments during the trial.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: True acupuncture + standard anti chemotherapy-induced peripheral neuropathy treatment	Procedure: True acupuncture + standard anti chemotherapy-induced peripheral neuropathy treatment; Participants will receive a total of 8 treatments over 6 weeks, with twice a week treatments for the first and the forth weeks and weekly treatment for the remaining weeks.The acupuncturists will insert needles into the acupoints and manipulate the needles until"de qi"sensation is achieved and reported by the participants. In the meantime, participants will receive the same standard anti-CIPN treatments.
Placebo Comparator: Sham acupuncture +standard anti chemotherapy-induced peripheral neuropathy treatment	Procedure: Sham acupuncture +standard anti chemotherapy-induced peripheral neuropathy treatment; The sham acupuncture comprised a core standardized prescription of minimally invasive, shallow needle insertion using thin and short needles at body locations not recognized as true acupuncture points and are deemed to not belong to traditional Chinese meridians and have no therapeutic value. Participants will receive minimal acupuncture treatment without electrical stimulation at the same time as the intervention group. Care was taken to avoid "de qi" sensation. In the meantime, participants will receive the same standard anti-CIPN treatments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference of the CIPN grade from baseline to week 6 after baseline	The primary outcome will be the proportion of patients whose CIPN grade improved after the completion of 8 acupuncture treatments sessions.	From enrollment to week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in FACT/NTX subscale baseline to 6 weeks	Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) is a 38-item self-reported questionnaire: the 27-item general assessment of Quality of Life scale (FACT-G),alongside its 11-item neurotoxicity-specific module. Considering the patient's compliance, the investigators only require the patient to complete the 11-item neurotoxicity-specific module.	baseline,week 3, week6

Collaborators and Investigators

• Sponsor: Zhongnan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2025
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): March 30, 2027

Study Registration Dates

• First Submitted: February 27, 2025
• First Submitted That Met QC Criteria: February 27, 2025
• First Posted (Actual): March 5, 2025

Study Record Updates

• Last Update Posted (Actual): April 20, 2025
• Last Update Submitted That Met QC Criteria: April 15, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Chemotherapy-induced peripheral neuropathy (CIPN); electroacupuncture treatment
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: ZNYYKL2025013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No