An interventional study of True acupuncture + standard anti chemotherapy-induced peripheral neuropathy treatment and Sham acupuncture +standard anti chemotherapy-induced peripheral neuropathy treatment in Chemotherapy-induced Peripheral Neuropathy (CIPN) and Cancer, sponsored by Zhongnan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-20.
Sponsored by Zhongnan Hospital · Not applicable, Interventional, and Treatment
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.
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.
1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.
This study's planned enrollment of 150 is above the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.
Browse Peripheral Nervous System Diseases studies →Zhongnan Hospital is the lead sponsor of 103 studies on the registry; 48 are open to participants now.
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Exclusion Criteria:
Procedure: True acupuncture + standard anti chemotherapy-induced peripheral neuropathy treatment
Procedure: Sham 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.
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.
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.
Time frame: From enrollment to week 6
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.
Time frame: baseline,week 3, week6
Plan to share: No
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