Clinical trial NCT06858709: Effect of Adding Electroacupuncture to Anti-cancer Therapy-induced Peripheral Neuropathy
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chemotherapy-induced Peripheral Neuropathy (CIPN)
Cancer
Keywords: Chemotherapy-induced peripheral neuropathy (CIPN)
electroacupuncture treatment
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Difference of the CIPN grade from baseline to week 6 after baseline
timeFrame: From enrollment to week 6
Secondary outcomes:
measure: Changes in FACT/NTX subscale baseline to 6 weeks
timeFrame: baseline,week 3, week6
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan hospital of Wuhan University
state: Hubei
Study officials:
References: