Electroacupuncture for chemotherapy-induced peripheral neuropathy: study protocol for a pilot multicentre randomized, patient-assessor-blinded, controlled trial

Abstract

BackgroundChemotherapy-induced peripheral neuropathy (CIPN) is the main dose-limiting side effect of neurotoxic chemotherapeutic agents. CIPN can lead not only to loss of physical function, difficulties in activities of daily living (ADLs), and decreased quality of life, but also to dose reduction, delay or even cessation of treatment. Currently, there are few proven effective treatments for CIPN. This randomized controlled clinical trial is designed to evaluate the effects and safety of electroacupuncture (EA) for patients with CIPN.Methods/designThis is a multicenter, two-armed, parallel-design, patient-assessor-blinded, randomized, sham-controlled clinical trial. Forty eligible patients with CIPN will be randomized in a ratio of 1:1 to the EA or sham EA arms. During the treatment phase, patients will undergo eight sessions of verum EA or sham EA twice weekly for four weeks, and then will be followed-up for eight weeks. Electrical stimulation in the EA group will consist of a mixed frequency of 2/120 Hz and 80% of bearable intensity. Sham EA will be applied to non-acupoints, with shallow needle insertion and no current. All outcomes and analyses of results will be assessed by researchers blinded to treatment allocation. The effects of EA on CIPN will be evaluated according to both subjective and objective outcome measures. The primary outcome measure will be the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire to assess CIPN (QLQ-CIPN20). The secondary outcome measures will be the results on the numerical rating scale, the Semmes-Weinstein monofilament test, the nerve conduction study, and the EORTC QLQ-C30, as well as the patient’s global impression of change and adverse events. Safety will be assessed at each visit.DiscussionThe results of this on-going study will provide clinical evidence for the effects and safety of EA for CIPN compared with sham EA.Trial registrationClinical Research Information Service: KCT0000506

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“…Acupuncture may also be effective, but a current lack of RCTs with positive results exists for this endpoint. An ongoing pilot study by Kim et al [78] will be the first multicenter randomized patient-assessor–blinded trial to evaluate electroacupuncture versus sham acupuncture for CIPN using EORTC-QLQCIPN20.…”

A Pilot Randomized Placebo Controlled Trial of Electroacupuncture for Women with Pure Stress Urinary Incontinence

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Low-level laser therapy alleviates mechanical and cold allodynia induced by oxaliplatin administration in rats

“…Moreover, as research continues into the role of pharmacological agents for treatment and/or prevention of oxaliplatin-induced peripheral neuropathy; interest in nonpharmacological treatment options is increasing. Studies have been lacking on non-pharmacological therapy for the treatment of oxaliplatin-peripheral neuropathy, although some clinical studies have been performed on acupuncture for the treatment of chemotherapy-induced peripheral neuropathy [39][40][41][42]. These studies reported improvements following acupuncture in the Visual Analog System (VAS) pain scale, gait, and nerve conduction tests, and reduced use of pain medication.…”