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
Highlights
Chemotherapy-induced peripheral neuropathy (CIPN) is the main dose-limiting side effect of neurotoxic chemotherapeutic agents
The results of this on-going study will provide clinical evidence for the effects and safety of EA for CIPN compared with sham EA
Chemotherapy-induced peripheral neuropathy (CIPN) is defined as damage to the peripheral nervous system induced by neurotoxic chemotherapeutic agents, including platinum compounds such as oxaliplatin and cisplatin, taxanes such as paclitaxel and docetaxel, and vinca alkaloids like vincristine [1,2]
Summary
Chemotherapy-induced peripheral neuropathy (CIPN) is the main dose-limiting side effect of neurotoxic chemotherapeutic agents. CIPN can lead to loss of physical function, difficulties in activities of daily living (ADLs), and decreased quality of life, and to dose reduction, delay or even cessation of treatment. CIPN is one of the major dose-limiting side effects of chemotherapy and can lead to loss of physical function, difficulties in activities of daily living (ADLs), and decreased quality of life (QOL), and to dose reduction or delay or even cessation of treatment [4,5]. Alternative dosing regimens and treatment modification schemes have been found to be effective in reducing the incidence and/or severity of CIPN [6,7] These strategies, can potentially affect tumor response and disease progression. No agent has proven effective in the treatment or mitigation of CIPN [8,9], underscoring the need for the development of novel treatments
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