期刊论文详细信息
Trials
Electroacupuncture for chemotherapy-induced peripheral neuropathy: study protocol for a pilot multicentre randomized, patient-assessor-blinded, controlled trial
Sun-Mi Choi1  Mi-Suk Shin1  Hyo-Ju Park1  Ae-Ran Kim1  Min-Hee Lee1  So-Young Jung1  Seunghoon Lee4  Sanghun Lee3  Byung-Kwan Seo4  Eun-Jung Kim2  Joo-Hee Kim4 
[1] Acupuncture, Moxibustion & Meridian Research Group, Medical Research Division, Korea Institute of Oriental Medicine, Daejeon, South Korea;College of Korean Medicine, Dongguk University, Gyeongju, South Korea;Department of medical consilence, Graduate school, Dankook University, Gyeonggi-do, South Korea;Department of Acupuncture & Moxibustion, College of Korean Medicine, Kyung Hee University, Seoul, South Korea
关键词: Clinical research protocol;    Safety;    Effect;    Electroacupuncture;    Chemotherapy-induced peripheral neuropathy;   
Others  :  1093241
DOI  :  10.1186/1745-6215-14-254
 received in 2013-03-21, accepted in 2013-08-07,  发布年份 2013
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【 摘 要 】

Background

Chemotherapy-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/design

This 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.

Discussion

The results of this on-going study will provide clinical evidence for the effects and safety of EA for CIPN compared with sham EA.

Trial registration

Clinical Research Information Service: KCT0000506

【 授权许可】

   
2013 Kim et al.; licensee BioMed Central Ltd.

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