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


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


BACKGROUND
Clinical Research Information Service: KCT0000506.
Acupuncture, Moxibustion & Meridian Research Group, Medical Research Division, Korea Institute of Oriental Medicine, Daejeon, South Korea.
Joo-Hee
JH
Kim
Eun-Jung
EJ
Kim
Byung-Kwan
BK
Seo
Sanghun
S
Lee
Seunghoon
S
Lee
So-Young
SY
Jung
Min-Hee
MH
Lee
Ae-Ran
AR
Kim
Hyo-Ju
HJ
Park
Mi-Suk
MS
Shin
Sun-Mi
SM
Choi
D000970:Antineoplastic Agents / Q000009:adverse effects*; D002985:Clinical Protocols; D015671:Electroacupuncture / Q000009:adverse effects; D006801:Humans; D009460:Neurologic Examination; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced / Q000175:diagnosis / Q000628:therapy*; D010865:Pilot Projects; D011237:Predictive Value of Tests; D011788:Quality of Life; D056910:Republic of Korea; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
D000970:Antineoplastic Agents