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

Trials

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

【 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.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Pachman DR, Barton DL, Watson JC, Loprinzi CL: Chemotherapy-induced peripheral neuropathy: prevention and treatment. Clin Pharmacol Ther 2011, 90:377-387.
• [2]Ocean AJ, Vahdat LT: Chemotherapy-induced peripheral neuropathy: pathogenesis and emerging therapies. Support Care Canc 2004, 12:619-625.
• [3]Windebank AJ, Grisold W: Chemotherapy-induced neuropathy. J Peripher Nerv Syst 2008, 13:27-46.
• [4]Brittany MD: Chemotherapy-Induced Peripheral Neuropathy. NCI: Cancer Bulletin; 2010:7.
• [5]Wilkes G: Peripheral neuropathy related to chemotherapy. Semin Oncol Nurs 2007, 23:162-173.
• [6]Tournigand C, Cervantes A, Figer A, Lledo G, Flesch M, Buyse M, Mineur L, Carola E, Etienne PL, Rivera F, Chirivella I, Perez-Staub N, Louvet C, Andre T, Tabah-Fisch I, de Gramont A: OPTIMOX1: a randomized study of FOLFOX4 or FOLFOX7 with oxaliplatin in a Stop-and-Go fashion in advanced colorectal cancer - a GERCOR study. J Clin Oncol 2006, 24:394-400.
• [7]Richardson PG, Sonneveld P, Schuster MW, Stadtmauer EA, Facon T, Harousseau JL, Ben-Yehuda D, Lonial S, Goldschmidt H, Reece D, Blade J, Boccadoro M, Cavenagh JD, Boral AL, Esseltine DL, Wen PY, Amato AA, Anderson KC, San Miguel J: Reversibility of symptomatic peripheral neuropathy with bortezomib in the phase III APEX trial in relapsed multiple myeloma: impact of a dose-modification guideline. Br J Haematol 2009, 144:895-903.
• [8]Rao RD, Michalak JC, Sloan JA, Loprinzi CL, Soori GS, Nikcevich DA, Warner DO, Novotny P, Kutteh LA, Wong GY: Efficacy of gabapentin in the management of chemotherapy-induced peripheral neuropathy: a phase 3 randomized, double-blind, placebo-controlled, crossover trial (N00C3). Cancer 2007, 110:2110-2118.
• [9]Rao RD, Flynn PJ, Sloan JA, Wong GY, Novotny P, Johnson DB, Gross HM, Renno SI, Nashawaty M, Loprinzi CL: Efficacy of lamotrigine in the management of chemotherapy-induced peripheral neuropathy: a phase 3 randomized, double-blind, placebo-controlled trial, N01C3. Cancer 2008, 112:2802-2808.
• [10]Jin Z, Zhang BF, Shang LX, Wang LN, Wang YL, Chen J, Jiang SS: Clinical observation on diabetic peripheral neuropathy treated with electroacupuncture and acupoint injection. Zhongguo Zhen Jiu 2011, 31:613-616.
• [11]Irnich D, Winklmeier S, Beyer A, Peter K: Electric stimulation acupuncture in peripheral neuropathic pain syndromes. Clinical pilot study on analgesic effectiveness. Schmerz 2002, 16:114-120.
• [12]Galantino ML, Eke-Okoro ST, Findley TW, Condoluci D: Use of noninvasive electroacupuncture for the treatment of HIV-related peripheral neuropathy: a pilot study. J Altern Compl Med 1999, 5:135-142.
• [13]Bao T, Zhang R, Badros A, Lao L: Acupuncture treatment for bortezomib-induced peripheral neuropathy: a case report. Pain Res Treat 2011, 2011:920807.
• [14]Wong R, Sagar S: Acupuncture treatment for chemotherapy-induced peripheral neuropathy - a case series. Acupunct Med 2006, 24:87-91.
• [15]Minton O, Higginson IJ: Electroacupuncture as an adjunctive treatment to control neuropathic pain in patients with cancer. J Pain Symptom Manage 2007, 33:115-117.
• [16]Donald GK, Tobin I, Stringer J: Evaluation of acupuncture in the management of chemotherapy-induced peripheral neuropathy. Acupunct Med 2011, 29:230-233.
• [17]Xu WR, Hua BJ, Hou W, Bao YJ: Clinical randomized controlled study on acupuncture for treatment of peripheral neuropathy induced by chemotherapeutic drugs. Zhongguo Zhen Jiu 2010, 30:457-460.
• [18]Schroeder S, Meyer-Hamme G, Epplee S: Acupuncture for chemotherapy-induced peripheral neuropathy (CIPN): a pilot study using neurography. Acupunct Med 2012, 30:4-7.
• [19]Paley CA, Johnson MI, Tashani OA, Bagnall AM: Acupuncture for cancer pain in adults. Cochrane Database Syst Rev 2011, 19:CD007753.
• [20]Text book committee of Korean Acupuncture and Moxibustion Society: The Acupuncture and Moxibustion. 2nd edition. Paju: Jipmoondang; 2008.
• [21]Postma TJ, Aaronson NK, Heimans JJ, Muller MJ, Hildebrand JG, Delattre JY, Hoang-Xuan K, Lanteri-Minet M, Grant R, Huddart R, Moynihan C, Maher J, Lucey R: The development of an EORTC quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy: the QLQ-CIPN20. Eur J Canc 2005, 41:1135-1139.
• [22]Giorgi F, Cellerino R, Gramazio A, Tummarello D, Menichetti ET, Giordani P, Antognoli S, Carle F, Piga A: Assessing quality of life in patients with cancer: a comparison of a visual-analogue and a categorical model. Am J Clin Oncol 1996, 19:394-399.
• [23]Hyland ME, Sodergren SC: Development of a new type of global quality of life scale, and comparison of performance and preference for 12 global scales. Qual Life Res 1996, 5:469-480.
• [24]Lee JJ, Low JA, Croarkin E, Parks R, Berman AW, Mannan N, Steinberg SM, Swain SM: Changes in neurologic function tests may predict neurotoxicity caused by ixabepilone. J Clin Oncol 2006, 24:2084-2091.
• [25]Cavaletti G, Cornblath DR, Merkies IS, Postma TJ, Rossi E, Frigeni B, Alberti P, Bruna J, Velasco R, Argyriou AA, Kalofonos HP, Psimaras D, Ricard D, Pace A, Galie E, Briani C, Dalla Torre C, Faber CG, Lalisang RI, Boogerd W, Brandsma D, Koeppen S, Hense J, Storey D, Kerrigan S, Schenone A, Fabbri S, Valsecchi MG: The chemotherapy-induced peripheral neuropathy outcome measures standardization study: from consensus to the first validity and reliability findings. Ann Oncol 2013, 24:454-462.
• [26]Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, Kaasa S, Klee M, Osoba D, Razavi D, Rofe PB, Schraub S, Sneeuw K, Sullivan M, Takeda F: The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Canc Inst 1993, 85:365-376.
• [27]Guyatt GH, Osoba D, Wu AW, Wyrwich KW, Norman GR: Methods to explain the clinical significance of health status measures. Mayo Clin Proc 2002, 77:371-383.
• [28]Hertzog MA: Considerations in determining sample size for pilot studies. Res Nurs Health 2008, 31:180-191.
• [29]Julious SA: Sample size of 12 per group rule of thumb for a pilot study. Pharm Stat 2005, 4:287-291.
• [30]Wickham R: Chemotherapy-induced peripheral neuropathy: a review and implications for oncology nursing practice. Clin J Oncol Nurs 2007, 11:361-376.
• [31]Schroder S, Liepert J, Remppis A, Greten JH: Acupuncture treatment improves nerve conduction in peripheral neuropathy. Eur J Neurol 2007, 14:276-281.
• [32]Schroeder S, Remppis A, Greten T, Brazkiewicz F, Morcos M, Greten HJ: Quantification of acupuncture effects on peripheral neuropathy of unknown and diabetic cause by nerve conduction studies. J Acupunct Tuina Sci 2008, 6:3.