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

Trials

Volumn 14, Issue 1, 2013, Pages 1-7

  Kim, Joo Hee ^a,b   Kim, Eun Jung ^c   Seo, Byung Kwan ^b   Lee, Sanghun ^d   Lee, Seunghoon ^a,b   Jung, So Young ^a   Lee, Min Hee ^a   Kim, Ae Ran ^a   Park, Hyo Ju ^a   Shin, Mi Suk ^a   Choi, Sun Mi ^a  

^a Korea Institute of Oriental Medicine (KIOM)   (South Korea)

^b Kyung Hee University   (South Korea)

^c Dongguk University   (South Korea)

^d Dankook University   (South Korea)

Author keywords

Chemotherapy induced peripheral neuropathy; Clinical research protocol; Effect; Electroacupuncture; Safety

Indexed keywords

ADULT; ARTICLE; CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY; CLINICAL ARTICLE; CLINICAL PROTOCOL; CONTROLLED STUDY; ELECTROACUPUNCTURE; FOLLOW UP; HUMAN; MULTICENTER STUDY; OUTCOME ASSESSMENT; PARALLEL DESIGN; PERIPHERAL NEUROPATHY; PILOT STUDY; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; TREATMENT DURATION; CHEMICALLY INDUCED DISORDER; CONTROLLED CLINICAL TRIAL; METHODOLOGY; NEUROLOGIC EXAMINATION; PREDICTIVE VALUE; SOUTH KOREA; TIME; TREATMENT OUTCOME;

ANTINEOPLASTIC AGENT;

ANTINEOPLASTIC AGENTS; CLINICAL PROTOCOLS; ELECTROACUPUNCTURE; HUMANS; NEUROLOGIC EXAMINATION; PERIPHERAL NERVOUS SYSTEM DISEASES; PILOT PROJECTS; PREDICTIVE VALUE OF TESTS; QUALITY OF LIFE; QUESTIONNAIRES; REPUBLIC OF KOREA; RESEARCH DESIGN; TIME FACTORS; TREATMENT OUTCOME;

EID: 84882590117     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-14-254     Document Type: Article

References (32)

1. Pachman DR, Barton DL, Watson JC, Loprinzi CL. Chemotherapy-induced peripheral neuropathy: prevention and treatment. Clin Pharmacol Ther 2011, 90:377-387. 10.1038/clpt.2011.115, 21814197.
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. 10.1111/j.1529-8027.2008.00156.x, 18346229.
4. Brittany MD. Chemotherapy-Induced Peripheral Neuropathy 2010, 7. NCI: Cancer Bulletin.
5. Wilkes G. Peripheral neuropathy related to chemotherapy. Semin Oncol Nurs 2007, 23:162-173. 10.1016/j.soncn.2007.05.001, 17693343.
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. 10.1200/JCO.2005.03.0106, 16421419.
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. 10.1111/j.1365-2141.2008.07573.x, 19170677.
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. 10.1002/cncr.23008, 17853395.
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. 10.1002/cncr.23482, 18428211.
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. 10.1007/s00482-001-0128-8, 11956896.
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. 3199913, 22110934.
14. Wong R, Sagar S. Acupuncture treatment for chemotherapy-induced peripheral neuropathy - a case series. Acupunct Med 2006, 24:87-91. 10.1136/aim.24.2.87, 16783284.
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. 10.1016/j.jpainsymman.2006.09.011, 17280917.
16. Donald GK, Tobin I, Stringer J. Evaluation of acupuncture in the management of chemotherapy-induced peripheral neuropathy. Acupunct Med 2011, 29:230-233. 10.1136/acupmed.2011.010025, 21875929.
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. 10.1136/acupmed-2011-010034, 22146780.
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 2008, Paju: Jipmoondang, 2, Text book committee of Korean Acupuncture and Moxibustion Society.
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. 10.1097/00000421-199608000-00016, 8677913.
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. 10.1007/BF00540019, 8973126.
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. 10.1200/JCO.2005.04.2820, 16648510.
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. 10.1093/annonc/mds329, 22910842.
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. 10.4065/77.4.371, 11936935.
28. Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health 2008, 31:180-191. 10.1002/nur.20247, 18183564.
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. 10.1188/07.CJON.361-376, 17623621.
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.