Randomized sham-controlled pilot trial of weekly electro-acupuncture for the prevention of taxane-induced peripheral neuropathy in women with early stage breast cancer
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To investigate the effect of electro-acupuncture (EA) as a non-pharmacological intervention to prevent or reduce chemotherapy-induced peripheral neuropathy (CIPN) in breast cancer patients undergoing chemotherapy of taxane. Women with stage I-III breast cancer scheduled to receive taxane therapy were randomized to receive a standardized protocol of 12 true or sham EA (SEA) weekly treatments concurrent with taxane treatment. Subjects completed the Brief Pain Inventory-Short Form (BPI-SF), Functional Assessment of Cancer Therapy-Taxane neurotoxicity subscale (FACT-NTX), and other assessments at baseline and weeks 6, 12, and 16. A total of 180 subjects were screened, 63 enrolled and 48 completed week 16 assessments. Mean age was 50 with 25 % white, 25 % black, and 43 % Hispanic; 52 % had no prior chemotherapy. At week 12, both groups reported an increase in mean BPI-SF worst pain score, but no mean differences were found between groups (SEA 2.8 vs. EA 2.6, P = .86). By week 16, the SEA group returned to baseline, while the EA group continued to worsen (SEA 1.7 vs. EA 3.4, P = .03). The increase in BPI-SF worst pain score was 1.62 points higher in the EA group than in the SEA group at week 16 (P = .04). In a randomized, sham-controlled trial of EA for prevention of taxane-induced CIPN, there were no differences in pain or neuropathy between groups at week 12. Of concern, subjects on EA had a slower recovery than SEA subjects. Future studies should focus on EA for treatment as opposed to prevention of CIPN.
KeywordsAcupuncture Electro-acupuncture Breast cancer Chemotherapy-induced peripheral neuropathy Taxane
Breast Cancer Research Foundation (to DLH), National Cancer Institute NCI K23CA141052 (to HG).
Compliance with ethical standards
The experiments performed in this study comply with all relevant laws in the United States. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Informed consent was obtained from all individual participants included in the study.
Conflict of interest
The authors declare that they have no conflicts of interest.
- 2.Hershman DL, Weimer LH, Wang A, Kranwinkel G, Brafman L, Fuentes D, Awad D, Crew KD (2011) Association between patient reported outcomes and quantitative sensory tests for measuring long-term neurotoxicity in breast cancer survivors treated with adjuvant paclitaxel chemotherapy. Breast Cancer Res Treat 125(3):767–774. doi: 10.1007/s10549-010-1278-0 CrossRefPubMedGoogle Scholar
- 6.Henderson IC, Berry DA, Demetri GD, Cirrincione CT, Goldstein LJ, Martino S, Ingle JN, Cooper MR, Hayes DF, Tkaczuk KH, Fleming G, Holland JF, Duggan DB, Carpenter JT, Frei E, Schilsky RL, Wood WC, Muss HB, Norton L (2003) Improved outcomes from adding sequential paclitaxel but not from escalating doxorubicin dose in an adjuvant chemotherapy regimen for patients with node-positive primary breast cancer. J Clin Oncol 21:976–983. doi: 10.1200/JCO.2003.02.063 CrossRefPubMedGoogle Scholar
- 7.Martin M, Ruiz A, Ruiz Borrego M, Barnadas A, Gonzalez S, Calvo L, Margeli Vila M, Anton A, Rodriguez-Lescure A, Segui-Palmer MA, Munoz-Mateu M, Dorca Ribugent J, Lopez-Vega JM, Jara C, Espinosa E, Mendiola Fernandez C, Andres R, Ribelles N, Plazaola A, Sanchez-Rovira P, Salvador Bofill J, Crespo C, Carabantes FJ, Servitja S, Chacon JI, Rodriguez CA, Hernando B, Alvarez I, Carrasco E, Lluch A (2013) Fluorouracil, doxorubicin, and cyclophosphamide (FAC) versus FAC followed by weekly paclitaxel as adjuvant therapy for high-risk, node-negative breast cancer: results from the GEICAM/2003-02 study. J Clin Oncol 31(20):2593–2599. doi: 10.1200/JCO.2012.46.9841 CrossRefPubMedGoogle Scholar
- 8.Martin M, Segui MA, Anton A, Ruiz A, Ramos M, Adrover E, Aranda I, Rodriguez-Lescure A, Grosse R, Calvo L, Barnadas A, Isla D, Martinez del Prado P, Ruiz Borrego M, Zaluski J, Arcusa A, Munoz M, Lopez Vega JM, Mel JR, Munarriz B, Llorca C, Jara C, Alba E, Florian J, Li J, Lopez Garcia-Asenjo JA, Saez A, Rios MJ, Almenar S, Peiro G, Lluch A, Investigators G (2010) Adjuvant docetaxel for high-risk, node-negative breast cancer. N Engl J Med 363(23):2200–2210. doi: 10.1056/NEJMoa0910320 CrossRefPubMedGoogle Scholar
- 11.Smith EM, Pang H, Cirrincione C, Fleishman S, Paskett ED, Ahles T, Bressler LR, Fadul CE, Knox C, Le-Lindqwister N, Gilman PB, Shapiro CL, Alliance for Clinical Trials in O (2013) Effect of duloxetine on pain, function, and quality of life among patients with chemotherapy-induced painful peripheral neuropathy: a randomized clinical trial. JAMA 309(13):1359–1367. doi: 10.1001/jama.2013.2813 CrossRefPubMedPubMedCentralGoogle Scholar
- 12.Hershman DL, Lacchetti C, Dworkin RH, Lavoie Smith EM, Bleeker J, Cavaletti G, Chauhan C, Gavin P, Lavino A, Lustberg MB, Paice J, Schneider B, Smith ML, Smith T, Terstriep S, Wagner-Johnston N, Bak K, Loprinzi CL (2014) Prevention and management of chemotherapy- induced peripheral neuropathy in survivors of adult cancers: American society of clinical oncology clinical practice guideline. J Clin Oncol 32:1941–1967. doi: 10.1200/JCO.2013.54.0914 CrossRefPubMedGoogle Scholar
- 13.Hammack JE, Michalak JC, Loprinzi CL, Sloan JA, Novotny PJ, Soori GS, Tirona MT, Rowland KM, Stella PJ, Johnson JA (2002) Phase III evaluation of nortriptyline for alleviation of symptoms of cis-platinum-induced peripheral neuropathy. Pain 98:195–203. doi: 10.1016/S0304-3959(02)00047-7 CrossRefPubMedGoogle Scholar
- 15.Rao RD, Flynn PJ, Sloan JA, Wong GY, Novotny P, Johnson DB, Gross HM, Renno SI, Nashawaty M, Loprinzi CL (2008) Efficacy of lamotrigine in the management of chemotherapy-induced peripheral neuropathy: a phase 3 randomized, double-blind, placebo-controlled trial, N01C3. Cancer 112(12):2802–2808. doi: 10.1002/cncr.23482 CrossRefPubMedGoogle Scholar
- 16.Rao RD, Michalak JC, Sloan JA, Loprinzi CL, Soori GS, Nikcevich DA, Warner DO, Novotny P, Kutteh LA, Wong GY, North Central Cancer Treatment G (2007) Efficacy of gabapentin in the management of chemotherapy-induced peripheral neuropathy: a phase 3 randomized, double-blind, placebo-controlled, crossover trial (N00C3). Cancer 110(9):2110–2118. doi: 10.1002/cncr.23008 CrossRefPubMedGoogle Scholar
- 17.Barton DL, Wos EJ, Qin R, Mattar BI, Green NB, Lanier KS, Bearden JD 3rd, Kugler JW, Hoff KL, Reddy PS, Rowland KM Jr, Riepl M, Christensen B, Loprinzi CL (2011) A double-blind, placebo-controlled trial of a topical treatment for chemotherapy-induced peripheral neuropathy: NCCTG trial N06CA. Support Care Cancer: Off J Multinatl Assoc Support Care Cancer 19(6):833–841. doi: 10.1007/s00520-010-0911-0 CrossRefGoogle Scholar
- 33.Bao T, Goloubeva O, Pelser C, Porter N, Primrose J, Hester L, Sadowska M, Lapidus R, Medeiros M, Lao L, Dorsey SG, Badros AZ (2014) A pilot study of acupuncture in treating bortezomib-induced peripheral neuropathy in patients with multiple myeloma. Integr Cancer Ther 13:396–404. doi: 10.1177/1534735414534729 CrossRefPubMedPubMedCentralGoogle Scholar
- 35.Lu W, Matulonis UA, Dunn JE, Lee H, Doherty-Gilman A, Dean-Clower E, Goodman A, Davis RB, Buring J, Wayne P, Rosenthal DS, Penson RT (2012) The feasibility and effects of acupuncture on quality of life scores during chemotherapy in ovarian cancer: results from a pilot, randomized sham-controlled trial. Acupunct Med 24:233–240. doi: 10.1089/acu.2012.0904 CrossRefGoogle Scholar
- 37.Dharmananda S (2002) Electro-acupuncture. Subhuti Dharmananda. http://www.itmonline.org/arts/electro.htm. Accessed 4 March 2016
- 39.Lin CC, Chen MC, Yu SN, Ju MS (2005) Chronic electrical stimulation of four acupuncture points on rat diabetic neuropathy. In: Conference proceedings: annual international conference of the IEEE Engineering in Medicine and Biology Society IEEE engineering in medicine and biology society annual conference, vol 4, pp 4271–4274. doi: 10.1109/iembs.2005.1615408
- 43.Arrieta Ó, Hernández-Pedro N, Fernández-González-Aragón MC, Saavedra-Pérez D, Campos-Parra AD, Ríos-Trejo MÁ, Cerón-Lizárraga T, Martínez-Barrera L, Pineda B, Ordóñez G, Ortiz-Plata A, Granados-Soto V, Sotelo J (2011) Retinoic acid reduces chemotherapy-induced neuropathy in an animal model and patients with lung cancer. Neurology 77:987–995. doi: 10.1212/WNL.0b013e31822e045c CrossRefPubMedPubMedCentralGoogle Scholar