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Botulinum Toxin A for the Treatment of Chemotherapy Induced Peripheral Neuropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT03571334

Recruitment Status : Recruiting

First Posted : June 27, 2018

Last Update Posted : December 23, 2021

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View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Erin McGonigle, Medical College of Wisconsin

No Study Results Posted on ClinicalTrials.gov for this Study

About Study Results Reporting on ClinicalTrials.gov

Recruitment Status :	Recruiting
Estimated Primary Completion Date :	December 31, 2023
Estimated Study Completion Date :	December 31, 2024

Publications:

Apfel SC. Botulinum toxin for neuropathic pain? Neurology. 2009 Apr 28;72(17):1456-7. doi: 10.1212/WNL.0b013e3181a412b2. Epub 2009 Mar 25. No abstract available.

Argyriou AA, Bruna J, Marmiroli P, Cavaletti G. Chemotherapy-induced peripheral neurotoxicity (CIPN): an update. Crit Rev Oncol Hematol. 2012 Apr;82(1):51-77. doi: 10.1016/j.critrevonc.2011.04.012. Epub 2011 Sep 10.

Bouhassira D, Attal N, Alchaar H, Boureau F, Brochet B, Bruxelle J, Cunin G, Fermanian J, Ginies P, Grun-Overdyking A, Jafari-Schluep H, Lanteri-Minet M, Laurent B, Mick G, Serrie A, Valade D, Vicaut E. Comparison of pain syndromes associated with nervous or somatic lesions and development of a new neuropathic pain diagnostic questionnaire (DN4). Pain. 2005 Mar;114(1-2):29-36. doi: 10.1016/j.pain.2004.12.010. Epub 2005 Jan 26.

Cui M, Khanijou S, Rubino J, Aoki KR. Subcutaneous administration of botulinum toxin A reduces formalin-induced pain. Pain. 2004 Jan;107(1-2):125-33. doi: 10.1016/j.pain.2003.10.008.

Fan C, Chu X, Wang L, Shi H, Li T. Botulinum toxin type A reduces TRPV1 expression in the dorsal root ganglion in rats with adjuvant-arthritis pain. Toxicon. 2017 Jul;133:116-122. doi: 10.1016/j.toxicon.2017.05.001. Epub 2017 May 3.

Favre-Guilmard C, Auguet M, Chabrier PE. Different antinociceptive effects of botulinum toxin type A in inflammatory and peripheral polyneuropathic rat models. Eur J Pharmacol. 2009 Sep 1;617(1-3):48-53. doi: 10.1016/j.ejphar.2009.06.047. Epub 2009 Jul 1. Erratum In: Eur J Pharmacol. 2010 Feb 25;628(1-3):290.

Francisco GE, Tan H, Green M. Do botulinum toxins have a role in the management of neuropathic pain?: a focused review. Am J Phys Med Rehabil. 2012 Oct;91(10):899-909. doi: 10.1097/PHM.0b013e31825a134b.

Freeman R, Wallace MS, Sweeney M, Backonja MM. Relationships Among Pain Quality, Pain Impact, and Overall Improvement in Patients with Postherpetic Neuralgia Treated with Gastroretentive Gabapentin. Pain Med. 2015 Oct;16(10):2000-11. doi: 10.1111/pme.12791. Epub 2015 Jun 25.

Galer BS, Jensen MP. Development and preliminary validation of a pain measure specific to neuropathic pain: the Neuropathic Pain Scale. Neurology. 1997 Feb;48(2):332-8. doi: 10.1212/wnl.48.2.332.

Park HJ, Lee Y, Lee J, Park C, Moon DE. The effects of botulinum toxin A on mechanical and cold allodynia in a rat model of neuropathic pain. Can J Anaesth. 2006 May;53(5):470-7. doi: 10.1007/BF03022619.

Jensen MP, Friedman M, Bonzo D, Richards P. The validity of the neuropathic pain scale for assessing diabetic neuropathic pain in a clinical trial. Clin J Pain. 2006 Jan;22(1):97-103. doi: 10.1097/01.ajp.0000173018.64741.62.

Kottschade LA, Sloan JA, Mazurczak MA, Johnson DB, Murphy BP, Rowland KM, Smith DA, Berg AR, Stella PJ, Loprinzi CL. The use of vitamin E for the prevention of chemotherapy-induced peripheral neuropathy: results of a randomized phase III clinical trial. Support Care Cancer. 2011 Nov;19(11):1769-77. doi: 10.1007/s00520-010-1018-3. Epub 2010 Oct 9.

Lakhan SE, Velasco DN, Tepper D. Botulinum Toxin-A for Painful Diabetic Neuropathy: A Meta-Analysis. Pain Med. 2015 Sep;16(9):1773-80. doi: 10.1111/pme.12728. Epub 2015 Mar 20.

Lucioni A, Bales GT, Lotan TL, McGehee DS, Cook SP, Rapp DE. Botulinum toxin type A inhibits sensory neuropeptide release in rat bladder models of acute injury and chronic inflammation. BJU Int. 2008 Feb;101(3):366-70. doi: 10.1111/j.1464-410X.2007.07312.x.

Mols F, Beijers T, Vreugdenhil G, van de Poll-Franse L. Chemotherapy-induced peripheral neuropathy and its association with quality of life: a systematic review. Support Care Cancer. 2014 Aug;22(8):2261-9. doi: 10.1007/s00520-014-2255-7. Epub 2014 May 1.

Park J, Park HJ. Botulinum Toxin for the Treatment of Neuropathic Pain. Toxins (Basel). 2017 Aug 24;9(9):260. doi: 10.3390/toxins9090260.

Park SB, Krishnan AV, Lin CS, Goldstein D, Friedlander M, Kiernan MC. Mechanisms underlying chemotherapy-induced neurotoxicity and the potential for neuroprotective strategies. Curr Med Chem. 2008;15(29):3081-94. doi: 10.2174/092986708786848569.

Rao RD, Michalak JC, Sloan JA, Loprinzi CL, Soori GS, Nikcevich DA, Warner DO, Novotny P, Kutteh LA, Wong GY; North Central Cancer Treatment Group. Efficacy of gabapentin in the management of chemotherapy-induced peripheral neuropathy: a phase 3 randomized, double-blind, placebo-controlled, crossover trial (N00C3). Cancer. 2007 Nov 1;110(9):2110-8. doi: 10.1002/cncr.23008.

Rostami R, Mittal SO, Radmand R, Jabbari B. Incobotulinum Toxin-A Improves Post-Surgical and Post-Radiation Pain in Cancer Patients. Toxins (Basel). 2016 Jan 13;8(1):22. doi: 10.3390/toxins8010022.

Segreto F, Marangi GF, Cerbone V, Persichetti P. The Role of Botulinum Toxin A in the Treatment of Raynaud Phenomenon. Ann Plast Surg. 2016 Sep;77(3):318-23. doi: 10.1097/SAP.0000000000000715.

Seretny M, Currie GL, Sena ES, Ramnarine S, Grant R, MacLeod MR, Colvin LA, Fallon M. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. Pain. 2014 Dec;155(12):2461-2470. doi: 10.1016/j.pain.2014.09.020. Epub 2014 Sep 23.

Lavoie Smith EM, Cohen JA, Pett MA, Beck SL. The validity of neuropathy and neuropathic pain measures in patients with cancer receiving taxanes and platinums. Oncol Nurs Forum. 2011 Mar;38(2):133-42. doi: 10.1188/11.ONF.133-142.

Chen WT, Yuan RY, Chiang SC, Sheu JJ, Yu JM, Tseng IJ, Yang SK, Chang HH, Hu CJ. OnabotulinumtoxinA improves tactile and mechanical pain perception in painful diabetic polyneuropathy. Clin J Pain. 2013 Apr;29(4):305-10. doi: 10.1097/AJP.0b013e318255c132.

Ghasemi M, Ansari M, Basiri K, Shaigannejad V. The effects of intradermal botulinum toxin type a injections on pain symptoms of patients with diabetic neuropathy. J Res Med Sci. 2014 Feb;19(2):106-11.

Neumeister MW. Botulinum toxin type A in the treatment of Raynaud's phenomenon. J Hand Surg Am. 2010 Dec;35(12):2085-92. doi: 10.1016/j.jhsa.2010.09.019.

Poole HM, Murphy P, Nurmikko TJ. Development and preliminary validation of the NePIQoL: a quality-of-life measure for neuropathic pain. J Pain Symptom Manage. 2009 Feb;37(2):233-45. doi: 10.1016/j.jpainsymman.2008.01.012. Epub 2008 Aug 3.

Yuan RY, Sheu JJ, Yu JM, Chen WT, Tseng IJ, Chang HH, Hu CJ. Botulinum toxin for diabetic neuropathic pain: a randomized double-blind crossover trial. Neurology. 2009 Apr 28;72(17):1473-8. doi: 10.1212/01.wnl.0000345968.05959.cf. Epub 2009 Feb 25.