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Magnetic field therapy in patients with cytostatics‐induced polyneuropathy: A prospective randomized placebo‐controlled phase‐III study
No causal treatment for chemotherapy‐induced peripheral neuropathy (CIPN) is known. Therefore, there is an urgent need to develop a therapy for CIPN. Only scarce clinical data are available concerning magnetic field therapy (MFT) in this context. We conducted a unicentric, randomized, double‐blind,...
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Published in: | Bioelectromagnetics 2017-02, Vol.38 (2), p.85-94 |
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description | No causal treatment for chemotherapy‐induced peripheral neuropathy (CIPN) is known. Therefore, there is an urgent need to develop a therapy for CIPN. Only scarce clinical data are available concerning magnetic field therapy (MFT) in this context. We conducted a unicentric, randomized, double‐blind, placebo‐controlled phase‐III trial of an MFT device versus placebo. In this study, we randomized 44 patients with CIPN to two treatment groups, where 21 patients were treated with MFT (Group 1) and 23 patients received placebo (Group 2). We evaluated the efficacy of MFT at baseline (T1), after 3 weeks of study treatment (T2), and after 3 months of study treatment (T3). The primary endpoint was nerve conduction velocity (NCV), while secondary endpoints were the Common Toxicity Criteria (CTCAE) score and the Pain Detect End Score at T3. Seventeen of the patients in Group 1 and 14 patients in Group 2 completed the respective study treatment. The primary endpoint, significant improvement of NCV at T3, was achieved by MFT (P = 0.015), particularly for sensory neurotoxicity of the peroneal nerve. Also, in respect to the secondary endpoints, significant improvement (P = 0.04) was achieved in terms of the patients’ subjectively perceived neurotoxicity (CTCAE score), but not of neuropathic pain (P = 0.11). From data in the randomized study presented here, a positive effect on the reduction of neurotoxicity can be assumed for the MFT device. Patients with sensory neurotoxicity in the lower limbs, especially, should therefore be offered this therapy. Bioelectromagnetics. 38:85–94, 2017. © 2016 The Authors. Bioelectromagnetics published by Wiley Periodicals, Inc. |
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Therefore, there is an urgent need to develop a therapy for CIPN. Only scarce clinical data are available concerning magnetic field therapy (MFT) in this context. We conducted a unicentric, randomized, double‐blind, placebo‐controlled phase‐III trial of an MFT device versus placebo. In this study, we randomized 44 patients with CIPN to two treatment groups, where 21 patients were treated with MFT (Group 1) and 23 patients received placebo (Group 2). We evaluated the efficacy of MFT at baseline (T1), after 3 weeks of study treatment (T2), and after 3 months of study treatment (T3). The primary endpoint was nerve conduction velocity (NCV), while secondary endpoints were the Common Toxicity Criteria (CTCAE) score and the Pain Detect End Score at T3. Seventeen of the patients in Group 1 and 14 patients in Group 2 completed the respective study treatment. The primary endpoint, significant improvement of NCV at T3, was achieved by MFT (P = 0.015), particularly for sensory neurotoxicity of the peroneal nerve. Also, in respect to the secondary endpoints, significant improvement (P = 0.04) was achieved in terms of the patients’ subjectively perceived neurotoxicity (CTCAE score), but not of neuropathic pain (P = 0.11). From data in the randomized study presented here, a positive effect on the reduction of neurotoxicity can be assumed for the MFT device. Patients with sensory neurotoxicity in the lower limbs, especially, should therefore be offered this therapy. Bioelectromagnetics. 38:85–94, 2017. © 2016 The Authors. Bioelectromagnetics published by Wiley Periodicals, Inc.</description><identifier>ISSN: 0197-8462</identifier><identifier>EISSN: 1521-186X</identifier><identifier>DOI: 10.1002/bem.22005</identifier><identifier>PMID: 27657350</identifier><language>eng</language><publisher>United States: Wiley Subscription Services, Inc</publisher><subject>Adult ; Aged ; cancer rehabilitation ; chemotherapy ; CIPN ; Cytostatic Agents - adverse effects ; Endpoint Determination ; Female ; Humans ; Magnetic Field Therapy ; Male ; Middle Aged ; Polyneuropathies - chemically induced ; Polyneuropathies - therapy ; polyneuropathy ; Prospective Studies ; Treatment Outcome</subject><ispartof>Bioelectromagnetics, 2017-02, Vol.38 (2), p.85-94</ispartof><rights>2016 The Authors. published by Wiley Periodicals, Inc.</rights><rights>2016 The Authors. Bioelectromagnetics published by Wiley Periodicals, Inc.</rights><rights>2017 Wiley Periodicals, Inc.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4765-ad6ce7f6ba2d88792a58468387428b435b20edb01c3cd53bd0a61e14319edd243</citedby><cites>FETCH-LOGICAL-c4765-ad6ce7f6ba2d88792a58468387428b435b20edb01c3cd53bd0a61e14319edd243</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fbem.22005$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fbem.22005$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>230,315,786,790,891,27957,27958,50923,51032</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27657350$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Rick, Oliver</creatorcontrib><creatorcontrib>von Hehn, Ulrike</creatorcontrib><creatorcontrib>Mikus, Eberhard</creatorcontrib><creatorcontrib>Dertinger, Hermann</creatorcontrib><creatorcontrib>Geiger, Georg</creatorcontrib><title>Magnetic field therapy in patients with cytostatics‐induced polyneuropathy: A prospective randomized placebo‐controlled phase‐III study</title><title>Bioelectromagnetics</title><addtitle>Bioelectromagnetics</addtitle><description>No causal treatment for chemotherapy‐induced peripheral neuropathy (CIPN) is known. Therefore, there is an urgent need to develop a therapy for CIPN. Only scarce clinical data are available concerning magnetic field therapy (MFT) in this context. We conducted a unicentric, randomized, double‐blind, placebo‐controlled phase‐III trial of an MFT device versus placebo. In this study, we randomized 44 patients with CIPN to two treatment groups, where 21 patients were treated with MFT (Group 1) and 23 patients received placebo (Group 2). We evaluated the efficacy of MFT at baseline (T1), after 3 weeks of study treatment (T2), and after 3 months of study treatment (T3). The primary endpoint was nerve conduction velocity (NCV), while secondary endpoints were the Common Toxicity Criteria (CTCAE) score and the Pain Detect End Score at T3. Seventeen of the patients in Group 1 and 14 patients in Group 2 completed the respective study treatment. The primary endpoint, significant improvement of NCV at T3, was achieved by MFT (P = 0.015), particularly for sensory neurotoxicity of the peroneal nerve. Also, in respect to the secondary endpoints, significant improvement (P = 0.04) was achieved in terms of the patients’ subjectively perceived neurotoxicity (CTCAE score), but not of neuropathic pain (P = 0.11). From data in the randomized study presented here, a positive effect on the reduction of neurotoxicity can be assumed for the MFT device. Patients with sensory neurotoxicity in the lower limbs, especially, should therefore be offered this therapy. Bioelectromagnetics. 38:85–94, 2017. © 2016 The Authors. Bioelectromagnetics published by Wiley Periodicals, Inc.</description><subject>Adult</subject><subject>Aged</subject><subject>cancer rehabilitation</subject><subject>chemotherapy</subject><subject>CIPN</subject><subject>Cytostatic Agents - adverse effects</subject><subject>Endpoint Determination</subject><subject>Female</subject><subject>Humans</subject><subject>Magnetic Field Therapy</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Polyneuropathies - chemically induced</subject><subject>Polyneuropathies - therapy</subject><subject>polyneuropathy</subject><subject>Prospective Studies</subject><subject>Treatment Outcome</subject><issn>0197-8462</issn><issn>1521-186X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>WIN</sourceid><recordid>eNp1kc9qFTEYxYMo9ra68AUk4EYX0-bPZCbXRaGWqhda3Ci4C5nku52U3MmYZFrGVV9A8Bl9EnO9tajgKnDyy-GcHISeUXJICWFHHWwOGSNEPEALKhitqGw-P0QLQpdtJeuG7aH9lK4IIVIS_hjtsbYRLRdkgb5d6MsBsjN47cBbnHuIepyxG_Cos4MhJ3zjco_NnEPKRTLpx-13N9jJgMVj8PMAUwwF7ufX-ASPMaQRTHbXgKMebNi4r1vQawNdKE9NGHIM3m_FXico0mq1wilPdn6CHq21T_D07jxAn96efTx9X51_eLc6PTmvTF2SV9o2Btp102lmpWyXTIvSUnLZ1kx2NRcdI2A7Qg03VvDOEt1QoDWnS7CW1fwAHe98x6nbgDWlZtRejdFtdJxV0E79fTO4Xl2GayVYLRu6NXh5ZxDDlwlSVhuXDHivBwhTUmUAyZkkS1rQF_-gV2GKQ6lXKCF4ceNNoV7tKFP-L0VY34ehRG1HVmVk9Wvkwj7_M_09-XvVAhztgBvnYf6_k3pzdrGz_AkJf7fA</recordid><startdate>201702</startdate><enddate>201702</enddate><creator>Rick, Oliver</creator><creator>von Hehn, Ulrike</creator><creator>Mikus, Eberhard</creator><creator>Dertinger, Hermann</creator><creator>Geiger, Georg</creator><general>Wiley Subscription Services, Inc</general><general>John Wiley and Sons Inc</general><scope>24P</scope><scope>WIN</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QG</scope><scope>7QL</scope><scope>7QO</scope><scope>7QP</scope><scope>7T5</scope><scope>7TK</scope><scope>7TM</scope><scope>7U7</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>P64</scope><scope>5PM</scope></search><sort><creationdate>201702</creationdate><title>Magnetic field therapy in patients with cytostatics‐induced polyneuropathy: A prospective randomized placebo‐controlled phase‐III study</title><author>Rick, Oliver ; von Hehn, Ulrike ; Mikus, Eberhard ; Dertinger, Hermann ; Geiger, Georg</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4765-ad6ce7f6ba2d88792a58468387428b435b20edb01c3cd53bd0a61e14319edd243</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Adult</topic><topic>Aged</topic><topic>cancer rehabilitation</topic><topic>chemotherapy</topic><topic>CIPN</topic><topic>Cytostatic Agents - adverse effects</topic><topic>Endpoint Determination</topic><topic>Female</topic><topic>Humans</topic><topic>Magnetic Field Therapy</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Polyneuropathies - chemically induced</topic><topic>Polyneuropathies - therapy</topic><topic>polyneuropathy</topic><topic>Prospective Studies</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Rick, Oliver</creatorcontrib><creatorcontrib>von Hehn, Ulrike</creatorcontrib><creatorcontrib>Mikus, Eberhard</creatorcontrib><creatorcontrib>Dertinger, Hermann</creatorcontrib><creatorcontrib>Geiger, Georg</creatorcontrib><collection>Open Access: Wiley-Blackwell Open Access Journals</collection><collection>Wiley Online Library</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Animal Behavior Abstracts</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Biotechnology Research Abstracts</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Bioelectromagnetics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Rick, Oliver</au><au>von Hehn, Ulrike</au><au>Mikus, Eberhard</au><au>Dertinger, Hermann</au><au>Geiger, Georg</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Magnetic field therapy in patients with cytostatics‐induced polyneuropathy: A prospective randomized placebo‐controlled phase‐III study</atitle><jtitle>Bioelectromagnetics</jtitle><addtitle>Bioelectromagnetics</addtitle><date>2017-02</date><risdate>2017</risdate><volume>38</volume><issue>2</issue><spage>85</spage><epage>94</epage><pages>85-94</pages><issn>0197-8462</issn><eissn>1521-186X</eissn><notes>ObjectType-Article-1</notes><notes>SourceType-Scholarly Journals-1</notes><notes>ObjectType-Feature-2</notes><notes>content type line 23</notes><notes>Conflicts of interest: As a consultant, Eberhard Mikus gets a fee from Physiomed.</notes><notes>Presented in parts at the German Society of Hematology and Oncology (DGHO) Congress 2014.</notes><abstract>No causal treatment for chemotherapy‐induced peripheral neuropathy (CIPN) is known. Therefore, there is an urgent need to develop a therapy for CIPN. Only scarce clinical data are available concerning magnetic field therapy (MFT) in this context. We conducted a unicentric, randomized, double‐blind, placebo‐controlled phase‐III trial of an MFT device versus placebo. In this study, we randomized 44 patients with CIPN to two treatment groups, where 21 patients were treated with MFT (Group 1) and 23 patients received placebo (Group 2). We evaluated the efficacy of MFT at baseline (T1), after 3 weeks of study treatment (T2), and after 3 months of study treatment (T3). The primary endpoint was nerve conduction velocity (NCV), while secondary endpoints were the Common Toxicity Criteria (CTCAE) score and the Pain Detect End Score at T3. Seventeen of the patients in Group 1 and 14 patients in Group 2 completed the respective study treatment. The primary endpoint, significant improvement of NCV at T3, was achieved by MFT (P = 0.015), particularly for sensory neurotoxicity of the peroneal nerve. Also, in respect to the secondary endpoints, significant improvement (P = 0.04) was achieved in terms of the patients’ subjectively perceived neurotoxicity (CTCAE score), but not of neuropathic pain (P = 0.11). From data in the randomized study presented here, a positive effect on the reduction of neurotoxicity can be assumed for the MFT device. Patients with sensory neurotoxicity in the lower limbs, especially, should therefore be offered this therapy. Bioelectromagnetics. 38:85–94, 2017. © 2016 The Authors. Bioelectromagnetics published by Wiley Periodicals, Inc.</abstract><cop>United States</cop><pub>Wiley Subscription Services, Inc</pub><pmid>27657350</pmid><doi>10.1002/bem.22005</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Adult Aged cancer rehabilitation chemotherapy CIPN Cytostatic Agents - adverse effects Endpoint Determination Female Humans Magnetic Field Therapy Male Middle Aged Polyneuropathies - chemically induced Polyneuropathies - therapy polyneuropathy Prospective Studies Treatment Outcome |
title | Magnetic field therapy in patients with cytostatics‐induced polyneuropathy: A prospective randomized placebo‐controlled phase‐III study |
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