title: Magnetic field therapy in patients with cytostatics-induced polyneuropathy: A prospective randomized placebo-controlled phase-III study.
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.
authors.affiliation: Klinik Reinhardshöhe, Medical Center of Cancer Rehabilitation, Bad Wildungen, Germany.
authors.forename: Oliver
authors.initials: O
authors.lastname: Rick
authors.affiliation: Institute of Medical Statistics, Kiel, Germany.
authors.forename: Ulrike
authors.initials: U
authors.lastname: von Hehn
authors.affiliation: Klinik Reinhardshöhe, Medical Center of Cancer Rehabilitation, Bad Wildungen, Germany.
authors.forename: Eberhard
authors.initials: E
authors.lastname: Mikus
authors.affiliation: Karlsruher Institute of Technology (KIT), Eggenstein-Leopoldshafen, Germany.
authors.forename: Hermann
authors.initials: H
authors.lastname: Dertinger
authors.affiliation: Klinik Reinhardshöhe, Medical Center of Cancer Rehabilitation, Bad Wildungen, Germany.
authors.forename: Georg
authors.initials: G
authors.lastname: Geiger
mesh_terms: D000328:Adult; D000368:Aged; D054697:Cytostatic Agents / Q000009:adverse effects*; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D055909:Magnetic Field Therapy; D008297:Male; D008875:Middle Aged; D011115:Polyneuropathies / Q000139:chemically induced* / Q000628:therapy*; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D054697:Cytostatic Agents
keywords: CIPN; cancer rehabilitation; chemotherapy; magnetic field therapy; polyneuropathy