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, 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.

Low frequency magnetic field therapy in patients with cytostatic-induced polyneuropathy: a phase II pilot study.

Cytostatic-induced polyneuropathy (CIPN) is a common and serious toxicity in tumor patients. Treatment and prophylactic measures are mainly ineffective. Therefore, there is an urgent need to establish a sufficient therapy for pPNP. Between July 2007 and August 2008, 20 patients were treated with low frequency (4-12 Hz) magnetic field therapy (MFT), and neurological examinations were conducted at the trial therapy's beginning, as well as after 3-4 weeks. Standardized testing methods were applied, i.e., the Common Toxicity Criteria questionnaire of the National Cancer Institute and the measurement of nerve conduction velocity (NCV) in the electrophysiological examination. In terms of the components sensory ataxia and neuropathy as well as neuropathic pain, an improvement was achieved using MFT. This effect was confirmed by an increase in NCV. Using low frequency MFT, CIPN was influenced positively on both hands and feet. This could represent a future therapy principle for these patients.

Potent stimulation of blood flow in fingers of volunteers after local short-term treatment with low-frequency magnetic fields from a novel device.

A novel hand-held low-frequency magnetic stimulator (MagCell-SR) was tested for its ability to stimulate microcirculation in fingers of healthy volunteers. Blood flow during and after 5 minutes exposure was quantified using Laser Doppler Perfusion Imaging Technique. The device was positioned between the wrist and the dorsal part of the backhand. Because the increase in blood flow could be caused by a release of nitric oxide (NO) from the vascular endothelial cells we tested NO production with a fluorescence marker and quantified the measurements in cell cultures of human umbilical endothelial cells (HUVEC). Exposure increased blood flow significantly, persisted several minutes, and then disappeared gradually. In order to assess the effect of a static magnetic field, the measurements were also carried out with the device shutoff. Here, only a small increase in blood flow was noted. The application of the rotating MagCell-SR to the HUVEC cultures leads to a rapid onset and a significant increase of NO release after 15 minutes. Thus, frequencies between 4 and 12 Hz supplied by the device improve microcirculation significantly. Therefore, this device can be used in all clinical situations where an improvement of the microcirculation is useful like in chronic wound healing deficits.

Microstructured scaffolds for liver tissue cultures of high cell density: morphological and biochemical characterization of tissue aggregates.

Very high cell densities and optimal vascularization characterize among others organs and tissues in vivo. In order to study organ-specific functions in vitro or to make use of them in medical devices/treatments in the future, this natural architecture should be rebuilt. An important aspect in this context is the appropriate ratio of medium to cell volume being so far not optimally reestablished in most of the currently available in vitro systems. To improve such culture conditions, we constructed a microstructure to culture hepatocytes and (without any addition of extracellular matrix material) characterized liver tissue in the form of evenly sized aggregates. The liver-specific differentiation status of such aggregates was monitored by their ability to perform CYP450 dependent xenobiotic metabolism along with the measurement of albumin secretion. Freshly isolated adult rat hepatocytes show an initial loss of total CYP450 content and of associated activities (mixed function oxidases). However, in the aggregate system, this level did not decrease further but remained stable or even increased throughout the culture period of 10-13 days. The CYP450 dependent metabolism of the hepatocytes is able to respond to classic inducing agents. The described culture efficiently supports liver-specific functions of adult rat hepatocytes and seems to be suited not only for use in an extracorporeal liver device but also for the formation of evenly sized small aggregates to be of use in transplantation of differentiated liver tissue. Moreover, after design variations, the microstructure can be applied for functional analysis of metabolically active hepatocytes as well as for toxicological and pharmacological validation.