Low energy amplitude modulated radiofrequency electromagnetic fields in combination with standard treatment or as monotherapy to show improvement in quality of life in patients with advanced hepatocellular carcinoma.

Abstract

290 Background: Hepatocellular carcinoma (HCC) is a fatal cancer without curative option for most patients. Hence the importance to improve health related quality of life (HRQoL). Amplitude-modulated radiofrequency electromagnetic fields (EMF), as a novel and non-toxic therapy, has potential for improving HRQoL in advanced HCC patients. Methods: An open-label, single center, prospective clinical protocol was performed in advanced HCC patients as an initial and salvage treatment modality. Systemic exposure to EMF was used in combination with a systemic conventional treatment or as a single treatment. A spoon-shaped antenna placed in the oral cavity delivered EMF over 90 minutes with monthly repetitions until death or consent withdrawal. The effect on HRQoL was the primary objective of this study. Patients answered the EORTC-C30 v3.0 questionnaires prior to every EMF exposure. Clinically meaningful change (CMC) and time to deterioration (TTD) for Global Health (QoL), Role Functioning (RF) and Physical Functioning (PF) were used in the analysis. Results: From March 2018 to April 2020, 55 advanced HCC patients were submitted to 373 EMF exposures. 41/55 (75%) patients had repetitive exposures (mean # 4, ranging from 2-16). 87% were male, median age was 67, 84% were BLCL-C, 16% were Child-Pugh B, 29% had extra-hepatic metastasis, 55% had failed previous treatment and 71% had documented radiological progression. 31(56%) patients received EMF in combination with systemic therapy (28 TKI and 3 anti-PDL1). 24 patients received EMF as a single treatment modality. The mean baseline score was 68.1 for QoL and 77.1 for RF and PF. 61%, 76% and 49% of patients experienced positive change in QoL, RF and PS scores immediately prior to the second exposure, respectively. +CMC was reported in 20%, 17% and 32% of patients, respectively for QoL, RF and PS. The median QoL TTD was not reached. The median RF TTD was 7.2 month and the median PF TTD was 11.9 month. The median RF TTD for patients in combination treatment was 11.4 months and in a single treatment was 13.5 month. The median PF TTD for patients in combination treatment was 12.8 months and in single treatment was 14.5 month. Conclusions: Advanced HCC patients showed positive changes in QoL, RF and PF HRQoL scores after single exposure to EMF. The benefit from EMF in HRQoL was durable both in combination with TKI or as a single modality in advanced HCC patients. These results support future development as a novel palliative treatment modality in advanced HCC patients. Clinical trial information: NCT 01686412.

Low-energy amplitude-modulated radiofrequency electromagnetic fields as a systemic treatment for cancer: Review and proposed mechanisms of action

“…The AutEMdev deploys personalized frequencies in each patient ( 6 – 8 ). In an open-label clinical feasibility study in patients with advanced HCC ( Table 2 ), personalized frequencies were identified in a 30-minute discovery phase using real-time multi-parameter haemodynamic monitoring.…”

“…Frequencies eliciting the best biofeedback responses, defined by the magnitude of increased amplitude and/or the number of beats with increased amplitude of the radial pulse, were selected as tumour-specific (5). A study using the AutEMdev involved real-time automated monitoring of multiple haemodynamic parameters employing the AutEMdev and a separate monitoring device (6)(7)(8). Specific envelope wave frequencies that induced subtle but reproducible alterations in haemodynamic regulation were then identified in each individual.…”

“…These findings led to initiation of a multicentre, double-blind, randomized study comparing the P1 device with a placebo device in patients with advanced HCC following unsuccessful treatment with at least two lines of conventional systemic therapy (Table 2) (5,16). The AutEMdev deploys personalized frequencies in each patient (6)(7)(8). In an open-label clinical feasibility study in patients with advanced HCC (Table 2), personalized frequencies were identified in a 30-minute discovery phase using real-time multi-parameter haemodynamic monitoring.…”

“…The selected frequencies were then applied in a subsequent 30-minute treatment phase. The subtle but reproductible haemodynamic alterations at personalized frequencies are hypothesized to represent a biological surrogate of antitumour activity (6)(7)(8). The studies using AutEMdev and P1 devices provided evidence for anti-tumour efficacy and/or maintained or improved health-related quality of life (HRQoL) in patients remaining on treatment (Table 2), and overall survival in the prospective study cohort was longer compared with a retrospective control cohort (5)(6)(7)(8)16).…”

“…The identification of specific amplitudemodulation frequencies is based on the physiological effects of exposure on excitable cells (5). This enables haemodynamic changes to be used as biomarkers of potentially therapeutic frequencies for particular cancers or for individual patients (6)(7)(8). We review evidence on the efficacy and safety of amplitude-modulated radiofrequency electromagnetic field (LEAM RF EMF) exposure in patients with HCC using these devices.…”