IMPROVEMENT IN OVERALL SURVIVAL AND QUALITY OF LIFE IN PATIENTS WITH ADVANCED HEPATOCELLULAR CARCINOMA EXPOSED TO LOW ENERGY AMPLITUDE MODULATED ELECTROMAGNETIC FIELDS

Background: Exposure to amplitude-modulated radiofrequency electromagnetic fields (AM RF EMF) may provide beneficial palliative treatment for patients with advanced HCC (HCC). Methods: A single-group, open-label, prospective study was performed to assess the safety, the impact on quality of life (QoL), and the overall survival (OS) associated with exposure to AM RF EMF in HCC patients. The survival data and historical control data comparison was planned. AM RF EMF exposure-related toxicity was assessed in 43 healthy controls and 42 HCC patients. An outpatient AM RF EMF procedure of 120 min was performed once for healthy controls and repeated every 30 days for HCC patients until QoL deterioration, death, or withdrawal of patient consent. EORTC-C30 v3.0 questionnaires were answered immediately before each AM RF EMF treatment. Results: Out of 42 HCC patients, 16 received AM RF EMF alone and 26 in combination with systemic standard therapy. Neither healthy controls nor HCC patients experienced any exposure-related limiting toxicity associated with AM RF EMF procedures. Considering 30 HCC patients with at least two exposures, 63.3% of them reported QoL improvement within 30 days after the first AM RF EMF. With a median follow-up of+264 days in the prospective study patients, the median OS was not reached after +341 days, which is significantly longer than the mOS of historical controls (p = 0.0091). Conclusion: A 120-min monthly AM RFE MF procedure was safe, well-tolerated and showed meaningful improvement in QoL and overall survival in comparison with historical control (NCT 01686412).