3698 - Exposure to low energy amplitude modulated radiofrequency electromagnetic fields (EMF) is associated with rapid improvement in quality of life (QoL) status in patients with advanced hepatocellular carcinoma (HCC), using various analyses of EORTC-C30.

Background

Patient-centered endpoints, overall survival (OS) and QoL (where the benefit is detectable by the patient as an improvement in symptoms or functional capacity), are considered valid “direct” endpoints by the FDA. While EORTC-C30 is an accepted indicator of QoL, there is no accepted standard for time to QoL status improvement, nor any accepted standard of analysis for EORTC-C30 data.

Methods

A single-group, open-label, feasibility study was performed to assess QoL status in HCC patients exposed to modulated EMF at patient-specific frequencies. A 120-min outpatient EMF exposure procedure was performed every 30 days until significant QoL deterioration or death. An oral spoon-shaped RF antenna applicator was used to apply EMF while individuals were kept in supine position. EORTC-C30 v3.0 questionnaires were answered by individuals immediately prior to every EMF exposure. The 17 QoL parameters were divided into those measuring improvement (G+ functional scales and global health status/QOL) and those measuring deterioration (G- symptom scales). QoL index was calculated as (mean G+) – (mean G-). Different QoL index calculations were made using three groups of QoL parameters: all 17 QoL parameters, 15 QoL parameters (removing Functional scales and Symptom scales) and 3 QoL parameters (restricted to Functional scales, Symptom scales and Global health status/QOL). A change of +/-5% in QoL index was considered a clinically relevant improvement/deterioration in QoL status.

Results

42 HCC were exposed to 151 EMF procedures. 4,530 QoL data points were collected for analysis, with 0.1% missing data. QoL index was measured at baseline and 30 days after the baseline exposure procedure. Using the 3 QoL index calculation methods (17 QoL, 15 QoL and 3 QoL) measured 30 days from the baseline exposure, QoL status improved in 63%, 59% and 74% of HCC patients respectively.

Conclusions

Rapid and significant improvement in QoL status in HCC patients exposed to EMF was detected within 30 days of exposure regardless of the QoL index calculation methods used.

Clinical trial identification

NCT 01686412.

Editorial acknowledgement

Luiz Fernando Reis PhD, Research Director Hospital Sírio Libanês, São Paulo, Brazil, Riad Younes MD and Bertram Wiedenmann PhD MD.

Legal entity responsible for the study

Hospital Sírio Libanês.

Funding

Has not received any funding.

Disclosure

F.P. Costa: Leadership role: Autem Medical. A. Iemma: Honoraria (institution): Autem Medical. F. Soares: Honoraria (institution): Autem Medical. J. Tuszynski: Advisory / Consultancy: Autem Medical. All other authors have declared no conflicts of interest.