Researchers at Wake Forest School of Medicine have shown that targeted therapy using non-thermal radio waves can be used safely in the treatment of hepatocellular carcinoma (HCC), the most common type of liver cancer. The team’s findings, published in the journal 4Open, also indicate an improvement in overall survival.
“HCC accounts for nearly 90% of all liver cancers, and current survival rates are between six and 20 months,” said Boris Pasche, chair of cancer biology and director of Wake Forest Baptist Comprehensive Cancer Center. . “Currently, treatment options for patients with this advanced liver cancer are limited.”
For the study, the researchers used a handheld device called TheraBionic P1, invented by Pasche and Alexandre Barbault of TheraBionic, which works by delivering cancer-specific amplitude modulated radiofrequency electromagnetic fields (AM RF EMF) programmed specifically for HCC. . The frequencies used are specific to the patient’s cancer type, identified by tumor biopsies or blood tests, with Pasche and Barbault finding radio frequencies for 15 different cancer types in 2009.
TheraBionic P1 emits radio frequencies via a spoon-shaped antenna, which is placed on the patient’s tongue during treatment and is administered three times daily for one hour to deliver low levels of radiofrequency electromagnetic fields throughout the patient’s body . In previous studies, the device – which received breakthrough designation from the FDA in 2019 – was shown to block the growth of liver cancer cells in the body without damaging healthy cells.
For the current study, 18 patients with advanced HCC participated and received treatment with the device. The researchers also analyzed previously published data on 41 patients from a phase 2 study and historical controls from previous clinical trials.
“Our results show an improvement in overall survival of more than 30% in patients with well-preserved liver function and also in those with more severe disease,” Pasche said. Researchers also tracked side effects, and no patients discontinued TheraBionic P1 treatment due to adverse effects.
“We are encouraged by these initial results,” Pasche said. “Our study shows an overall survival benefit, and the treatment is not associated with any significant side effects.”
Pasche noted that the study has several limitations due to the small sample size and the “selection bias inherent in using historical control data.” However, two additional clinical trials are currently underway: one is a single-center study to assess the safety and efficacy of the TheraBionic device in combination with Regorafenib, a chemotherapy drug, as a second-line treatment; the other is a randomized, multicenter, double-blind study comparing TheraBionic to placebo to assess the safety and efficacy of the device as third-line therapy in the treatment of advanced HCC.
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