TheraBionic - Model P1 device - Low Levels Radiofrequency (RF) Electromagnetic Device
The TheraBionic P1 produces low levels radiofrequency (RF) electromagnetic fields, which are amplitude-modulated at tumor-specific frequencies. The device is coupled with a spoon-shaped antenna, which is placed in the patient’s mouth, more precisely on the anterior part of the patient’s tongue for three sixty-minute sessions per day. When the spoon-shaped antenna is placed on the patient’s tongue, it delivers low levels of radiofrequency electromagnetic fields throughout the patient’s body.
Details
The TheraBionic P1 emits low levels of radiofrequency electromagnetic fields and the levels delivered during treatment are lower than those generated by cellular phones when held close to the body. No serious adverse events have ever been reporting with the use of the TheraBionic P1 device, even after more than six years of continuous use.
In an investigator-initiated, single-group, single-center, non-randomized, phase I/II study in patients with advanced HCC, Costa and collaborators assessed the safety and effectiveness of treatment of advanced hepatocellular carcinoma with HCC-specific modulation frequencies of low energy radiowaves.(Costa, de Oliveira et al. 2011) Patients with advanced HCC with or without metastases, diagnosed by imaging or biopsy, age 18 years or older with an ECOG performance status of 0 to 2 and with permanently impaired liver function were eligible for enrollment. Previous local or systemic treatments with sorafenib or chemotherapy were allowed. Forty-one patients with advanced HCC and Child Pugh A or B disease and limited therapeutic options received intervention (6 females, 35 males; median age: 64 years; range: 18 – 85; BCLC status B: n=6, BCLC status C: n=35). Thirty-one patients (75.6%) had radiological evidence of disease progression at the time of enrollment as defined by comparison of baseline imaging studies with imaging studies obtained within the previous six months. Thirty-four (82.9%) patients had received therapy prior to enrollment, 25 of them chemoembolization. Seven (17.1%) patients had not received therapy prior to enrollment because of (1) severely impaired liver function in five cases, or (2) refusal to receive chemotherapy for metastatic disease.
The HCC treatment program consisted of sequential emission of repeated cycles of 194 HCC-specific modulation frequencies identified by the methods described in Barbault et al.(Barbault, Costa et al. 2009) for 60 min, three times daily. Treatment with the device was administered until disease progression or death. Imaging studies were performed every 8 weeks. Patients were treated in two sequential cohorts. After the first cohort (n=23) showed encouraging results (Progression-free survival ≥ 6 months: n = 6), the second cohort (n=18) was enrolled.
The primary end point was the proportion of patients who were progression-free at 6 months. Secondary end points were median progression-free survival (PFS) (first day of treatment until progression of disease or death) and median overall survival (OS) (first day of receiving treatment to death).
Of the 41 patients, 14 patients (34.1%) had stable disease (SD) for more than 6 months, which met the preplanned primary efficacy criterion of 8 patients with progression-free survival of at least 6 months. Median progression-free survival was 4.4 months (95% CI 2.1–5.3) and median OS was 6.7 months (95% CI 3.0–10.2). Estimated survival at 12, 24 and 36 months was 27.9% (s.e. = 7.1%), 15.2% (s.e. = 5.7%), and 10.1% (s.e. = 4.8%), respectively. Overall, there were six long-term survivors with an OS greater than 24 months and four long-term survivors with an OS greater than 3 years. Importantly, five of the six (83%) long-term survivors had radiological evidence of disease progression at the time of study enrolment. Two of three patients with the longest survival (44.6 and +58 months) had radiological evidence of disease progression at the time of enrolment, and BLCL stage C disease. The latter patient remained on therapy with a near complete response for 58 months.
In all, 11 patients reported pain before treatment initiation, 3 patients reported grade 3, 5 patients reported grade 2, and 3 patients grade 1 pain. After initiation of treatment, five (45.5%) patients reported complete disappearance of pain and two (18.2%) patients reported decreased pain. Two patients reported no changes and two patients reported increased pain. Hence, 63.6% of patients with cancer-related pain experienced symptomatic benefit.
Tumor shrinkage as assessed by radiological imaging as well as changes in AFP levels were documented in patients with advanced HCC receiving RF EMF modulated at HCC-specific frequencies administered by the intrabuccal probe. Antitumor activity in patients with advanced HCC was exemplified by partial responses observed in four patients (9.8%) and decreases in AFP levels greater than 20% in four patients. A total of 18 patients (43.9%) either had objective response or SD for greater than 6 months. Importantly, clinical benefit also was observed in patients with Child Pugh B disease, i.e., patients with severely impaired liver function who tolerate poorly antitumor treatment with drugs such as sorafenib (Nexavar®), Lenvatinib (Lenvima®) or regorafenib (Stivarga®).
These results were compared with results by Abou-Alfa et al.(Abou-Alfa, Schwartz et al. 2006): In a large phase II study assessing the effects of Sorafenib in patients with HCC and Child–Pugh A and B who had not received previous systemic treatment, Abou-Alfa et al. observed partial responses using the WHO criteria in 2.2% of patients. This compares to 9.8% with the TheraBionic device, which is an about fourfold higher percentage. Investigator-assessed median time to progression in the Sorafenib study was 4.2 months, and median OS was 9.2 months. Of note, all 137 patients from that study had evidence of disease progression after 14.8 months. At the same time point, four (9.8%) of the patients enrolled in the TheraBionic study did not have evidence of disease progression. These findings suggest that the TheraBionic device may increase the time to radiological progression in advanced HCC. Importantly, the ratio of Child-Pugh A patients vs. Child-Pugh B patients was higher in the Abou-Alpha et al. study(Abou-Alfa, Schwartz et al. 2006) than in the Costa et al. study.(Costa, de Oliveira et al. 2011) Thus, better outcome in the Costa et al. study cannot, therefore, be attributed to better general physical condition.
Use of the TheraBionic P1
The TheraBionic P1 is indicated for the systemic treatment of advanced hepatocellular carcinoma with or without metastases, diagnosed by imaging or biopsy, in patients age 18 years or older with an ECOG (Eastern Cooperative Oncology Group) performance of 0 to 2 who have exhausted all curative treatment options:
- whose disease has progressed while receiving first line treatment with sorafenib*, and second line treatment with regorafenib and/or immunotherapy; or,
- who cannot tolerate sorafenib, regorafenib or immunotherapy* because of intolerable side effects; and,
- with at least one liver lesion measurable by RECIST and permanently impaired liver function defined as: MELD score up to 29, BCLC Stage B and C, or Child-Pugh Class A or B.
or lenvatinib (On June 28, 2018, the European Medicines Agency (EMA) and on August 16, 2018, the Food and Drug Administration approved lenvatinib (Lenvima®, Eisai Inc.) for first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).
The TheraBionic P1 emits low levels of radiofrequency electromagnetic fields, which block the growth of tumor cells and do not affect the growth of normal cells. Even with clinical experience limited to 51 patients, there is preliminary evidence that TheraBionic P1 is a low risk device, which may increase progression-free survival and overall survival when used for three 60-minute treatments daily.
General Description
- Device carrying case
- TheraBionic P1 Therapeutic Device
- TheraBionic P1 Docking Station for battery recharging and activation card insertion
- Coaxial cable (1.2 m) with patient spoon
- Power supply for Docking Station
- Activation Card
- Instruction for use (in upper part of device carrying case)
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