Determination of Autonomic Responses to the Exposure of Low Energy Electromagnetic Fields With Frequency Modulation in Patients With Advanced Hepatocellular Carcinoma and Healthy Individuals.

Hepatocellular Carcinoma Clinical Trial

Official title: Determination of Autonomic Responses to the Exposure of Low Energy Electromagnetic Fields With Frequency Modulation in Patients With Advanced Hepatocellular Carcinoma and Healthy Individuals.

Status Recruiting

Clinical Trial Summary

Biofeedback is an autonomic response observed during the exposure period to CEMBE. After prospectively evaluating 20 healthy individuals or 40 patients with advanced breast cancer or hepatocarcinoma, it was possible to determine subtle hemodynamic changes consistent with the biofeedback effect associated with exposure to a cancer-specific set of modulated frequencies. Once CEMBE is administered through an intra-oral administration device, the human body absorbs the energy applied at the level of 0.2-1 mW / kg, with a peak absorption in 10 g of tissue between 55 and 132 mW / kg. Initially, the discriminatory study analyzing 9 hemodynamic parameters recorded beat heart beat in 18 individuals demonstrated a hemodynamic pattern specific for hepatocarcinoma and breast cancer, with sensitivity of 94.1% and 95%, respectively, and specificity of 75% and 95%, respectively. These findings were validated in blind analysis in the remaining 56 patients, confirming the high rate of discriminatory success. A specific pattern of response associated with exposure of a cancer-specific frequency group was also observed in patients diagnosed with neoplasia, since the control group of healthy individuals did not present these response patterns. This specific signature of response to CEMBE-modulated exposure to cancer-specific frequencies was significantly altered only in patients with hepatocarcinoma after tumor withdrawal (Costa et al, 2015a).

Clinical Trial Description

This is an exploratory, national, unicentric, open study, to be conducted at the Instituto de Ensino e Pesquisa do Hospital Sírio Libanês, aiming to determine a method of prospective measurement of autonomic responses resulting from exposure to LEEF modulated at specific frequencies and with sequential exposure (frequency to frequency) in healthy individuals and patients with advanced hepatocellular carcinoma , followed by new exposure with a new set of specific frequencies determined by mathematical method. This study aims to create a method for non-invasive diagnosis of biofeedback effect exposure to LEEF modulated to specific frequencies in individuals exposed to hepatocellular carcinoma -specific frequencies in increasing sequential manner, frequency to frequency in patients with advanced hepatocellular carcinoma and healthy individuals. Patients with advanced hepatocellular carcinoma will be exposed to specific LEEF-modulated frequencies (3 to 10 Hz difference) to identify the optimal frequency associated with greater response to the biofeedback effect in patients with advanced hepatocellular carcinoma. Patients with advanced hepatocellular carcinoma will be exposed to modulated LEEF at a new set of specific frequencies determined by mathematical method to identify biofeedback effect in patients with advanced hepatocellular carcinoma. This study does not propose to study a therapeutic procedure. For this reason, no evolutionary clinical data will be analyzed during and after study intervention. This study will be conducted in an outpatient setting and is expected to last 24 months. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

• NCT number: NCT03448757
• Study type: Interventional
• Source: Hospital Sirio-Libanes
• Contact: Frederico Costa, MD
• Phone: 5511996737593
• Email: fredericoperegocosta@gmail.com
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2018
• Completion date: December 16, 2023