Hepatocellular Carcinoma
Conditions
Keywords
LEEF, hemodynamic parameters, heart beat, biofeedback effect
Brief 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).
Detailed 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.
Interventions
OTHERmeasuring hemodynamic parameters heart beat to heart beat during single-frequency exposure
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.
Sponsors
Hospital Sirio-Libanes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
measuring hemodynamic parameters heart beat to heart beat during single-frequency exposure
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteers * Must be considered healthy, with no known relevant comorbidity. * Patients must not be carriers of active malignant neoplasm or have a history of malignant neoplasm. * Must be over 18 years old. * Must have the ability to understand and provide written Informed Consent. Patients with hepatocellular carcinoma * Patients must be diagnosed with inoperable HCC. * Presence of the primary or metastatic tumor at the time of the procedure. * Patients diagnosed with hepatic cirrhosis must be restricted to Child-Pugh A or B. * Patients with AFP\> 400 ng/ml and characteristic image do not need histopathological confirmation. However, in patients with serology for active B virus, this AFP value must be greater than 4000 ng/ml. The remaining patients must have histological confirmation of HCC. * Patients may be in observation or in the course of systemic or intra-hepatic treatment. * Must have the ability to understand and provide written Informed Consent.
Exclusion criteria
* Individuals selected for this study will be excluded if they meet the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| non-invasive hemodynamic parameter measurements during exposure AM RF EMF | 90 min on day 1 and day 2 | Identification of hemodymanic alterations induced by the exposure to low levels of amplitude modulation radiofrequency electromagnetic fields (AM RF EMF) in healthy individuals and patients with advanced hepatocellular carcinoma using Artificial Intelligence program to analyze the recorded data set collected by a high-precision and non-invasive hemodynamic monitor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamic alteration´s comparison among advanced cancer patients and healthy controls | 120 min (single procedure) | Comparison of hemodynamic alteration during exposure to a group of hepatocellular-specific AM RF EMF recorded in healthy individuals and patients with advanced hepatocellular carcinoma using Artificial Intelligence algorithms to compare the recorded data set collected by a high-precision and non-invasive hemodynamic monitor. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Searching for cancer-specific frequency modulation | 120 min (single procedure) | Identification of specifc hemodynamic alteration recorded during the exposure to a series of specific frequency modulations AM RF EMF recorded in healthy individuals and patients with advanced hepatocellular carcinoma using Artificial Intelligence program. |
Countries
Brazil
Contacts
Primary ContactFrederico Costa, MD
Outcome results
None listed