Determination of Autonomic Responses to the Exposure of Low Energy Electromagnetic Fields With Frequency Modulation in Patients With Advanced Hepatocellular Carcinoma and Healthy Individuals.
NCT ID: NCT03448757
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2018-02-15
2023-12-16
Brief Summary
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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
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Autonomic response
Group for determination of biofeedback response - 40 individuals. For the formation of this study group of subjects, 20 healthy volunteers and 20 patients with advanced hepatocellular carcinoma will be selected and studied.
Group for determination of ideal frequency - 20 patients. For the formation of this study group of subjects, 20 patients with advanced hepatocellular carcinoma participants in the group will be selected and studied to determine biofeedback response.
Group for determination of new specific frequencies - 20 individuals. For the formation of this study group of subjects, 20 patients with advanced hepatocellular carcinoma not exposed to any specific frequency will be selected.
measuring 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.
Interventions
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measuring 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Have a pacemaker or other implantable device.
* Pregnant or breastfeeding.
* Under the age of 18.
* Patients undergoing radiotherapy or up to 2 weeks after its suspension.
* Inability to understand and provide written Informed Consent.
* Child Pugh C hepatic cirrhosis.
* Patient without definite diagnosis.
* Absence of primary or metastatic tumor at the time of the procedure.
Potentially eligible participants will be previously guided by the researcher on the objectives and risks of the study in question and will be presented and informed about the Free, Prior and Informed Consent document.
Only after all doubts related to the study have been clarified and the Free, Prior and Informed Consent document has been signed, will the study participant be invited and scheduled to attend the Oncology Center clinic of Hospital Sírio Libanês.
Patients must be informed that they may not drink alcohol up to 12 hours before the procedure, as there may be interference during the procedure.
They will also be advised not to use antihypertensive drugs like beta-blockers or calcium channel inhibitors 24 hours before the procedure, without resulting in a risk to the participant's health.
In this study, following or follow-up of patients is not foreseen.
18 Years
80 Years
ALL
Yes
Sponsors
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Hospital Sirio-Libanes
OTHER
Responsible Party
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Frederico Perego Costa
Principal investigator
Locations
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Hospital Sírio-Libanês
São Paulo, , Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HSL 2016-83
Identifier Type: -
Identifier Source: org_study_id