Last updated 2 years ago
Determination of Autonomic Responses to the Exposure of Low Energy Electromagnetic Fields With Frequency Modulation in Patients With Advanced Hepatocellular Carcinoma and Healthy Individuals.
60 patients around the world
Available in Brazil
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.
Hospital Sirio-Libanes
1Research sites
60Patients around the world
This study is for people with
Liver Cancer
Hepatocellular Carcinoma
Requirements for the patient
To 80 Years
All Gender
Medical requirements
- Healthy volunteersMust 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 carcinomaPatients 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.
- Individuals selected for this study will be excluded if they meet the following exclusion criteria:They cannot stop antihypertensive drugs or beta blockers for at least 24 hours.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.
Sites
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
Recruiting
StudyHSL 2016-83
SponsorHospital Sirio-Libanes
Conditions
Hepatocellular Carcinoma
Requirements
To 80 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT03448757
