<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01686412</url>
  </required_header>
  <id_info>
    <org_study_id>HSL 2012/10</org_study_id>
    <nct_id>NCT01686412</nct_id>
  </id_info>
  <brief_title>Determination of Autonomic Responses to Exposure to Electromagnetic Fields With Low Energy Modulated Frequency</brief_title>
  <official_title>Determination of Autonomic Responses to Exposure to Electromagnetic Fields With Low Energy Modulated Frequency in Patients With Breast and Advanced Hepatocellular Cancer.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Sirio-Libanes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Sirio-Libanes</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an exploratory study, national, unicentric, double-blind, to be conducted at the&#xD;
      Institute for Teaching and Research of the Hospital Sírio-Libanês in order to detect possible&#xD;
      autonomic responses resulting from Exposure to Electromagnetic Fields of Low Energy (EEFLE)&#xD;
      in healthy subjects and in patients with advanced hepatocellular carcinoma or in patients&#xD;
      with advanced breast carcinoma. Autonomic responses have been described in patients with&#xD;
      cancer during the exposure of EEFLE. This autonomic response, or biofeedback, due to exposure&#xD;
      to EEFLE seems to be associated with a specific set of modulation frequencies when applied to&#xD;
      patients with malignancies. Moreover, healthy individuals exposed to modulated EEFLE a&#xD;
      specific set of frequency do not appear to autonomic response. Biofeedback is defined by a&#xD;
      change in amplitude of the radial pulse during exposure to EEFLE, modulated according to a&#xD;
      set of specific frequencies. This phenomenon is not yet fully elucidated. In exploratory&#xD;
      survey of one patient was observed a change of the pressure pulse immediately after the start&#xD;
      of and during exposure to EEFLE, modulated according to a set of specific frequencies&#xD;
      recorded by digital photoplethysmography. This study aims to evaluate an autonomic response&#xD;
      in individuals exposed in a single moment, by electromagnetic fields. This study does not&#xD;
      intend to study a diagnostic or therapeutic procedure. For this reason, evolutive clinical&#xD;
      data will not be considered during and after the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Autonomic response monitoring (blood pressure digital and manual monitoring)</measure>
    <time_frame>60 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular electronic monitoring (digital photoplethysmography and electrocardiography)</measure>
    <time_frame>60 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baroreflex sensitivity (by the method of sequence)</measure>
    <time_frame>60 minutes</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Healthy patients</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Oncology patients</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electromagnetic Fields of Low Energy (EEFLE)</intervention_name>
    <description>Are employed three sets of programs of different frequencies are modulated specifically for each group of patients in accordance with diagnostic (hepatocellular carcinoma, breast carcinoma and healthy subjects). These frequencies ranging between 0.1 and 114.000Hz.</description>
    <arm_group_label>Healthy patients</arm_group_label>
    <arm_group_label>Oncology patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Healthy volunteers:&#xD;
&#xD;
          -  Should be considered healthy, with no known relevant comorbidity.&#xD;
&#xD;
          -  Patients should not be suffering from active malignancy or history of malignancy in&#xD;
             the past.&#xD;
&#xD;
          -  Must be over 18 years.&#xD;
&#xD;
          -  Must have ability to understand and provide a written informed consent.&#xD;
&#xD;
        Patients with hepatocellular carcinoma:&#xD;
&#xD;
          -  Patients must be diagnosed with inoperable HCC.&#xD;
&#xD;
          -  Presence of primary tumor or metastatic at the time of the procedure.&#xD;
&#xD;
          -  Patients with liver cirrhosis should be restricted to Child-Pugh A or B.&#xD;
&#xD;
          -  Patients with AFP&gt; 400ng/ml and image feature does not require histopathological&#xD;
             confirmation. However, in patients with active serology B virus, this value must be&#xD;
             greater than AFP 4000 ng / ml. The remaining patients should have histological&#xD;
             confirmation of HCC.&#xD;
&#xD;
          -  Patients may be under observation or treatment in the presence of systemic or&#xD;
             intra-hepatic.&#xD;
&#xD;
          -  Must have ability to understand and provide a written informed consent.&#xD;
&#xD;
        Patients with Ductal Carcinoma Breast&#xD;
&#xD;
          -  Patients must have a diagnosis of breast ductal carcinoma inoperable.&#xD;
&#xD;
          -  The presence of the primary tumor or metastatic during the procedure.&#xD;
&#xD;
          -  Patients may be under observation or in the presence of systemic or hormonal treatment&#xD;
             only.&#xD;
&#xD;
          -  Must have ability to understand to provide a written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Can not stop antihypertensive medications or beta-blockers for at least 48 hours or&#xD;
             being in possession of a pacemaker or other implantable device.&#xD;
&#xD;
          -  Pregnant or lactating women.&#xD;
&#xD;
          -  Smaller than 18 years.&#xD;
&#xD;
          -  Patients undergoing radiotherapy treatment or up to 2 weeks of discontinuation.&#xD;
&#xD;
          -  Inability to understand and provide written informed consent.&#xD;
&#xD;
          -  Liver cirrhosis Child Pugh C.&#xD;
&#xD;
          -  Patients without a definite diagnosis.&#xD;
&#xD;
          -  Absence of the primary tumor or metastatic during the procedure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Sírio-Libanês</name>
      <address>
        <city>Sao Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>July 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>September 10, 2015</last_update_submitted>
  <last_update_submitted_qc>September 10, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 14, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Sirio-Libanes</investigator_affiliation>
    <investigator_full_name>Frederico Perego Costa</investigator_full_name>
    <investigator_title>Attending physician</investigator_title>
  </responsible_party>
  <keyword>Breast Cancer</keyword>
  <keyword>Hepatocellular carcinoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01686412
org study id: HSL 2012/10
nct id: NCT01686412
lead sponsor: 
has dmc: Yes
This is an exploratory study, national, unicentric, double-blind, to be conducted at the
      Institute for Teaching and Research of the Hospital Sírio-Libanês in order to detect possible
      autonomic responses resulting from Exposure to Electromagnetic Fields of Low Energy (EEFLE)
      in healthy subjects and in patients with advanced hepatocellular carcinoma or in patients
      with advanced breast carcinoma. Autonomic responses have been described in patients with
      cancer during the exposure of EEFLE. This autonomic response, or biofeedback, due to exposure
      to EEFLE seems to be associated with a specific set of modulation frequencies when applied to
      patients with malignancies. Moreover, healthy individuals exposed to modulated EEFLE a
      specific set of frequency do not appear to autonomic response. Biofeedback is defined by a
      change in amplitude of the radial pulse during exposure to EEFLE, modulated according to a
      set of specific frequencies. This phenomenon is not yet fully elucidated. In exploratory
      survey of one patient was observed a change of the pressure pulse immediately after the start
      of and during exposure to EEFLE, modulated according to a set of specific frequencies
      recorded by digital photoplethysmography. This study aims to evaluate an autonomic response
      in individuals exposed in a single moment, by electromagnetic fields. This study does not
      intend to study a diagnostic or therapeutic procedure. For this reason, evolutive clinical
      data will not be considered during and after the study.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Investigator)
measure: Autonomic response monitoring (blood pressure digital and manual monitoring)
time frame: 60 minutes
measure: Cardiovascular electronic monitoring (digital photoplethysmography and electrocardiography)
time frame: 60 minutes
measure: Baroreflex sensitivity (by the method of sequence)
time frame: 60 minutes
arm group label: Healthy patients
arm group type: Active Comparator
arm group label: Oncology patients
arm group type: Active Comparator
intervention type: Device
intervention name: Electromagnetic Fields of Low Energy (EEFLE)
description: Are employed three sets of programs of different frequencies are modulated specifically for each group of patients in accordance with diagnostic (hepatocellular carcinoma, breast carcinoma and healthy subjects). These frequencies ranging between 0.1 and 114.000Hz.
arm group label: Healthy patients
arm group label: Oncology patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Hospital Sirio-Libanes
investigator full name: Frederico Perego Costa
investigator title: Attending physician
mesh term: Carcinoma, Hepatocellular