Determination of Autonomic Responses to Exposure to Electromagnetic Fields With Low Energy Modulated Frequency

September 10, 2015 updated by: Frederico Perego Costa, Hospital Sirio-Libanes

Determination of Autonomic Responses to Exposure to Electromagnetic Fields With Low Energy Modulated Frequency in Patients With Breast and Advanced Hepatocellular Cancer.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil
        • Hospital Sírio-Libanês

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Healthy volunteers:

  • Should be considered healthy, with no known relevant comorbidity.
  • Patients should not be suffering from active malignancy or history of malignancy in the past.
  • Must be over 18 years.
  • Must have ability to understand and provide a written informed consent.

Patients with hepatocellular carcinoma:

  • Patients must be diagnosed with inoperable HCC.
  • Presence of primary tumor or metastatic at the time of the procedure.
  • Patients with liver cirrhosis should be restricted to Child-Pugh A or B.
  • Patients with AFP> 400ng/ml and image feature does not require histopathological confirmation. However, in patients with active serology B virus, this value must be greater than AFP 4000 ng / ml. The remaining patients should have histological confirmation of HCC.
  • Patients may be under observation or treatment in the presence of systemic or intra-hepatic.
  • Must have ability to understand and provide a written informed consent.

Patients with Ductal Carcinoma Breast

  • Patients must have a diagnosis of breast ductal carcinoma inoperable.
  • The presence of the primary tumor or metastatic during the procedure.
  • Patients may be under observation or in the presence of systemic or hormonal treatment only.
  • Must have ability to understand to provide a written informed consent.

Exclusion Criteria:

  • Can not stop antihypertensive medications or beta-blockers for at least 48 hours or being in possession of a pacemaker or other implantable device.
  • Pregnant or lactating women.
  • Smaller than 18 years.
  • Patients undergoing radiotherapy treatment or up to 2 weeks of discontinuation.
  • Inability to understand and provide written informed consent.
  • Liver cirrhosis Child Pugh C.
  • Patients without a definite diagnosis.
  • Absence of the primary tumor or metastatic during the procedure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Healthy patients
Device: Electromagnetic Fields of Low Energy (EEFLE)
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.
Active Comparator: Oncology patients
Device: Electromagnetic Fields of Low Energy (EEFLE)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Autonomic response monitoring (blood pressure digital and manual monitoring)
Time Frame: 60 minutes
60 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Cardiovascular electronic monitoring (digital photoplethysmography and electrocardiography)
Time Frame: 60 minutes
60 minutes
Baroreflex sensitivity (by the method of sequence)
Time Frame: 60 minutes
60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Sirio-Libanes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

July 12, 2012

First Submitted That Met QC Criteria

September 12, 2012

First Posted (Estimate)

September 18, 2012

Study Record Updates

Last Update Posted (Estimate)

September 14, 2015

Last Update Submitted That Met QC Criteria

September 10, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSL 2012/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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