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

This study is currently recruiting participants.
Verified September 2012 by Hospital Sirio-Libanes
Sponsor:
Information provided by (Responsible Party):
Frederico Perego Costa, Hospital Sirio-Libanes
ClinicalTrials.gov Identifier:
NCT01686412
First received: July 12, 2012
Last updated: October 2, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Hepatocellular Carcinoma
Breast Cancer
Device: Electromagnetic Fields of Low Energy (EEFLE)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Health Services Research
Official Title: Determination of Autonomic Responses to Exposure to Electromagnetic Fields With Low Energy Modulated Frequency in Patients With Breast and Advanced Hepatocellular Cancer.

Resource links provided by NLM:


Further study details as provided by Hospital Sirio-Libanes:

Primary Outcome Measures:
  • Autonomic response monitoring (blood pressure digital and manual monitoring) [ Time Frame: 60 minutes ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cardiovascular electronic monitoring (digital photoplethysmography and electrocardiography) [ Time Frame: 60 minutes ] [ Designated as safety issue: Yes ]
  • Baroreflex sensitivity (by the method of sequence) [ Time Frame: 60 minutes ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: July 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01686412

Contacts
Contact: Frederico Costa +551131558800 frederico.costa@hsl.org.br

Locations
Brazil
Hospital Sírio-Libanês Recruiting
Sao Paulo, Brazil
Contact: Frederico Costa    +551131558800    frederico.costa@hsl.org.br   
Sponsors and Collaborators
Hospital Sirio-Libanes
  More Information

No publications provided

Responsible Party: Frederico Perego Costa, Attending physician, Hospital Sirio-Libanes
ClinicalTrials.gov Identifier: NCT01686412     History of Changes
Other Study ID Numbers: HSL 2012/01
Study First Received: July 12, 2012
Last Updated: October 2, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital Sirio-Libanes:
Breast Cancer
Hepatocellular carcinoma

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Liver Neoplasms
Carcinoma, Hepatocellular
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Digestive System Diseases
Liver Diseases
Adenocarcinoma

ClinicalTrials.gov processed this record on April 17, 2014