NCT01686412

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Hospital Sirio-Libanes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Hepatocellular Carcinoma
• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-07-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2012-09-18
• Last updated: 2015-09-14

Locations

1 site across 1 country: Brazil