Back to results

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

Primary Purpose

Hepatocellular Carcinoma, Breast Cancer

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Electromagnetic Fields of Low Energy (EEFLE)

About this trial

This is an interventional health services research trial for Hepatocellular Carcinoma focused on measuring Breast Cancer, Hepatocellular carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Hospital Sírio-Libanês

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Healthy patients

Oncology patients

Arm Description

Outcomes

Primary Outcome Measures

Autonomic response monitoring (blood pressure digital and manual monitoring)

Secondary Outcome Measures

Cardiovascular electronic monitoring (digital photoplethysmography and electrocardiography)

Baroreflex sensitivity (by the method of sequence)

Full Information

NCT ID

NCT01686412

First Posted

July 12, 2012

Last Updated

September 10, 2015

Sponsor

Hospital Sirio-Libanes

1. Study Identification

Unique Protocol Identification Number

NCT01686412

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

July 2012 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Sirio-Libanes

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma, Breast Cancer

Keywords

Breast Cancer, Hepatocellular carcinoma

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Non-Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Healthy patients

Arm Type

Active Comparator

Arm Title

Oncology patients

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

Electromagnetic Fields of Low Energy (EEFLE)

Intervention 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.

Primary Outcome Measure Information:

Title

Autonomic response monitoring (blood pressure digital and manual monitoring)

Time Frame

60 minutes

Secondary Outcome Measure Information:

Title

Cardiovascular electronic monitoring (digital photoplethysmography and electrocardiography)

Time Frame

60 minutes

Title

Baroreflex sensitivity (by the method of sequence)

Time Frame

60 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Hospital Sírio-Libanês

City

Sao Paulo

Country

Brazil

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs