NCT01686412

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 18, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

September 14, 2015

Status Verified

June 1, 2015

Enrollment Period

2.9 years

First QC Date

July 12, 2012

Last Update Submit

September 10, 2015

Conditions

Hepatocellular CarcinomaBreast Cancer

Keywords

Breast CancerHepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

  • Autonomic response monitoring (blood pressure digital and manual monitoring)

    60 minutes

Secondary Outcomes (2)

  • Cardiovascular electronic monitoring (digital photoplethysmography and electrocardiography)

    60 minutes

  • Baroreflex sensitivity (by the method of sequence)

    60 minutes

Study Arms (2)

Healthy patients

ACTIVE COMPARATOR
Device: Electromagnetic Fields of Low Energy (EEFLE)

Oncology patients

ACTIVE COMPARATOR
Device: Electromagnetic Fields of Low Energy (EEFLE)

Interventions

Electromagnetic Fields of Low Energy (EEFLE)DEVICE

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.

Healthy patientsOncology patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • +2 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Sírio-Libanês

São Paulo, São Paulo, Brazil

Location

Related Publications (1)

  • Capareli F, Costa F, Tuszynski JA, Sousa MC, Setogute YC, Lima PD, Carvalho L, Santos E, Gumz BP, Sabbaga J, de Castria TB, Jardim DL, Freitas D, Horvat N, Bezerra ROF, Testagrossa L, Costa T, Zanesco T, Iemma AF, Abou-Alfa GK. Low-energy amplitude-modulated electromagnetic field exposure: Feasibility study in patients with hepatocellular carcinoma. Cancer Med. 2023 Jun;12(11):12402-12412. doi: 10.1002/cam4.5944. Epub 2023 May 15.

    PMID: 37184216DERIVED

MeSH Terms

Conditions

Carcinoma, HepatocellularBreast Neoplasms

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

July 12, 2012

First Posted

September 18, 2012

Study Start

July 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

September 14, 2015

Record last verified: 2015-06

Locations

BR(1)