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Identification of Specific Modulation Frequencies in Hepatitis B Carriers With and Without Hepatocellular Carcinoma (THBC-HSL2)

Primary Purpose

Hepatitis, Hepatocellular Carcinomas

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Low intensity amplitude-moduled electromagnetic fields
Sponsored by
Hospital Sirio-Libanes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hepatitis focused on measuring biofeedback response

Eligibility Criteria

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

Inclusion Criteria:

  • hepatitis B carriers patients
  • hepatitis B carriers patients with hepatocellular cancer patients

Exclusion Criteria:

  • other tumor types
  • other hepatitis types

Sites / Locations

  • Hospital Sírio Libanês

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

hepatitis

hepatocellular carcinoma patients

Arm Description

hepatitis B carriers patients

hepatites B carriers patients with associated hepatocellular carcinoma

Outcomes

Primary Outcome Measures

Identification of different group of specific frequencies of modulation in hepatitis B carriers with and without hepatocellular carcinoma associated with biofeedback response
biofeedback response will be monitored

Secondary Outcome Measures

Characterization of differences biofeedback response in hepatitis B carriers with and without hepatocellular carcinoma
Representation of autonomous response during the exposure of specific frequencies of modulation

Full Information

First Posted
July 12, 2012
Last Updated
September 10, 2015
Sponsor
Hospital Sirio-Libanes
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1. Study Identification

Unique Protocol Identification Number
NCT01641276
Brief Title
Identification of Specific Modulation Frequencies in Hepatitis B Carriers With and Without Hepatocellular Carcinoma
Acronym
THBC-HSL2
Official Title
Identification of Specific Modulation Frequencies in Hepatitis B Carriers With and Without Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
April 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
The propose of this study is to identification of a group of specific amplitude-modulated frequencies of low intensity electromagnetic fields that is associated with biofeedback upon exposure to in patients with hepatitis B carries with or without hepatocellular carcinoma.
Detailed Description
Patients will be exposed by different specific amplitude-modulated frequencies of low intensity electromagnetic fields for 30 min. During the exposure, autonomic response with be recorded in order to identify biofeedback response. Differences in group of frequencies is expected in patients with hepatitis B carries with or without hepatocellular carcinoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis, Hepatocellular Carcinomas
Keywords
biofeedback response

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hepatitis
Arm Type
Experimental
Arm Description
hepatitis B carriers patients
Arm Title
hepatocellular carcinoma patients
Arm Type
Experimental
Arm Description
hepatites B carriers patients with associated hepatocellular carcinoma
Intervention Type
Device
Intervention Name(s)
Low intensity amplitude-moduled electromagnetic fields
Other Intervention Name(s)
TheraBionic, OncoBionic P1
Intervention Description
Patients in each arm will be exposed to 30 min of amplitude-moduled low intensity electromagnetic fields only one time.
Primary Outcome Measure Information:
Title
Identification of different group of specific frequencies of modulation in hepatitis B carriers with and without hepatocellular carcinoma associated with biofeedback response
Description
biofeedback response will be monitored
Time Frame
within 10 min of exposure
Secondary Outcome Measure Information:
Title
Characterization of differences biofeedback response in hepatitis B carriers with and without hepatocellular carcinoma
Description
Representation of autonomous response during the exposure of specific frequencies of modulation
Time Frame
within 10 minutes of exposure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: hepatitis B carriers patients hepatitis B carriers patients with hepatocellular cancer patients Exclusion Criteria: other tumor types other hepatitis types
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederico P Costa, MD
Organizational Affiliation
Hospital Sirio-Libanes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Sírio Libanês
City
São Paulo
ZIP/Postal Code
01308-050
Country
Brazil

12. IPD Sharing Statement

Links:
URL
http://www.nature.com/bjc/journal/v105/n5/full/bjc2011292a.html
Description
Results of a phase II study on patients with hepatocellular carcinoma

Learn more about this trial

Identification of Specific Modulation Frequencies in Hepatitis B Carriers With and Without Hepatocellular Carcinoma

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