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

Hepatitis Clinical Trial

— THBC-HSL2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01641276
• Other study ID #: 02621512.3.0000.5461
• Status: Completed
• Phase: N/A
• First received: July 12, 2012
• Last updated: September 10, 2015
• Start date: April 2012
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Hospital Sirio-Libanes
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• hepatitis B carriers patients

• hepatitis B carriers patients with hepatocellular cancer patients

Exclusion Criteria:

• other tumor types

• other hepatitis types

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatitis
• Hepatitis A
• Hepatocellular Carcinomas

Intervention

Device:
• Low intensity amplitude-moduled electromagnetic fields
Patients in each arm will be exposed to 30 min of amplitude-moduled low intensity electromagnetic fields only one time.

Locations

Country	Name	City	State
Brazil	Hospital Sírio Libanês	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Sirio-Libanes

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	within 10 min of exposure	Yes
Secondary	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	within 10 minutes of exposure	Yes

External Links

•   Results of a phase II study on patients with hepatocellular carcinoma