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Phase I/II Study of Amplitude-Modulated Electromagnetic Fields in the Treatment of Advanced Hepatocellular Carcinoma (TheraBionic)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00534664
Recruitment Status : Completed
First Posted : September 26, 2007
Last Update Posted : September 26, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
The goal of this study is to investigate the safety and feasibility of treating patients with advanced hepatocellular carcinoma with a noninvasive device administering low level of amplitude-modulated electromagnetic fields.

Condition or disease Intervention/treatment Phase
Advanced Hepatocellular Carcinoma Device: TheraBionic device Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study to Determine the Effectiveness of Intrabuccally Administered Amplitude-Modulated Electromagnetic Fields in the Treatment of Advanced Hepatocellular Carcinoma
Study Start Date : October 2005
Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Device: TheraBionic device
    Daily outpatient treatment with theraBionic device

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Advanced biopsy-proven HCC
  • Performance status ECOG 0-1
  • Patients with Child Pugh A and B cirrhosis scores
  • Absence of medical or psychiatric contraindication which, in the opinion of the treating investigator, would make the patient's participation in this trial inappropriate.
  • Presence of one or more measurable lesion(s) according to the RECIST criteria.
  • Lesions treated with chemoembolization or ablation by means of radio frequencies will not be considered measurable in this study.
  • Patients on a liver transplant waiting list may be included
  • Patient must not have curative treatment options other than liver transplant
  • Patient may have been treated with intrahepatic treatment (chemoembolization or intrahepatic chemotherapy) or conventional chemotherapy or sorafenib or other experimental therapies prior to study entry. There is no limit for the number of prior therapies
  • Extra hepatic metastases do not constitute an exclusion criterion, except for active CNS metastases.
  • At least 4 weeks must have elapsed since administration of any anti-cancer treatment.
  • Other anti-cancer treatments are not permitted during this study
  • Patients must be more than 18 old and must be able to understand and sign an informed consent.
  • Patient must agree to be followed up according to the study protocol.
  • Patients may have either stable disease or disease progression according to the principal investigator assessment.
  • Patients who carry a pacemaker or any other implantable electronic device are not allowed in the study

Exclusion Criteria:

  • Suspected or biopsy confirmed brain metastases
  • Patients with hepatic cirrhosis with Child-Pugh class C
  • Patients who have received a liver transplant.
  • Patients who had a surgical resection of the disease and who do not have measurable disease.
  • Pregnant women
  • Patients who still show objective response (complete or partial response) according to the RECIST criteria due to the last anti-cancer therapy
  • Patients diagnosed with another type of cancer (excluding basal cell carcinoma) during the last five last years or whose cancer diagnosed previously is not in remission
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00534664


Locations
Brazil
Disciplina de Transplante e Cirurgia do Fígado
São Paulo, Brazil, 05403-000
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Frederico P Costa, MD Disciplina de Transplante e Cirurgia do Fígado
More Information

ClinicalTrials.gov Identifier: NCT00534664     History of Changes
Other Study ID Numbers: THBC-HCC-01
First Posted: September 26, 2007    Key Record Dates
Last Update Posted: September 26, 2007
Last Verified: September 2007

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases