A Study of Electromagnetic Waves in the Treatment of the Advanced Hepatocarcinoma (THBC002)

May 2, 2008 updated by: Pasche, Boris, M.D.

Étude de Phase II Pour déterminer l'efficacité Des Ondes électromagnétiques de Basse intensité administrées Par Voie Buccale Dans le Traitement du Cancer du Foie avancé

Hepatocarcinoma (HCC) is the first cause of deaths due to cancer worldwide. More than one million two hundred thousand new patients are diagnosed each year. The prognosis of patients suffering from advanced hepatocarcinoma is poor with an average survival of less than six months. Phase I data suggest that low levels of electromagnetic fields administered intrabucally with a portable and programmable device are a safe and potentially effective treatment for advanced cancer. The device is connected to a spoon-like coupler placed in the patient's mouth during treatment. Patients with advanced HCC and limited therapeutic options will be offered treatment with a combination of frequencies.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Hepatocarcinoma (HCC) is the first cause of deaths due to cancer worldwide. More than one million two hundred thousand new patients are diagnosed each year. The prognosis of patients suffering from advanced hepatocarcinoma is poor with an average survival of less than six months. Therapies for hepatocarcinoma are limited. Resection of the primary tumor is the therapeutic approach of first choice when possible. Although this intervention results in long-term survival for some patients, only a minority of them are surgical candidates because of limitations due to tumor size, patient's overall condition or presence of hepatic cirrhosis.

Phase I data suggest that low levels of amplitude-modulated electromagnetic fields administered intrabucally with a portable and programmable device are a safe and potentially effective treatment for advanced cancer. The device is connected to a spoon-like coupler placed in the patient's mouth during treatment. Patients with advanced HCC and limited therapeutic options will be offered treatment with a combination of HCC-specific frequencies.

The patients will be offered ambulatory treatment, which will be administered three times a day for 60 min until disease progression or death.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1003
        • Cabinet Médical de l'Avenue de la gare 6

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patients must have a diagnosis of inoperable hepatocellular carcinoma.
  • The patients who have an AFP level higher than 400 ng/ml and an appearance characteristic of cancer of the liver do not need histological confirmation. These patients must however have a negative serology for the antigen of surface of hepatitis B If serology for this antigen is positive, they must have a rate of AFP higher than 4000 ng/ml.
  • Presence of one or more lesions measurable(s) according to criteria's RECIST.

Exclusion Criteria:

  • Other anti-cancer treatments are not authorized during this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
• To determine disease free survival at 4 months while receiving the experimental treatment.
Time Frame: 4 months
4 months
Response rate
Time Frame: six months
six months

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the influence of the treatment on the hepatic function of patients with a diagnosis of cirrhosis. To determine the impact of the treatment by means of electromagnetic waves on the overall survival of patients.
Time Frame: six months
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pasche, Boris, M.D.

Collaborators

Barbault, Alexandre, M.S.

Investigators

  • Principal Investigator: Boris Pasche, MD, PhD, Cabinet Médical Avenue de la gare 6

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (ANTICIPATED)

December 1, 2007

Study Completion (ACTUAL)

December 1, 2007

Study Registration Dates

First Submitted

February 24, 2007

First Submitted That Met QC Criteria

February 26, 2007

First Posted (ESTIMATE)

February 27, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

May 6, 2008

Last Update Submitted That Met QC Criteria

May 2, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THBC 002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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