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

This study has been terminated.
(Poor patient accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00440934
First Posted: February 27, 2007
Last Update Posted: May 6, 2008
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.
Collaborator:
Barbault, Alexandre, M.S.
Information provided by:
Pasche, Boris, M.D.
  Purpose
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.

Condition Intervention Phase
Carcinoma, Hepatocellular Device: Amplitude-modulated electromagnetic fields Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pasche, Boris, M.D.:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: February 2007
Study Completion Date: December 2007
Estimated Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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): NCT00440934


Locations
Switzerland
Cabinet Médical de l'Avenue de la gare 6
Lausanne, Vaud, Switzerland, 1003
Sponsors and Collaborators
Pasche, Boris, M.D.
Barbault, Alexandre, M.S.
Investigators
Principal Investigator: Boris Pasche, MD, PhD Cabinet Médical Avenue de la gare 6
  More Information

Responsible Party: Boris Pasche
ClinicalTrials.gov Identifier: NCT00440934     History of Changes
Other Study ID Numbers: THBC 002
First Submitted: February 24, 2007
First Posted: February 27, 2007
Last Update Posted: May 6, 2008
Last Verified: May 2008

Keywords provided by Pasche, Boris, M.D.:
carcinoma, hepatocellular
electromagnetic fields

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