A Study of Electromagnetic Waves in the Treatment of the Advanced Hepatocarcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Carcinoma, Hepatocellular

Keywords

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carcinoma, hepatocellular electromagnetic fields

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Amplitude-modulated electromagnetic fields

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Boris Pasche

Principal Investigators

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Boris Pasche, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cabinet Médical Avenue de la gare 6

Locations

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Cabinet Médical de l'Avenue de la gare 6

Lausanne, Canton of Vaud, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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THBC 002

Identifier Type: -

Identifier Source: org_study_id