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. 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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• To determine disease free survival at 4 months while receiving the experimental treatment.
4 months
No
Boris Pasche, MD, PhD
Principal Investigator
Cabinet Médical Avenue de la gare 6
Switzerland: Laws and standards
THBC 002
NCT00440934
February 2007
December 2007
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