A Study of Electromagnetic Waves in the Treatment of the Advanced Hepatocarcinoma (THBC002)
Device: Amplitude-modulated electromagnetic fields
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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|
- • To determine disease free survival at 4 months while receiving the experimental treatment. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Response rate [ Time Frame: six months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||February 2007|
|Study Completion Date:||December 2007|
|Estimated Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00440934
|Cabinet Médical de l'Avenue de la gare 6|
|Lausanne, Vaud, Switzerland, 1003|
|Principal Investigator:||Boris Pasche, MD, PhD||Cabinet Médical Avenue de la gare 6|