Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00440934
Status:
TERMINATED
Last Update Posted:
2008-05-06
First Post:
2007-02-24
Brief Title:
A Study of Electromagnetic Waves in the Treatment of the Advanced Hepatocarcinoma
Sponsor:
Pasche Boris MD
Organization:
Pasche Boris MD
Study Overview
Official Title:
Étude de Phase II Pour déterminer lefficacité Des Ondes électromagnétiques de Basse intensité administrées Par Voie Buccale Dans le Traitement du Cancer du Foie avancé
Status:
TERMINATED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor patient accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
THBC002
Brief Summary:
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 patients mouth during treatment Patients with advanced HCC and limited therapeutic options will be offered treatment with a combination of frequencies
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 patients 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 patients 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None