A Study of Electromagnetic Waves in the Treatment of the Advanced Hepatocarcinoma (THBC002)
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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 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 ]
| 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) |
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| Ages Eligible for Study: | 18 Years to 95 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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| Switzerland | |
| 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 |
More Information
No publications provided
| Responsible Party: | Boris Pasche |
| ClinicalTrials.gov Identifier: | NCT00440934 History of Changes |
| Other Study ID Numbers: | THBC 002 |
| Study First Received: | February 24, 2007 |
| Last Updated: | May 2, 2008 |
| Health Authority: | Switzerland: Laws and standards |
Keywords provided by Pasche, Boris, M.D.:
|
carcinoma, hepatocellular electromagnetic fields |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |
ClinicalTrials.gov processed this record on June 17, 2013