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| Sponsors and Collaborators: |
Pasche, Boris, M.D. Barbault, Alexandre, M.S. |
|---|---|
| Information provided by: | Pasche, Boris, M.D. |
| ClinicalTrials.gov Identifier: | NCT00440570 |
Purpose
In vitro studies suggest that low levels of amplitude-modulated electromagnetic fields may modify cell growth. We have identified specific frequencies that may block cancer cell growth. We have developed a device delivering low levels of amplitude-modulated electromagnetic fields. The device is connected to a spoon-like coupler, which is placed in the patient's mouth during treatment. We will conduct a phase I study consisting of three daily 40 min ambulatory treatments until disease progression.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer Brain Tumor |
Device: Low levels of amplitud-modulated electromagnetic fields Device: Emitter of low levels of amplitude-modulated electromagnetic fields |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Official Title: | Treatment of Advanced Cancer With Amplitude-Modulated Electromagnetic Fields of Low Intensity by Means of an Intrabuccal Probe |
| Estimated Enrollment: | 25 |
| Study Start Date: | October 2004 |
| Estimated Study Completion Date: | March 2005 |
| Estimated Primary Completion Date: | March 2005 (Final data collection date for primary outcome measure) |
Background: In vitro studies suggest that low levels of amplitude-modulated electromagnetic fields may modify cell growth. We have identified specific frequencies that may block cancer cell growth. We have developed a portable and programmable device delivering low levels of amplitude-modulated electromagnetic fields. The device is connected to a spoon-like coupler, which is placed in the patient's mouth during treatment.
Methods: We will conducted a phase I study consisting of three daily 40 min treatments. All patients with advanced solid tumors and measurable disease will be eligible, irrespective of prior treatments. Patients will be assessed with laboratory exams (complete blood count, comprehensive profile, tumor markers), imaging studies every other month for the first six months, every third month thereafter.
Eligibility| Ages Eligible for Study: | 18 Years to 95 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Switzerland, Vaud | |
| Cabinet Médical Avenue de la gare 6 | |
| Lausanne, Vaud, Switzerland, 1012 | |
| Principal Investigator: | Boris C Pasche, MD, PhD | Cabinet Médical Avenue de la gare 6 |
More Information
| Responsible Party: | Boris Pasche ( Boris Pasche ) |
| Study ID Numbers: | 001 |
| Study First Received: | February 24, 2007 |
| Last Updated: | April 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00440570 |
| Health Authority: | Switzerland: Laws and standards |
|
cancer electromagnetic fields treatment |
|
Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Brain Diseases Nervous System Neoplasms |
|
Neoplasms Neoplasms by Site Nervous System Diseases |
