A Study of Therapeutic Amplitude-modulated Electromagnetic Fields in Advanced Tumors

Study Overview
=================
Brief Summary
-----------------
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 feasibility study consisting of three daily ambulatory treatments until disease progression.

Detailed Description
-----------------
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 feasibility study consisting of three daily 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.

Official Title
-----------------
Treatment of Advanced Cancer With Amplitude-modulated Electromagnetic Fields of Low Intensity by Means of an Intrabuccal Probe

Conditions
-----------------
Cancer, Brain Tumor

Intervention / Treatment
-----------------
* Device: Low levels of amplitude-modulated electromagnetic fields
* Device: Emitter of low levels of amplitude-modulated electromagnetic fields


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced tumor that is either metastatic or inoperable Exclusion Criteria: Pregnancy, Other simultaneous anticancer therapies, ECOG performance status less than 3

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Low levels of amplitude-modulated electromagnetic fields|nan|
|Device: Emitter of low levels of amplitude-modulated electromagnetic fields|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of daily administration of amplitude-modulated electromagnetic fields in patients with advanced cancer |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete blood count, comprehensive chemistry profile, tumor markers |  |  | 
| Tumor assessment as per RECIST criteria |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, electromagnetic fields, treatment