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

Early Phase 1

Completed

• Conditions: Cancer; Brain Tumor

• Registration Number: NCT00440570
• Lead Sponsor: Pasche, Boris, M.D.

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.

Study Timeline

• Study Start: 2004-10
• Primary Completion: 2006-09
• Study First Submitted: 2007-02-24
• Study First Submitted QC: 2007-02-26
• Study First Posted: 2007-02-27
• Study Completion: 2007-12
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-28
• Last Update Posted: 2011-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• Advanced tumor that is either metastatic or inoperable

Exclusion Criteria

• Pregnancy,
• Other simultaneous anticancer therapies,
• ECOG performance status less than 3

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety of daily administration of amplitude-modulated electromagnetic fields in patients with advanced cancer

Secondary Outcome Measures

Name	Time	Method
Complete blood count, comprehensive chemistry profile, tumor markers
Tumor assessment as per RECIST criteria

Trial Locations

Locations (1)

Cabinet Médical Avenue de la gare 6; 🇨🇭 Lausanne, Vaud, Switzerland