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

NCT ID: NCT00440570

Last Updated: 2011-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2007-12-31

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.

Conditions

Cancer; Brain Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Interventions

Low levels of amplitude-modulated electromagnetic fields

Intervention Type: DEVICE

Emitter of low levels of amplitude-modulated electromagnetic fields

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Barbault, Alexandre, M.S.

INDIV

Sponsor Role: collaborator

Pasche, Boris, M.D.

INDIV

Sponsor Role: lead

Responsible Party

Boris Pasche

Principal Investigators

Boris C Pasche, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cabinet Médical Avenue de la gare 6

Locations

Cabinet Médical Avenue de la gare 6

Lausanne, Canton of Vaud, Switzerland

Countries

Switzerland

References

Barbault A, Costa FP, Bottger B, Munden RF, Bomholt F, Kuster N, Pasche B. Amplitude-modulated electromagnetic fields for the treatment of cancer: discovery of tumor-specific frequencies and assessment of a novel therapeutic approach. J Exp Clin Cancer Res. 2009 Apr 14;28(1):51. doi: 10.1186/1756-9966-28-51.

Reference Type: RESULT

PMID: 19366446 (View on PubMed)

Other Identifiers

001

Identifier Type: -

Identifier Source: org_study_id