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

Cancer Clinical Trial

— THBC001  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00440570
• Other study ID #: 001
• Status: Completed
• Phase: Phase 0
• First received: February 24, 2007
• Last updated: June 28, 2011
• Start date: October 2004
• Est. completion date: December 2007

Study information

• Verified date: June 2011
• Source: Pasche, Boris, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Laws and standards
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: December 2007
• Est. primary completion date: September 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Brain Tumor
• Cancer

Intervention

Device:
• Low levels of amplitude-modulated electromagnetic fields

• Emitter of low levels of amplitude-modulated electromagnetic fields

Locations

Country	Name	City	State
Switzerland	Cabinet Médical Avenue de la gare 6	Lausanne	Vaud

Sponsors (2)

Lead Sponsor	Collaborator
Pasche, Boris, M.D.	Barbault, Alexandre, M.S.

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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 Re — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of daily administration of amplitude-modulated electromagnetic fields in patients with advanced cancer
Secondary	Complete blood count, comprehensive chemistry profile, tumor markers
Secondary	Tumor assessment as per RECIST criteria