A Study of Therapeutic Amplitude-modulated Electromagnetic Fields in Advanced Tumors (THBC001)

June 28, 2011 updated by: Pasche, Boris, M.D.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

2

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1012
        • Cabinet Médical Avenue de la gare 6

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Advanced tumor that is either metastatic or inoperable

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Complete blood count, comprehensive chemistry profile, tumor markers
Tumor assessment as per RECIST criteria

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pasche, Boris, M.D.

Collaborators

Barbault, Alexandre, M.S.

Investigators

  • Principal Investigator: Boris C Pasche, MD, PhD, Cabinet Médical Avenue de la gare 6

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

February 24, 2007

First Submitted That Met QC Criteria

February 26, 2007

First Posted (Estimate)

February 27, 2007

Study Record Updates

Last Update Posted (Estimate)

June 29, 2011

Last Update Submitted That Met QC Criteria

June 28, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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