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

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ClinicalTrials.gov Identifier: NCT00440570
Recruitment Status : Completed
First Posted : February 27, 2007
Last Update Posted : June 29, 2011
Sponsor:
Collaborator:
Barbault, Alexandre, M.S.
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Cancer Brain Tumor Device: Low levels of amplitude-modulated electromagnetic fields Device: Emitter of low levels of amplitude-modulated electromagnetic fields Early Phase 1

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  (Clinical Trial)
Estimated Enrollment : 2 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Treatment of Advanced Cancer With Amplitude-modulated Electromagnetic Fields of Low Intensity by Means of an Intrabuccal Probe
Study Start Date : October 2004
Primary Completion Date : September 2006
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Safety of daily administration of amplitude-modulated electromagnetic fields in patients with advanced cancer

Secondary Outcome Measures :
  1. Complete blood count, comprehensive chemistry profile, tumor markers
  2. Tumor assessment as per RECIST criteria


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Advanced tumor that is either metastatic or inoperable

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00440570


Locations
Switzerland
Cabinet Médical Avenue de la gare 6
Lausanne, Vaud, Switzerland, 1012
Sponsors and Collaborators
Pasche, Boris, M.D.
Barbault, Alexandre, M.S.
Investigators
Principal Investigator: Boris C Pasche, MD, PhD Cabinet Médical Avenue de la gare 6

Publications:
Responsible Party: Boris Pasche
ClinicalTrials.gov Identifier: NCT00440570     History of Changes
Other Study ID Numbers: 001
First Posted: February 27, 2007    Key Record Dates
Last Update Posted: June 29, 2011
Last Verified: June 2011

Keywords provided by Pasche, Boris, M.D.:
cancer
electromagnetic fields
treatment