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Completed

NCT Number: NCT00440570

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

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.

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Key information

Conditions

Cancer Brain Diseases Brain Neoplasms Brain Tumor Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Cabinet Médical Avenue de la gare 6

Lausanne, Canton of Vaud, 1012, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Advanced tumor that is either metastatic or inoperable

Exclusion criteria

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

Treatment and study plan

Low levels of amplitude-modulated electromagnetic fields

Device

Emitter of low levels of amplitude-modulated electromagnetic fields

Device

Primary outcomes

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

Secondary outcomes

  1. Complete blood count, comprehensive chemistry profile, tumor markers

  2. Tumor assessment as per RECIST criteria

Sponsors and collaborators

Lead sponsor

Pasche, Boris, M.D.

Indiv

Collaborators

  • Barbault, Alexandre, M.S.

Registry information

Official study title

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

Acronym: THBC001

Important dates

Study start
2004
Primary completion
2006
Study completion
2007
First posted
Feb 27, 2007
Registry last updated
Jun 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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