NCT00440570

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for early_phase_1 cancer

Timeline
Completed

Started Oct 2004

Typical duration for early_phase_1 cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 27, 2007

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

June 29, 2011

Status Verified

June 1, 2011

Enrollment Period

1.9 years

First QC Date

February 24, 2007

Last Update Submit

June 28, 2011

Conditions

CancerBrain Tumor

Keywords

cancerelectromagnetic fieldstreatment

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

  • Complete blood count, comprehensive chemistry profile, tumor markers

  • Tumor assessment as per RECIST criteria

Interventions

Low levels of amplitude-modulated electromagnetic fieldsDEVICE
Emitter of low levels of amplitude-modulated electromagnetic fieldsDEVICE

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Advanced tumor that is either metastatic or inoperable

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cabinet Médical Avenue de la gare 6

Lausanne, Canton of Vaud, 1012, Switzerland

Location

Related 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 Res. 2009 Apr 14;28(1):51. doi: 10.1186/1756-9966-28-51.

    PMID: 19366446RESULT

MeSH Terms

Conditions

NeoplasmsBrain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Boris C Pasche, MD, PhD

    Cabinet Médical Avenue de la gare 6

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV

Study Record Dates

First Submitted

February 24, 2007

First Posted

February 27, 2007

Study Start

October 1, 2004

Primary Completion

September 1, 2006

Study Completion

December 1, 2007

Last Updated

June 29, 2011

Record last verified: 2011-06

Locations

CH(1)