A Study of Therapeutic Amplitude-modulated Electromagneti... | NCT00440570

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

NCT00440570

Sponsor

Pasche, Boris, M.D.

Status

Completed

Last Update Posted

Jun 29, 2011Estimated

Enrollment

Phase

Early Phase 1

Conditions

Cancer
Brain Tumor

Interventions

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

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2004

Primary Completion Date

Sep 2006Actual

Completion Date

Dec 2007Actual

First Submitted Date

Feb 24, 2007

First Submission Date that Met QC Criteria

Feb 26, 2007

First Posted Date

Feb 27, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 28, 2011

Last Update Posted Date

Jun 29, 2011Estimated

Name	Class
Barbault, Alexandre, M.S.	INDIV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Low levels of amplitude-modulated electromagnetic fields	Device
Emitter of low levels of amplitude-modulated electromagnetic fields	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety of daily administration of amplitude-modulated electromagnetic fields in patients with advanced cancer

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Advanced tumor that is either metastatic or inoperable

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Boris C Pasche, MD, PhD	Cabinet Médical Avenue de la gare 6	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cabinet Médical Avenue de la gare 6		Lausanne	Canton of Vaud	1012	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19366446	Result	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.

ID	Term
D009369	Neoplasms
D001932	Brain Neoplasms

ID	Term
D016543	Central Nervous System Neoplasms
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D001927	Brain Diseases