CancerEarly Phase 1THBC001NCT00440570
A Study of Therapeutic Amplitude-modulated Electromagnetic Fields in Advanced Tumors
A Early Phase 1 study testing Low levels of amplitude-modulated electromagnetic fields and Emitter of low levels of amplitude-modulated electromagnetic fields in people with Cancer and Brain Tumor, run by Pasche, Boris, M.D. at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer, Brain Tumor
- What is being tested?
- Low levels of amplitude-modulated electromagnetic fields and Emitter of low levels of amplitude-modulated electromagnetic fields
- Type of treatment
- Medical device
- How many people
- 2 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2004to Dec 2007
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Advanced tumor that is either metastatic or inoperable
Who cannot join
- Pregnancy,
- Other simultaneous anticancer therapies,
- ECOG performance status less than 3
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Cabinet Médical Avenue de la gare 6
Lausanne, Canton of Vaud, 1012
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer, Brain Tumor
- Being tested
- Low levels of amplitude-modulated electromagnetic fields, Emitter of low levels of amplitude-modulated electromagnetic fields
- Keywords
- cancer, electromagnetic fields, treatment
- Medical subject headings
- Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low levels of amplitude-modulated electromagnetic fieldsDevice
Emitter of low levels of amplitude-modulated electromagnetic fieldsDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2007 (estimated)
- Study startOct 2004
- Primary completionSep 2006
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants
Sponsor and investigators
- Lead sponsor
- Pasche, Boris, M.D.
- Collaborators
- Barbault, Alexandre, M.S.
- Investigators
- Boris C Pasche, MD, PhD, Principal investigator, Cabinet Médical Avenue de la gare 6
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00440570
- Sponsor's protocol ID
- 001
- Acronym
- THBC001
- Status last verified
- Jun 2011
- First submitted
- 24 Feb 2007
- Last updated
- 29 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19366446
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Advanced Cancer With Amplitude-modulated Electromagnetic Fields of Low Intensity by Means of an Intrabuccal Probe
- ClinicalTrials.gov ID
- NCT00440570
- Acronym / sponsor ID
- THBC001 / 001
- Conditions
- Cancer, Brain Tumor
- Keywords
- cancer, electromagnetic fields, treatment
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants
- Lead sponsor
- Pasche, Boris, M.D.
- Collaborators
- Barbault, Alexandre, M.S.
- Study start
- Oct 2004
- Primary completion
- Sep 2006 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 27 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Advanced tumor that is either metastatic or inoperable
Key exclusion criteria (3 listed)
- Pregnancy,
- Other simultaneous anticancer therapies,
- ECOG performance status less than 3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low levels of amplitude-modulated electromagnetic fields | Device | – |
| Emitter of low levels of amplitude-modulated electromagnetic fields | Device | – |
Primary outcome
Safety of daily administration of amplitude-modulated electromagnetic fields in patients with advanced cancer
2 secondary outcomes
Complete blood count, comprehensive chemistry profile, tumor markers
Tumor assessment as per RECIST criteria
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2011.
- Results publication: PubMed 19366446Barbault 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boris C Pasche, MD, PhD principal investigator
Cabinet Médical Avenue de la gare 6
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Low levels of amplitude-modulated electromagnetic fields and Emitter of low levels of amplitude-modulated electromagnetic fields in people with Cancer and Brain Tumor, run by Pasche, Boris, M.D. at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of daily administration of amplitude-modulated electromagnetic fields in patients with advanced cancer. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00440570, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2011.