Carcinoma, HepatocellularPhase 2THBC002NCT00440934
A Study of Electromagnetic Waves in the Treatment of the Advanced Hepatocarcinoma
A Phase 2 study testing Amplitude-modulated electromagnetic fields in people with Carcinoma, Hepatocellular, run by Pasche, Boris, M.D. at 1 site in Switzerland.
Trial summary
Hepatocarcinoma (HCC) is the first cause of deaths due to cancer worldwide. More than one million two hundred thousand new patients are diagnosed each year. The prognosis of patients suffering from advanced hepatocarcinoma is poor with an average survival of less than six months. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- Amplitude-modulated electromagnetic fields
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2007to Dec 2007
- Phase
- Phase 2
- 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
- The patients must have a diagnosis of inoperable hepatocellular carcinoma.
- The patients who have an AFP level higher than 400 ng/ml and an appearance characteristic of cancer of the liver do not need histological confirmation. These patients must however have a negative serology for the antigen of surface of hepatitis B If serology for this antigen is positive, they must have a rate of AFP higher than 4000 ng/ml.
- Presence of one or more lesions measurable(s) according to criteria's RECIST.
Who cannot join
- Other anti-cancer treatments are not authorized during this study.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Cabinet Médical de l'Avenue de la gare 6
Lausanne, Canton of Vaud, 1003
About this study
Official title: Étude de Phase II Pour déterminer l'efficacité Des Ondes électromagnétiques de Basse intensité administrées Par Voie Buccale Dans le Traitement du Cancer du Foie avancé
Hepatocarcinoma (HCC) is the first cause of deaths due to cancer worldwide. More than one million two hundred thousand new patients are diagnosed each year. The prognosis of patients suffering from advanced hepatocarcinoma is poor with an average survival of less than six months. Phase I data suggest that low levels of electromagnetic fields administered intrabucally with a portable and programmable device are a safe and potentially effective treatment for advanced cancer. The device is connected to a spoon-like coupler placed in the patient's mouth during treatment. Patients with advanced HCC and limited therapeutic options will be offered treatment with a combination of frequencies.
Read the detailed description
Hepatocarcinoma (HCC) is the first cause of deaths due to cancer worldwide. More than one million two hundred thousand new patients are diagnosed each year. The prognosis of patients suffering from advanced hepatocarcinoma is poor with an average survival of less than six months. Therapies for hepatocarcinoma are limited. Resection of the primary tumor is the therapeutic approach of first choice when possible. Although this intervention results in long-term survival for some patients, only a minority of them are surgical candidates because of limitations due to tumor size, patient's overall condition or presence of hepatic cirrhosis.
Phase I data suggest that low levels of amplitude-modulated electromagnetic fields administered intrabucally with a portable and programmable device are a safe and potentially effective treatment for advanced cancer. The device is connected to a spoon-like coupler placed in the patient's mouth during treatment. Patients with advanced HCC and limited therapeutic options will be offered treatment with a combination of HCC-specific frequencies.
The patients will be offered ambulatory treatment, which will be administered three times a day for 60 min until disease progression or death.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- Amplitude-modulated electromagnetic fields
- Keywords
- carcinoma, hepatocellular, electromagnetic fields
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amplitude-modulated electromagnetic fieldsDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
• To determine disease free survival at 4 months while receiving the experimental treatment.
Measured: 4 months
Response rate
Measured: six months
Secondary outcomes (1)
To determine the influence of the treatment on the hepatic function of patients with a diagnosis of cirrhosis. To determine the impact of the treatment by means of electromagnetic waves on the overall survival of patients.
Measured: six months
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 startFeb 2007
- Primary completionDec 2007 (estimated)
- Study completionDec 2007
Why it stopped: Poor patient accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pasche, Boris, M.D.
- Collaborators
- Barbault, Alexandre, M.S.
- Investigators
- Boris Pasche, MD, PhD, Principal investigator, Cabinet Médical Avenue de la gare 6
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00440934
- Sponsor's protocol ID
- THBC 002
- Acronym
- THBC002
- Status last verified
- May 2008
- First submitted
- 24 Feb 2007
- Last updated
- 6 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Étude de Phase II Pour déterminer l'efficacité Des Ondes électromagnétiques de Basse intensité administrées Par Voie Buccale Dans le Traitement du Cancer du Foie avancé
- ClinicalTrials.gov ID
- NCT00440934
- Acronym / sponsor ID
- THBC002 / THBC 002
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- carcinoma, hepatocellular, electromagnetic fields
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor patient accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pasche, Boris, M.D.
- Collaborators
- Barbault, Alexandre, M.S.
- Study start
- Feb 2007
- Primary completion
- Dec 2007 (estimated)
- 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.
Hepatocarcinoma (HCC) is the first cause of deaths due to cancer worldwide. More than one million two hundred thousand new patients are diagnosed each year. The prognosis of patients suffering from advanced hepatocarcinoma is poor with an average survival of less than six months. Phase I data suggest that low levels of electromagnetic fields administered intrabucally with a portable and programmable device are a safe and potentially effective treatment for advanced cancer. The device is connected to a spoon-like coupler placed in the patient's mouth during treatment. Patients with advanced HCC and limited therapeutic options will be offered treatment with a combination of frequencies.
Detailed description
Hepatocarcinoma (HCC) is the first cause of deaths due to cancer worldwide. More than one million two hundred thousand new patients are diagnosed each year. The prognosis of patients suffering from advanced hepatocarcinoma is poor with an average survival of less than six months. Therapies for hepatocarcinoma are limited. Resection of the primary tumor is the therapeutic approach of first choice when possible. Although this intervention results in long-term survival for some patients, only a minority of them are surgical candidates because of limitations due to tumor size, patient's overall condition or presence of hepatic cirrhosis.
Phase I data suggest that low levels of amplitude-modulated electromagnetic fields administered intrabucally with a portable and programmable device are a safe and potentially effective treatment for advanced cancer. The device is connected to a spoon-like coupler placed in the patient's mouth during treatment. Patients with advanced HCC and limited therapeutic options will be offered treatment with a combination of HCC-specific frequencies.
The patients will be offered ambulatory treatment, which will be administered three times a day for 60 min until disease progression or death.
Study design
- Primary purpose
- Treatment
- 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 (3 listed)
- The patients must have a diagnosis of inoperable hepatocellular carcinoma.
- The patients who have an AFP level higher than 400 ng/ml and an appearance characteristic of cancer of the liver do not need histological confirmation. These patients must however have a negative serology for the antigen of surface of hepatitis B If serology for this antigen is positive, they must have a rate of AFP higher than 4000 ng/ml.
- Presence of one or more lesions measurable(s) according to criteria's RECIST.
Key exclusion criteria (1 listed)
- Other anti-cancer treatments are not authorized during this study.
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 |
|---|---|---|
| Amplitude-modulated electromagnetic fields | Device | – |
Primary outcome
• To determine disease free survival at 4 months while receiving the experimental treatment.
Time frame: 4 months
Response rate
Time frame: six months
1 secondary outcome
To determine the influence of the treatment on the hepatic function of patients with a diagnosis of cirrhosis. To determine the impact of the treatment by means of electromagnetic waves on the overall survival of patients.
Time frame: six months
Results and safety
The study was stopped early (reason given: Poor patient accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2008.
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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 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 Phase 2 study testing Amplitude-modulated electromagnetic fields in people with Carcinoma, Hepatocellular, 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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 6 May 2008. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Poor patient accrual). Results are not available in the source record.
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?
• To determine disease free survival at 4 months while receiving the experimental treatment. (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2008.