Hepatocellular CarcinomaNCT01686412
Determination of Autonomic Responses to Exposure to Electromagnetic Fields With Low Energy Modulated Frequency
A study testing Electromagnetic Fields of Low Energy (EEFLE) in people with Hepatocellular Carcinoma and Breast Cancer, run by Hospital Sirio-Libanes at 1 site in Brazil.
Trial summary
This is an exploratory study, national, unicentric, double-blind, to be conducted at the Institute for Teaching and Research of the Hospital Sírio-Libanês in order to detect possible autonomic responses resulting from Exposure to Electromagnetic Fields of Low Energy (EEFLE) in healthy subjects and in patients with… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma, Breast Cancer
- What is being tested?
- Electromagnetic Fields of Low Energy (EEFLE)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2012to Jun 2015
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers:
- Should be considered healthy, with no known relevant comorbidity.
- Patients should not be suffering from active malignancy or history of malignancy in the past.
- Must be over 18 years.
- Must have ability to understand and provide a written informed consent.
- Patients with hepatocellular carcinoma:
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- Patients must be diagnosed with inoperable HCC.
- Presence of primary tumor or metastatic at the time of the procedure.
- Patients with liver cirrhosis should be restricted to Child-Pugh A or B.
- Patients with AFP> 400ng/ml and image feature does not require histopathological confirmation. However, in patients with active serology B virus, this value must be greater than AFP 4000 ng / ml. The remaining patients should have histological confirmation of HCC.
- Patients may be under observation or treatment in the presence of systemic or intra-hepatic.
- Must have ability to understand and provide a written informed consent.
- Patients with Ductal Carcinoma Breast
- Patients must have a diagnosis of breast ductal carcinoma inoperable.
- The presence of the primary tumor or metastatic during the procedure.
- Patients may be under observation or in the presence of systemic or hormonal treatment only.
- Must have ability to understand to provide a written informed consent.
Who cannot join
- Can not stop antihypertensive medications or beta-blockers for at least 48 hours or being in possession of a pacemaker or other implantable device.
- Pregnant or lactating women.
- Smaller than 18 years.
- Patients undergoing radiotherapy treatment or up to 2 weeks of discontinuation.
- Inability to understand and provide written informed consent.
- Liver cirrhosis Child Pugh C.
- Patients without a definite diagnosis.
- Absence of the primary tumor or metastatic during the procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of Autonomic Responses to Exposure to Electromagnetic Fields With Low Energy Modulated Frequency in Patients With Breast and Advanced Hepatocellular Cancer.
This is an exploratory study, national, unicentric, double-blind, to be conducted at the Institute for Teaching and Research of the Hospital Sírio-Libanês in order to detect possible autonomic responses resulting from Exposure to Electromagnetic Fields of Low Energy (EEFLE) in healthy subjects and in patients with advanced hepatocellular carcinoma or in patients with advanced breast carcinoma. Autonomic responses have been described in patients with cancer during the exposure of EEFLE. This autonomic response, or biofeedback, due to exposure to EEFLE seems to be associated with a specific set of modulation frequencies when applied to patients with malignancies. Moreover, healthy individuals exposed to modulated EEFLE a specific set of frequency do not appear to autonomic response. Biofeedback is defined by a change in amplitude of the radial pulse during exposure to EEFLE, modulated according to a set of specific frequencies. This phenomenon is not yet fully elucidated. In exploratory survey of one patient was observed a change of the pressure pulse immediately after the start of and during exposure to EEFLE, modulated according to a set of specific frequencies recorded by digital photoplethysmography. This study aims to evaluate an autonomic response in individuals exposed in a single moment, by electromagnetic fields. This study does not intend to study a diagnostic or therapeutic procedure. For this reason, evolutive clinical data will not be considered during and after the study.
- Conditions
- Hepatocellular Carcinoma, Breast Cancer
- Being tested
- Electromagnetic Fields of Low Energy (EEFLE)
- Keywords
- Breast Cancer, Hepatocellular carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromagnetic Fields of Low Energy (EEFLE)Device
Are employed three sets of programs of different frequencies are modulated specifically for each group of patients in accordance with diagnostic (hepatocellular carcinoma, breast carcinoma and healthy subjects). These frequencies ranging between 0.1 and 114.000Hz.
| Study group | Role | What they receive |
|---|---|---|
| Healthy patients | Active comparator | Not described Receives: Device: Electromagnetic Fields of Low Energy (EEFLE) |
| Oncology patients | Active comparator | Not described Receives: Device: Electromagnetic Fields of Low Energy (EEFLE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autonomic response monitoring (blood pressure digital and manual monitoring)
Measured: 60 minutes
Secondary outcomes (2)
Cardiovascular electronic monitoring (digital photoplethysmography and electrocardiography)
Measured: 60 minutes
Baroreflex sensitivity (by the method of sequence)
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study startJul 2012
- Primary completionJun 2015
- Study completionJun 2015
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 Hepatocellular CarcinomaStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Sirio-Libanes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frederico Perego Costa, Hospital Sirio-Libanes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686412
- Sponsor's protocol ID
- HSL 2012/10
- Status last verified
- Jun 2015
- First submitted
- 12 Jul 2012
- Last updated
- 14 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Capareli F, Costa F, Tuszynski JA, Sousa MC, Setogute YC, Lima PD, Carvalho L, Santos E, Gumz BP, Sabbaga J, de Castria TB, Jardim DL, Freitas D, Horvat N, Bezerra ROF, Testagrossa L, Costa T, Zanesco T, Iemma AF, Abou-Alfa GK. Low-energy amplitude-modulated electromagnetic field exposure: Feasibility study in patients with hepatocellular carcinoma. Cancer Med. 2023 Jun;12(11):12402-12412. doi: 10.1002/cam4.5944. Epub 2023 May 15.
PubMed 37184216
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Autonomic Responses to Exposure to Electromagnetic Fields With Low Energy Modulated Frequency in Patients With Breast and Advanced Hepatocellular Cancer.
- ClinicalTrials.gov ID
- NCT01686412
- Acronym / sponsor ID
- HSL 2012/10
- Conditions
- Hepatocellular Carcinoma, Breast Cancer
- Keywords
- Breast Cancer, Hepatocellular carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital Sirio-LibanesUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 18 Sep 2012 (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.
This is an exploratory study, national, unicentric, double-blind, to be conducted at the Institute for Teaching and Research of the Hospital Sírio-Libanês in order to detect possible autonomic responses resulting from Exposure to Electromagnetic Fields of Low Energy (EEFLE) in healthy subjects and in patients with advanced hepatocellular carcinoma or in patients with advanced breast carcinoma. Autonomic responses have been described in patients with cancer during the exposure of EEFLE. This autonomic response, or biofeedback, due to exposure to EEFLE seems to be associated with a specific set of modulation frequencies when applied to patients with malignancies. Moreover, healthy individuals exposed to modulated EEFLE a specific set of frequency do not appear to autonomic response. Biofeedback is defined by a change in amplitude of the radial pulse during exposure to EEFLE, modulated according to a set of specific frequencies. This phenomenon is not yet fully elucidated. In exploratory survey of one patient was observed a change of the pressure pulse immediately after the start of and during exposure to EEFLE, modulated according to a set of specific frequencies recorded by digital photoplethysmography. This study aims to evaluate an autonomic response in individuals exposed in a single moment, by electromagnetic fields. This study does not intend to study a diagnostic or therapeutic procedure. For this reason, evolutive clinical data will not be considered during and after the study.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy patients | Active comparator | Device: Electromagnetic Fields of Low Energy (EEFLE) |
| Oncology patients | Active comparator | Device: Electromagnetic Fields of Low Energy (EEFLE) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Should be considered healthy, with no known relevant comorbidity.
- Patients should not be suffering from active malignancy or history of malignancy in the past.
- Must be over 18 years.
- Must have ability to understand and provide a written informed consent.
- Patients must be diagnosed with inoperable HCC.
Key exclusion criteria (8 listed)
- Can not stop antihypertensive medications or beta-blockers for at least 48 hours or being in possession of a pacemaker or other implantable device.
- Pregnant or lactating women.
- Smaller than 18 years.
- Patients undergoing radiotherapy treatment or up to 2 weeks of discontinuation.
- Inability to understand and provide written informed consent.
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 |
|---|---|---|
| Electromagnetic Fields of Low Energy (EEFLE)Are employed three sets of programs of different frequencies are modulated specifically for each group of patients in accordance with diagnostic (hepatocellular carcinoma, breast carcinoma and healthy subjects). These frequencies ranging between 0.1 and 114.000Hz. | Device | Healthy patients, Oncology patients |
Primary outcome
Autonomic response monitoring (blood pressure digital and manual monitoring)
Time frame: 60 minutes
2 secondary outcomes
Cardiovascular electronic monitoring (digital photoplethysmography and electrocardiography)
Time frame: 60 minutes
Baroreflex sensitivity (by the method of sequence)
Time frame: 60 minutes
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 14 Sep 2015.
- Derived from this study: PubMed 37184216Capareli F, Costa F, Tuszynski JA, Sousa MC, Setogute YC, Lima PD, Carvalho L, Santos E, Gumz BP, Sabbaga J, de Castria TB, Jardim DL, Freitas D, Horvat N, Bezerra ROF, Testagrossa L, Costa T, Zanesco T, Iemma AF, Abou-Alfa GK. Low-energy amplitude-modulated electromagnetic field exposure: Feasibility study in patients with hepatocellular carcinoma. Cancer Med. 2023 Jun;12(11):12402-12412. doi: 10.1002/cam4.5944. Epub 2023 May 15.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electromagnetic Fields of Low Energy (EEFLE) in people with Hepatocellular Carcinoma and Breast Cancer, run by Hospital Sirio-Libanes at 1 site in Brazil.
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 17 inclusion and 8 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 14 Sep 2015. 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 Brazil. 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.
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?
Autonomic response monitoring (blood pressure digital and manual monitoring) (time frame: 60 minutes). 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 NCT01686412, 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 14 Sep 2015.