Hepatocellular CarcinomaNCT03448757
Determination of Autonomic Responses to the Exposure of Low Energy Electromagnetic Fields With Frequency Modulation in Patients With Advanced Hepatocellular Carcinoma and Healthy Individuals.
A study testing measuring hemodynamic parameters heart beat to heart beat during single-frequency exposure in people with Hepatocellular Carcinoma, run by Hospital Sirio-Libanes at 1 site in Brazil.
Trial summary
Biofeedback is an autonomic response observed during the exposure period to CEMBE. After prospectively evaluating 20 healthy individuals or 40 patients with advanced breast cancer or hepatocarcinoma, it was possible to determine subtle hemodynamic changes consistent with the biofeedback effect associated with exposure… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- measuring hemodynamic parameters heart beat to heart beat during single-frequency exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Feb 2018to 16 Dec 2023
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
- Must be considered healthy, with no known relevant comorbidity.
- Patients must not be carriers of active malignant neoplasm or have a history of malignant neoplasm.
- Must be over 18 years old.
- Must have the ability to understand and provide written Informed Consent.
- Patients with hepatocellular carcinoma
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- Patients must be diagnosed with inoperable HCC.
- Presence of the primary or metastatic tumor at the time of the procedure.
- Patients diagnosed with hepatic cirrhosis must be restricted to Child-Pugh A or B.
- Patients with AFP> 400 ng/ml and characteristic image do not need histopathological confirmation. However, in patients with serology for active B virus, this AFP value must be greater than 4000 ng/ml. The remaining patients must have histological confirmation of HCC.
- Patients may be in observation or in the course of systemic or intra-hepatic treatment.
- Must have the ability to understand and provide written Informed Consent.
Who cannot join
- Individuals selected for this study will be excluded if they meet the following exclusion criteria:
- They cannot stop antihypertensive drugs or beta blockers for at least 24 hours.
- Have a pacemaker or other implantable device.
- Pregnant or breastfeeding.
- Under the age of 18.
- Patients undergoing radiotherapy or up to 2 weeks after its suspension.
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- Inability to understand and provide written Informed Consent.
- Child Pugh C hepatic cirrhosis.
- Patient without definite diagnosis.
- Absence of primary or metastatic tumor at the time of the procedure.
- Potentially eligible participants will be previously guided by the researcher on the objectives and risks of the study in question and will be presented and informed about the Free, Prior and Informed Consent document.
- Only after all doubts related to the study have been clarified and the Free, Prior and Informed Consent document has been signed, will the study participant be invited and scheduled to attend the Oncology Center clinic of Hospital Sírio Libanês.
- Patients must be informed that they may not drink alcohol up to 12 hours before the procedure, as there may be interference during the procedure.
- They will also be advised not to use antihypertensive drugs like beta-blockers or calcium channel inhibitors 24 hours before the procedure, without resulting in a risk to the participant's health.
- In this study, following or follow-up of patients is not foreseen.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Sírio-Libanês
São Paulo
Tatiana Zanesco, 5511983539222, tzanesco@hotmail.com
About this study
Biofeedback is an autonomic response observed during the exposure period to CEMBE. After prospectively evaluating 20 healthy individuals or 40 patients with advanced breast cancer or hepatocarcinoma, it was possible to determine subtle hemodynamic changes consistent with the biofeedback effect associated with exposure to a cancer-specific set of modulated frequencies.
Once CEMBE is administered through an intra-oral administration device, the human body absorbs the energy applied at the level of 0.2-1 mW / kg, with a peak absorption in 10 g of tissue between 55 and 132 mW / kg. Initially, the discriminatory study analyzing 9 hemodynamic parameters recorded beat heart beat in 18 individuals demonstrated a hemodynamic pattern specific for hepatocarcinoma and breast cancer, with sensitivity of 94.1% and 95%, respectively, and specificity of 75% and 95%, respectively. These findings were validated in blind analysis in the remaining 56 patients, confirming the high rate of discriminatory success.
Read more
A specific pattern of response associated with exposure of a cancer-specific frequency group was also observed in patients diagnosed with neoplasia, since the control group of healthy individuals did not present these response patterns.
This specific signature of response to CEMBE-modulated exposure to cancer-specific frequencies was significantly altered only in patients with hepatocarcinoma after tumor withdrawal (Costa et al, 2015a).
Read the detailed description
This is an exploratory, national, unicentric, open study, to be conducted at the Instituto de Ensino e Pesquisa do Hospital Sírio Libanês, aiming to determine a method of prospective measurement of autonomic responses resulting from exposure to LEEF modulated at specific frequencies and with sequential exposure (frequency to frequency) in healthy individuals and patients with advanced hepatocellular carcinoma , followed by new exposure with a new set of specific frequencies determined by mathematical method.
This study aims to create a method for non-invasive diagnosis of biofeedback effect exposure to LEEF modulated to specific frequencies in individuals exposed to hepatocellular carcinoma -specific frequencies in increasing sequential manner, frequency to frequency in patients with advanced hepatocellular carcinoma and healthy individuals.
Patients with advanced hepatocellular carcinoma will be exposed to specific LEEF-modulated frequencies (3 to 10 Hz difference) to identify the optimal frequency associated with greater response to the biofeedback effect in patients with advanced hepatocellular carcinoma.
Patients with advanced hepatocellular carcinoma will be exposed to modulated LEEF at a new set of specific frequencies determined by mathematical method to identify biofeedback effect in patients with advanced hepatocellular carcinoma.
This study does not propose to study a therapeutic procedure. For this reason, no evolutionary clinical data will be analyzed during and after study intervention.
This study will be conducted in an outpatient setting and is expected to last 24 months.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- measuring hemodynamic parameters heart beat to heart beat during single-frequency exposure
- Keywords
- LEEF, hemodynamic parameters, heart beat, biofeedback effect
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measuring hemodynamic parameters heart beat to heart beat during single-frequency exposureOther
This study aims to create a method for non-invasive diagnosis of biofeedback effect exposure to LEEF modulated to specific frequencies in individuals exposed to hepatocellular carcinoma -specific frequencies in increasing sequential manner, frequency to frequency in patients with advanced hepatocellular carcinoma and healthy individuals.
Patients with advanced hepatocellular carcinoma will be exposed to specific LEEF-modulated frequencies (3 to 10 Hz difference) to identify the optimal frequency associated with greater response to the biofeedback effect in patients with advanced hepatocellular carcinoma.
| Study group | Role | What they receive |
|---|---|---|
| Autonomic response | Experimental | Group for determination of biofeedback response - 40 individuals. For the formation of this study group of subjects, 20 healthy volunteers and 20 patients with advanced hepatocellular carcinoma will be selected and studied.
Group for determination of ideal frequency - 20 patients. For the formation of this study group of subjects, 20 patients with advanced hepatocellular carcinoma participants in the group will be selected and studied to determine biofeedback response.
Group for determination of new specific frequencies - 20 individuals. For the formation of this study group of subjects, 20 patients with advanced hepatocellular carcinoma not exposed to any specific frequency will be selected. Receives: Other: measuring hemodynamic parameters heart beat to heart beat during single-frequency exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
non-invasive hemodynamic parameter measurements during exposure AM RF EMF
Identification of hemodymanic alterations induced by the exposure to low levels of amplitude modulation radiofrequency electromagnetic fields (AM RF EMF) in healthy individuals and patients with advanced hepatocellular carcinoma using Artificial Intelligence program to analyze the recorded data set collected by a high-precision and non-invasive hemodynamic monitor.
Measured: 90 min on day 1 and day 2
Secondary outcomes (1)
Hemodynamic alteration´s comparison among advanced cancer patients and healthy controls
Comparison of hemodynamic alteration during exposure to a group of hepatocellular-specific AM RF EMF recorded in healthy individuals and patients with advanced hepatocellular carcinoma using Artificial Intelligence algorithms to compare the recorded data set collected by a high-precision and non-invasive hemodynamic monitor.
Measured: 120 min (single procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start15 Feb 2018
- Primary completion15 Aug 2021
- Study completion16 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- measuring hemodynamic parameters heart beat to heart beat during single-frequency exposure
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
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
- NCT03448757
- Sponsor's protocol ID
- HSL 2016-83
- Status last verified
- Nov 2023
- First submitted
- 20 Feb 2018
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no sharing plan.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Autonomic Responses to the Exposure of Low Energy Electromagnetic Fields With Frequency Modulation in Patients With Advanced Hepatocellular Carcinoma and Healthy Individuals.
- ClinicalTrials.gov ID
- NCT03448757
- Acronym / sponsor ID
- HSL 2016-83
- Conditions
- Hepatocellular Carcinoma
- Keywords
- LEEF, hemodynamic parameters, heart beat, biofeedback effect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Sirio-LibanesUniversity, hospital or other
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 16 Dec 2023 (estimated)
- First posted
- 28 Feb 2018 (actual)
- 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.
Biofeedback is an autonomic response observed during the exposure period to CEMBE. After prospectively evaluating 20 healthy individuals or 40 patients with advanced breast cancer or hepatocarcinoma, it was possible to determine subtle hemodynamic changes consistent with the biofeedback effect associated with exposure to a cancer-specific set of modulated frequencies.
Once CEMBE is administered through an intra-oral administration device, the human body absorbs the energy applied at the level of 0.2-1 mW / kg, with a peak absorption in 10 g of tissue between 55 and 132 mW / kg. Initially, the discriminatory study analyzing 9 hemodynamic parameters recorded beat heart beat in 18 individuals demonstrated a hemodynamic pattern specific for hepatocarcinoma and breast cancer, with sensitivity of 94.1% and 95%, respectively, and specificity of 75% and 95%, respectively. These findings were validated in blind analysis in the remaining 56 patients, confirming the high rate of discriminatory success.
A specific pattern of response associated with exposure of a cancer-specific frequency group was also observed in patients diagnosed with neoplasia, since the control group of healthy individuals did not present these response patterns.
This specific signature of response to CEMBE-modulated exposure to cancer-specific frequencies was significantly altered only in patients with hepatocarcinoma after tumor withdrawal (Costa et al, 2015a).
Detailed description
This is an exploratory, national, unicentric, open study, to be conducted at the Instituto de Ensino e Pesquisa do Hospital Sírio Libanês, aiming to determine a method of prospective measurement of autonomic responses resulting from exposure to LEEF modulated at specific frequencies and with sequential exposure (frequency to frequency) in healthy individuals and patients with advanced hepatocellular carcinoma , followed by new exposure with a new set of specific frequencies determined by mathematical method.
This study aims to create a method for non-invasive diagnosis of biofeedback effect exposure to LEEF modulated to specific frequencies in individuals exposed to hepatocellular carcinoma -specific frequencies in increasing sequential manner, frequency to frequency in patients with advanced hepatocellular carcinoma and healthy individuals.
Patients with advanced hepatocellular carcinoma will be exposed to specific LEEF-modulated frequencies (3 to 10 Hz difference) to identify the optimal frequency associated with greater response to the biofeedback effect in patients with advanced hepatocellular carcinoma.
Patients with advanced hepatocellular carcinoma will be exposed to modulated LEEF at a new set of specific frequencies determined by mathematical method to identify biofeedback effect in patients with advanced hepatocellular carcinoma.
This study does not propose to study a therapeutic procedure. For this reason, no evolutionary clinical data will be analyzed during and after study intervention.
This study will be conducted in an outpatient setting and is expected to last 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- measuring hemodynamic parameters heart beat to heart beat during single-frequency exposure
| Arm | Type | Receives |
|---|---|---|
| Autonomic response | Experimental | Other: measuring hemodynamic parameters heart beat to heart beat during single-frequency exposureGroup for determination of biofeedback response - 40 individuals. For the formation of this study group of subjects, 20 healthy volunteers and 20 patients with advanced hepatocellular carcinoma will be selected and studied. Group for determination of ideal frequency - 20 patients. For the formation of this study group of subjects, 20 patients with advanced hepatocellular carcinoma participants in the group will be selected and studied to determine biofeedback response. Group for determination of new specific frequencies - 20 individuals. For the formation of this study group of subjects, 20 patients with advanced hepatocellular carcinoma not exposed to any specific frequency will be selected. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Healthy volunteers
- Patients with hepatocellular carcinoma
- Patients must be diagnosed with inoperable HCC.
- Presence of the primary or metastatic tumor at the time of the procedure.
- Patients diagnosed with hepatic cirrhosis must be restricted to Child-Pugh A or B.
Key exclusion criteria (15 listed)
- Individuals selected for this study will be excluded if they meet the following exclusion criteria:
- Potentially eligible participants will be previously guided by the researcher on the objectives and risks of the study in question and will be presented and informed about the Free, Prior and Informed Consent document.
- Only after all doubts related to the study have been clarified and the Free, Prior and Informed Consent document has been signed, will the study participant be invited and scheduled to attend the Oncology Center clinic of Hospital Sírio Libanês.
- Patients must be informed that they may not drink alcohol up to 12 hours before the procedure, as there may be interference during the procedure.
- They will also be advised not to use antihypertensive drugs like beta-blockers or calcium channel inhibitors 24 hours before the procedure, without resulting in a risk to the participant's health.
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 |
|---|---|---|
| measuring hemodynamic parameters heart beat to heart beat during single-frequency exposureThis study aims to create a method for non-invasive diagnosis of biofeedback effect exposure to LEEF modulated to specific frequencies in individuals exposed to hepatocellular carcinoma -specific frequencies in increasing sequential manner, frequency to frequency in patients with advanced hepatocellular carcinoma and healthy individuals. Patients with advanced hepatocellular carcinoma will be exposed to specific LEEF-modulated frequencies (3 to 10 Hz difference) to identify the optimal frequency associated with greater response to the biofeedback effect in patients with advanced hepatocellular carcinoma. | Other | Autonomic response |
Primary outcome
non-invasive hemodynamic parameter measurements during exposure AM RF EMF
Time frame: 90 min on day 1 and day 2
Identification of hemodymanic alterations induced by the exposure to low levels of amplitude modulation radiofrequency electromagnetic fields (AM RF EMF) in healthy individuals and patients with advanced hepatocellular carcinoma using Artificial Intelligence program to analyze the recorded data set collected by a high-precision and non-invasive hemodynamic monitor.
1 secondary outcome
Hemodynamic alteration´s comparison among advanced cancer patients and healthy controls
Time frame: 120 min (single procedure)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: No. There is no sharing plan.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing measuring hemodynamic parameters heart beat to heart beat during single-frequency exposure in people with Hepatocellular Carcinoma, 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 12 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 22 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frederico Costa, MD (5511996737593, fredericoperegocosta@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
non-invasive hemodynamic parameter measurements during exposure AM RF EMF (time frame: 90 min on day 1 and day 2). 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 22 Nov 2023.