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This is an exploratory study, national, unicentric, double-blind, to be conducted at the Institute for Teaching and Research of the Hospital SÃrio-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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy patients | Active Comparator |
| |
| Oncology patients | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Autonomic response monitoring (blood pressure digital and manual monitoring) | 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular electronic monitoring (digital photoplethysmography and electrocardiography) | 60 minutes | |
| Baroreflex sensitivity (by the method of sequence) | 60 minutes |
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Inclusion Criteria:
Healthy volunteers:
Patients with hepatocellular carcinoma:
Patients with Ductal Carcinoma Breast
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital SÃrio-Libanês | São Paulo | São Paulo | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37184216 | Derived | 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. |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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|
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |