Exploring how low energy electromagnetic fields affect patients with advanced liver cancer and healthy individuals
Determination of Autonomic Responses to the Exposure of Low Energy Electromagnetic Fields With Frequency Modulation in Patients With Advanced Hepatocellular Carcinoma and Healthy Individuals.
This study is testing how low energy electromagnetic fields affect people with advanced liver cancer and healthy individuals to see if it can change their heart responses and overall well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Hospital Sirio-Libanes Academic / other |
| Locations | 1 site (São Paulo) |
| Trial ID | NCT03448757 on ClinicalTrials.gov |
What this trial studies
This study investigates the autonomic responses of patients with advanced hepatocellular carcinoma and healthy individuals when exposed to low energy electromagnetic fields (LEEF) modulated at specific frequencies. It aims to measure hemodynamic changes and identify a biofeedback effect associated with these exposures. The study will involve sequential exposure to different frequencies to determine the optimal response in patients with liver cancer. The methodology includes non-invasive measurements of heart rate and other parameters to assess the effects of LEEF.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with inoperable hepatocellular carcinoma or healthy individuals without any known comorbidities.
Not a fit: Patients with active malignant neoplasms other than hepatocellular carcinoma or those with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a novel non-invasive diagnostic method for detecting biofeedback effects in patients with advanced liver cancer.
How similar studies have performed: While the approach of using LEEF for diagnostic purposes is relatively novel, similar studies have shown promising results in measuring autonomic responses in other conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * 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. Exclusion Criteria: * 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. * 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.
Where this trial is running
São Paulo
- Hospital Sírio-Libanês — São Paulo, Brazil (Recruiting)
Study contacts
- Study coordinator: Frederico Costa, MD
- Email: fredericoperegocosta@gmail.com
- Phone: 5511996737593
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.