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NCT03448757
Determination of Autonomic Responses to the Exposure of Low Energy Electromagnetic Fields With Frequency Modulation in Patients With Advanced Hepatocellular Carcinoma and Healthy Individuals.
NA trial testing measuring hemodynamic parameters heart beat to heart beat during single-frequency exposure in Hepatocellular Carcinoma in 60 participants. Status unknown.
15 August 2021
Quick facts
| Lead sponsor | Hospital Sirio-Libanes |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 15 February 2018 |
| Primary completion | 15 August 2021 |
| Estimated completion | 16 December 2023 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- measuring hemodynamic parameters heart beat to heart beat during single-frequency exposure
Conditions studied
- Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →
Sponsor
Hospital Sirio-Libanes
Who can join
Adults 18 to 80, any sex, with Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03448757
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Hospital Sirio-Libanes trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03448757 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital Sirio-Libanes
- Last refreshed: 22 November 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03448757.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing