Low-energy amplitude-modulated electromagnetic field exposure: Feasibility study in patients with hepatocellular carcinoma.

Cancer medicine · 2023 · Mixed · Low evidence

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MixedLow evidencePaper 5796

Study snapshot

PublicationCancer medicine · 2023

Study typeother

Reported directionMixed

Evidence ratingLow

Abstract

BACKGROUND: Patients with advanced hepatocellular carcinoma (HCC) and poor liver function lack effective systemic therapies. Low-energy electromagnetic fields (EMFs) can influence cell biological processes via non-thermal effects and may represent a new treatment option. METHODS: This single-site feasibility trial enrolled patients with advanced HCC, Child-Pugh A and B, Eastern Cooperative Oncology Group 0-2. Patients underwent 90-min amplitude-modulated EMF exposure procedures every 2-4 weeks, using the AutEMdev (Autem Therapeutics). Patients could also receive standard care. The primary endpoints were safety and the identification of hemodynamic variability patterns. Exploratory endpoints included health-related quality of life (HRQoL), overall survival (OS). and objective response rate (ORR) using RECIST v1.1. RESULTS: Sixty-six patients with advanced HCC received 539 AutEMdev procedures (median follow-up, 30 months). No serious adverse events occurred during procedures. Self-limiting grade 1 somnolence occurred in 78.7% of patients. Hemodynamic variability during EMF exposure was associated with specific amplitude-modulation frequencies. HRQoL was maintained or improved among patients remaining on treatment. Median OS was 11.3 months (95% confidence interval [CI]: 6.0, 16.6) overall (16.0 months [95% CI: 4.4, 27.6] and 12.0 months [6.4, 17.6] for combination therapy and monotherapy, respectively). ORR was 24.3% (32% and 17% for combination therapy and monotherapy, respectively). CONCLUSION: AutEMdev EMF exposure has an excellent safety profile in patients with advanced HCC. Hemodynamic alterations at personalized frequencies may represent a surrogate of anti-tumor efficacy. NCT01686412.

Machine Enhanced Logic

AI evidence extraction

Structured fields below were generated from the paper’s abstract and metadata to make the evidence easier to inspect. Automated extraction may be incomplete or incorrect; verify important details against the original paper.

Study typeother

Effect directionmixed

PopulationPatients with advanced hepatocellular carcinoma (Child-Pugh A and B; ECOG 0–2)

Sample size66

Exposure90-min procedures every 2–4 weeks

Evidence strengthLowConfidence: 74% · Peer reviewed: yes

Main findings

In 66 patients receiving 539 procedures (median follow-up 30 months), no serious adverse events occurred during procedures; self-limiting grade 1 somnolence occurred in 78.7% of patients. Hemodynamic variability during exposure was associated with specific amplitude-modulation frequencies. HRQoL was maintained or improved among patients remaining on treatment; median OS was 11.3 months overall and ORR was 24.3%.

Outcomes measured

Safety (adverse events during procedures)
Hemodynamic variability patterns during EMF exposure
Health-related quality of life (HRQoL)
Overall survival (OS)
Objective response rate (ORR) by RECIST v1.1

Limitations

Single-site feasibility trial
Patients could also receive standard care (combination therapy vs monotherapy reported)
Exploratory endpoints (HRQoL, OS, ORR)

View raw extracted JSON

{
  "study_type": "other",
  "exposure": {
    "band": null,
    "source": "medical device (AutEMdev; amplitude-modulated EMF exposure)",
    "frequency_mhz": null,
    "sar_wkg": null,
    "duration": "90-min procedures every 2–4 weeks"
  },
  "population": "Patients with advanced hepatocellular carcinoma (Child-Pugh A and B; ECOG 0–2)",
  "sample_size": 66,
  "outcomes": [
    "Safety (adverse events during procedures)",
    "Hemodynamic variability patterns during EMF exposure",
    "Health-related quality of life (HRQoL)",
    "Overall survival (OS)",
    "Objective response rate (ORR) by RECIST v1.1"
  ],
  "main_findings": "In 66 patients receiving 539 procedures (median follow-up 30 months), no serious adverse events occurred during procedures; self-limiting grade 1 somnolence occurred in 78.7% of patients. Hemodynamic variability during exposure was associated with specific amplitude-modulation frequencies. HRQoL was maintained or improved among patients remaining on treatment; median OS was 11.3 months overall and ORR was 24.3%.",
  "effect_direction": "mixed",
  "limitations": [
    "Single-site feasibility trial",
    "Patients could also receive standard care (combination therapy vs monotherapy reported)",
    "Exploratory endpoints (HRQoL, OS, ORR)"
  ],
  "evidence_strength": "low",
  "confidence": 0.74,
  "peer_reviewed_likely": "yes",
  "keywords": [
    "amplitude-modulated electromagnetic field",
    "low-energy EMF",
    "AutEMdev",
    "Autem Therapeutics",
    "hepatocellular carcinoma",
    "feasibility trial",
    "safety",
    "hemodynamic variability",
    "quality of life",
    "overall survival",
    "objective response rate",
    "RECIST v1.1"
  ],
  "suggested_hubs": []
}

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AI-extracted fields are generated from the abstract and metadata and may be incomplete or incorrect. This material is for informational purposes and is not medical advice.

Identifiers and source

DOI: 10.1002/cam4.5944
PubMed: 37184216

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