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

PAPER pubmed Cancer medicine 2023 Other Effect: mixed Evidence: Low

Read original paper → DOI: 10.1002/cam4.5944 PMID: 37184216 Evidence Lab

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.

AI evidence extraction

At a glance

Study type

Other

Effect direction

mixed

Population

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

Sample size

Exposure

medical device (AutEMdev; amplitude-modulated EMF exposure) · 90-min procedures every 2–4 weeks

Evidence strength

Low

Confidence: 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": 0.7399999999999999911182158029987476766109466552734375,
    "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/metadata and may be incomplete or incorrect. This content is for informational purposes only and is not medical advice.

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