RF Safe

Treatment of advanced hepatocellular carcinoma with very low levels of amplitude-modulated electromagnetic fields

Br J Cancer · 2011 · Benefit · Low evidence

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BenefitLow evidencePaper 6738

In a single-group open-label phase I/II study (n=41), intrabuccal amplitude-modulated electromagnetic field treatment was reported as well tolerated with no NCI grade 2–4 toxicities. Fourteen patients (34.1%) had stable disease for >6 months; median progressi…

Study snapshot

PublicationBr J Cancer · 2011
Study typeother
Reported directionBenefit
Evidence ratingLow

Abstract

Background: Therapeutic options for patients with advanced hepatocellular carcinoma (HCC) are limited. There is emerging evidence that the growth of cancer cells may be altered by very low levels of electromagnetic fields modulated at specific frequencies. Methods: A single-group, open-label, phase I/II study was performed to assess the safety and effectiveness of the intrabuccal administration of very low levels of electromagnetic fields amplitude modulated at HCC-specific frequencies in 41 patients with advanced HCC and limited therapeutic options. Three-daily 60-min outpatient treatments were administered until disease progression or death. Imaging studies were performed every 8 weeks. The primary efficacy end point was progression-free survival 6 months. Secondary efficacy end points were progression-free survival and overall survival. Results: Treatment was well tolerated and there were no NCI grade 2, 3 or 4 toxicities. In all, 14 patients (34.1%) had stable disease for more than 6 months. Median progression-free survival was 4.4 months (95% CI 2.1-5.3) and median overall survival was 6.7 months (95% CI 3.0-10.2). There were three partial and one near complete responses. Conclusion: Treatment with intrabuccally administered amplitude-modulated electromagnetic fields is safe, well tolerated, and shows evidence of antitumour effects in patients with advanced HCC.

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 directionbenefit
PopulationPatients with advanced hepatocellular carcinoma (HCC) and limited therapeutic options
Sample size41
ExposureThree-daily 60-min outpatient treatments administered until disease progression or death
Evidence strengthLowConfidence: 74% · Peer reviewed: yes

Main findings

In a single-group open-label phase I/II study (n=41), intrabuccal amplitude-modulated electromagnetic field treatment was reported as well tolerated with no NCI grade 2–4 toxicities. Fourteen patients (34.1%) had stable disease for >6 months; median progression-free survival was 4.4 months and median overall survival was 6.7 months, with three partial and one near complete responses reported.

Outcomes measured

  • Safety/toxicity (NCI grade 2–4 toxicities)
  • Progression-free survival ≥6 months (primary endpoint)
  • Progression-free survival (median)
  • Overall survival (median)
  • Tumor response (stable disease, partial response, near complete response)

Limitations

  • Single-group, open-label design (no control group described)
  • Specific EMF parameters (e.g., carrier frequency, field strength, modulation details) not provided in abstract
View raw extracted JSON
{
  "study_type": "other",
  "exposure": {
    "band": null,
    "source": "intrabuccal administration of amplitude-modulated electromagnetic fields",
    "frequency_mhz": null,
    "sar_wkg": null,
    "duration": "Three-daily 60-min outpatient treatments administered until disease progression or death"
  },
  "population": "Patients with advanced hepatocellular carcinoma (HCC) and limited therapeutic options",
  "sample_size": 41,
  "outcomes": [
    "Safety/toxicity (NCI grade 2–4 toxicities)",
    "Progression-free survival ≥6 months (primary endpoint)",
    "Progression-free survival (median)",
    "Overall survival (median)",
    "Tumor response (stable disease, partial response, near complete response)"
  ],
  "main_findings": "In a single-group open-label phase I/II study (n=41), intrabuccal amplitude-modulated electromagnetic field treatment was reported as well tolerated with no NCI grade 2–4 toxicities. Fourteen patients (34.1%) had stable disease for >6 months; median progression-free survival was 4.4 months and median overall survival was 6.7 months, with three partial and one near complete responses reported.",
  "effect_direction": "benefit",
  "limitations": [
    "Single-group, open-label design (no control group described)",
    "Specific EMF parameters (e.g., carrier frequency, field strength, modulation details) not provided in abstract"
  ],
  "evidence_strength": "low",
  "confidence": 0.74,
  "peer_reviewed_likely": "yes",
  "keywords": [
    "hepatocellular carcinoma",
    "HCC",
    "amplitude-modulated electromagnetic fields",
    "intrabuccal administration",
    "phase I/II",
    "progression-free survival",
    "overall survival",
    "tumor response",
    "safety",
    "toxicity"
  ],
  "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: 10.1038/bjc.2011.292
PubMed: 21829195

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