- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00805337
Low Levels of Electromagnetic Fields to Treat Advanced Cancer (ADLG3)
Compassionate Treatment of Advanced Cancer With Amplitude-Modulated Electromagnetic Fields
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
We have previously shown that the intrabuccal administration of low and safe levels of electromagnetic fields, amplitude-modulated at a frequency of 42.7 Hz by means of a battery-powered portable device modifies the electroencephalographic activity of healthy subjects (1, 2) and is associated with subjective and objective relaxation effects (3). These results prompted us to study the effects of the 42.7 Hz frequency in patients suffering from insomnia. A randomized control trial did not reveal any difference between 42.7 Hz treatment and placebo (4) but sequential administration of four insomnia-specific frequencies, including 42.7 Hz, resulted in a significant decrease in sleep latency and a significant increase in total sleep time in patients suffering from chronic insomnia (5). Dosimetric studies have shown that the amount of electromagnetic fields delivered to the brain of patients with this approach is 100 to 1000 times lower than the amount of electromagnetic fields delivered by handheld cellular phones and do not result in any heating effect within the brain (4). The U.S. FDA has determined that such a device is not a significant risk device. Lastly, a long-term follow-up survey of 807 patients who have received this therapy revealed that the rate of adverse reactions were low and were not associated with increases in the incidence of malignancy or coronary heart disease (6).
Given the advantageous safety profile of athermal, non-ionizing radiofrequency electromagnetic fields and the emerging evidence that low levels of electromagnetic or electric fields may modify the growth of tumor cells (7-9), we decided to test the hypothesis that low levels of electromagnetic fields modulated at tumor-specific frequencies may alter the growth of human malignancies. We have developed a novel patient-based biofeedback method with the goal to identify cancer-specific frequencies and have examined patients with this approach. Following identification of such frequencies in a total of 163 patients, we will offer compassionate treatment to 28 patients with advanced cancer and limited palliative therapeutic options.
Study Type
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of cancer with advanced disease and limited therapeutic options
Exclusion Criteria:
- Any patient with curative treatment options
Study Plan
How is the study designed?
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Kelly TL, Kripke DF, Hayduk R, Ryman D, Pasche B, Barbault A. Bright light and LEET effects on circadian rhythms, sleep and cognitive performance. Stress Med. 1997 Oct;13(4):251-8. doi: 10.1002/(SICI)1099-1700(199710)13:43.0.CO;2-0.
- Pasche B, Erman M, Hayduk R, Mitler MM, Reite M, Higgs L, Kuster N, Rossel C, Dafni U, Amato D, Barbault A, Lebet JP. Effects of low energy emission therapy in chronic psychophysiological insomnia. Sleep. 1996 May;19(4):327-36. doi: 10.1093/sleep/19.4.327.
- Lebet JP, Barbault A, Rossel C, Tomic Z, Reite M, Higgs L, Dafni U, Amato D, Pasche B. Electroencephalographic changes following low energy emission therapy. Ann Biomed Eng. 1996 May-Jun;24(3):424-9. doi: 10.1007/BF02660891.
- Reite M, Higgs L, Lebet JP, Barbault A, Rossel C, Kuster N, Dafni U, Amato D, Pasche B. Sleep inducing effect of low energy emission therapy. Bioelectromagnetics. 1994;15(1):67-75. doi: 10.1002/bem.2250150110.
- Amato D, Pasche B. An evaluation of the safety of low energy emission therapy. Compr Ther. 1993;19(5):242-7. No abstract available. Erratum In: Compr Ther 1994;20(12):681.
- Barbault A, Costa FP, Bottger B, Munden RF, Bomholt F, Kuster N, Pasche B. Amplitude-modulated electromagnetic fields for the treatment of cancer: discovery of tumor-specific frequencies and assessment of a novel therapeutic approach. J Exp Clin Cancer Res. 2009 Apr 14;28(1):51. doi: 10.1186/1756-9966-28-51.
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ADLG3
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