Clinical trial NCT00805337: Low Levels of Electromagnetic Fields to Treat Advanced Cancer
Official title: Compassionate Treatment of Advanced Cancer With Amplitude-Modulated Electromagnetic Fields
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Cancer
Keywords: Cancer amplitude-modulated electromagnetic fields
Lead sponsor: Pasche, Boris, M.D.
Sponsor class: INDIV
First posted: 2008-12-09
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT

Brief summary: Following the discovery of tumor-specific frequencies in patients with advanced cancer, compassionate treatment with tumor-specific frequencies administered at levels that are significantly below the levels generated by cell phone will be offered to patients with limited therapeutic options.

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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of cancer with advanced disease and limited therapeutic options

Exclusion Criteria:

* Any patient with curative treatment options

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References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Amato D, Pasche B. An evaluation of the safety of low energy emission therapy. Compr Ther. 1993;19(5):242-7. No abstract available.
citation: 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.