Results of a toxicity pilot human study approved by the competent ethical Committee are reported. Eleven patients with heavily pre-treated advanced cancer were enrolled in a pilot study with different schedules of time exposure to static magnetic fields (MF), amplitude modulated by ELF. An area including the neck, thoracic and abdomen was MF exposed daily, 5 days/week for 4 weeks according to two different schedules: 20 min daily (4 patients) and 70 min daily (7 patients). ECOG performance status was 1 (2 patients), 2 (8 patients), 3 (1 patient). Toxicity was assessed according to WHO criteria. ECG, Chest X-ray, physical examination, blood cell count and complete blood chemistry were performed before and at the end of the treatment. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) elevation (grade 2 toxicity) in 1 patient and microscopic urinary abnormalities in 5 patients were the only negative effects observed. We conclude that MF can be safely administrated according to the MF exposure schedules.
2004 Wiley-Liss, Inc.