A Preliminary Phase-2 Study with very High-Dose of Melatonin (1000 mg/day) in Untreatable Advanced Cancer Patients Already Progression on Previous Palliative Therapy with High-Dose Melatonin

It is known since more than 50 years that the pineal gland plays a fundamental role in the natural biological resistance against cancer onset and growth. The anticancer role of the pineal gland is due to the production of several antitumor molecules, the most known of them is the indole hormone melatonin (MLT). Unfortunately, although there are a lot of experimental evidences that MLT is completely non-toxic, no oncologist seem to be interested to the clinical use of MLT in the treatment of human neoplasms, at least from a palliative point of view. However, a few number of clinical studies of MLT in the complementary treatment of cancer has demonstrated that the anticancer activity of MLT is a dose-dependent phenomenon. On this basis, a preliminary study with a very high dose of MLT, consisting of 1000 mg/once day in the evening, was carried out in untreatable cancer patients, who failed to respond to the conventional anticancer therapies, and for whom the only available treatment was the palliative therapy. The treatment was well tolerated, and a disease control was achieved in 54% patients. These preliminary results would justify further clinical studies to generate a new interpretation of cancer control, consisting of the pharmacological reproduction of the same mechanisms responsible for the natural resistance against cancer development.