BIOTHERAPY WITH THE PINEAL IMMUNOMODULATING HORMONE MELATONIN VERSUS MELATONIN PLUS ALOE-VERA IN UNTREATABLE ADVANCED SOLID NEOPLASMS

The possibility of natural cancer therapy has been recently suggested by advances in the knowledge of tumor immunobiology. Either cytokines such as IL-2, or neurohormones, such as the pineal indole melatonin (M LT), may activate anticancer immunity. In addition, immunomodulating s ubstances have also been isolated from plants, particularly from Aloe vera. Preliminary clinical studies had already shown that MLT may indu ce some benefits in untreatable metastatic solid tumor patients, where as, for the time being, no clinical trial has been performed with aloe products. We have carried out a clinical study to evaluate whether th e concomitant administration of aloe may enhance the therapeutic resul ts of MLT in patients with advanced solid tumors for whom no effective standard anticancer therapies are available. The study included 50 pa tients suffering from lung cancer, gastrointestinal tract tumors, brea st cancer or brain glioblastoma, who were treated with MLT alone (20 m g/day orally in the dark period) or MLT plus A. vera tincture (1 mi tw ice/day). A partial response (PR) was achieved in 2/24 patients treate d with MLT plus aloe and in none of the patients treated with MLT alon e. Stable disease (SD) was achieved in 12/24 and in 7/26 patients trea ted with MLT plus aloe or MLT alone, respectively. Therefore, the perc entage of nonprogressing patients (PR + SD) was significantly higher i n the group treated with MLT plus aloe than in the MLT group(14/24 vs. 7/26, p < 0.05). The percent 1-year survival was significantly higher in patients treated with MLT plus aloe (9/24 vs. 4/26, p < 0.05). Bot h treatments were well tolerated. This preliminary study would suggest that natural cancer therapy with MLT plus A. vera extracts may produc e some therapeutic benefits, at least in terms of stabilization of dis ease and survival, in patients with advanced solid tumors, for whom no other standard effective therapy is available.