RESUMO
We performed two clinical studies to evaluate the safety, tolerability, and effect on quality of life of a product containing a mixture of amino acids, vitamins, and other small molecules. In the first one period, open-label, multiple-dose study, the safety and tolerability of a 1-week administration was evaluated in 24 healthy volunteers. In the second one period, open-label, multiple-dose, single-arm study, we investigated the safety, tolerability, and effect on quality of life of a 4-week administration in 50 cancer patients. The safety assessment included the monitoring of adverse events, changes in physical status, and clinical laboratory tests. Changes in quality of life were measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 version 3.0 (EORTC QLQ-C30). We have found that administration of the investigated product is safe and well tolerated in healthy individuals and in cancer patients. Administration of the product to cancer patients significantly improved their quality of life (EORTC QLQ-C30 global health status score: baseline: 24.17 ± 9.2; end of treatment: 47.08 ± 14.56, p<0.001). To evaluate the anticancer activity of the investigated product in humans, a randomized, blinded, combination clinical trial should be conducted.
