title: Safety, tolerability, and effect on quality of life of a mixture of amino acids and other small molecules in cancer patients.
abstract: 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.
authors: 1 Cancer Research and Drug Development Center, Culevit Ltd. , Pécs, Hungary .
authors: Tamás
authors: T
authors: Czömpöly
authors: Zoltán
authors: Z
authors: Langmár
authors: Mária
authors: M
authors: Bors
authors: Csilla
authors: C
authors: Zsákai
authors: Mária
authors: M
authors: Géczy
authors: Gyula
authors: G
authors: Kulcsár
mesh_terms: D000328:Adult; D000368:Aged; D000596:Amino Acids / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy* / Q000523:psychology; D011788:Quality of Life; D014815:Vitamins / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000596:Amino Acids; D014815:Vitamins