Open phase II study on efficacy and safety of an oral amino acid functional cluster supplementation in cancer cachexia

The aim of the present study was to test the efficacy and safety of an oral amino acid functional cluster (AFC) supplementation in cachectic cancer patients. From April 2008 to March 2009, we carried out an open non-randomized phase II study on 25 cachectic advanced (all stage IV) cancer patients with tumor at different sites who received an oral AFC supplementation for 8 weeks. Efficacy was assessed on the basis of improvement of some nutritional/functional (weight, body mass index, lean body mass and grip strength), quality of life (fatigue) and laboratory (albumin, fibrinogen, C-reactive protein, proinflammatory cytokines, leptin and reactive oxygen species) variables. Safety was evaluated according to the NCI-CTCAE version 3. Patients supplemented with the AFC achieved an increase in grip strength (P < 0.0001) and total serum albumin (P = 0.0003) and a decrease in ROS levels (P = 0.001). Moreover, our study showed a trend toward an increase in body weight and leptin and a decrease in CRP and IL-6. In conclusion, the results of the present study suggest that amino acid supplementation may be a significant rational tool for the treatment of cancer cachexia. Our preliminary data should be confirmed in a larger sample size and by a properly designed randomized clinical trial. According to our longstanding experience, a potential area of further research may be to integrate amino acid supplementation into a multi-dimensional approach based on diet, nutritional support and molecularly targeted drugs for the management of cancer cachexia.