A four month, phase III, randomized non-inferiority study was conducted to compare a two-drug combination (carnitine + celecoxib) with carnitine + celecoxib + megestrol acetate for the treatment of cancer-related anorexia/cachexia syndrome (CACS). The primary endpoints were increases of lean body mass (LBM) and improvements of total daily physical activity while the secondary endpoint was an increase in physical performance tested by grip strength and a six-minute walk test (6MWT). Sixty eligible patients were randomly assigned to: arm 1 (L-carnitine 4 g/day + Celecoxib 300 mg/day) or arm 2 (L-carnitine 4 g/day + celecoxib 300 mg/day + megestrol acetate 320 mg/day). All patients received polyphenols 300 mg/day, lipoic acid 300 mg/day, carbocysteine 2.7 g/day, and vitamins A, C, and E. The results did not show a significant difference between treatment arms in both primary and secondary endpoints. Analysis of changes from baseline showed that LBM (determined by dual-energy X-ray absorptiometry and L3 computed tomography) increased significantly in both arms as well as physical performance assessed by 6MWT. Toxicity was quite negligible and comparable between arms. This simple, effective, safe, low cost two-drug approach could be suggested in clinical practice to implement CACS treatment. Clin Nutr. 2011 Oct 31. PMID: 22047681
