Mantovani, G., Maccio, A., Madeddu, C., Serpe, R., Massa, E., Dessi, M., . . . Contu, P. (2010). Randomized phase III clinical trial of five different arms of treatment in 332 patients with cancer cachexia. Oncologist, 15, 200–211.doi: 10.1634/theoncologist.2009-0153
To determine the most effective and safest treatment to improve primary endpoints of lean body mass, resting energy expenditure, and fatigue in patients with cancer-related anorexia-cachexia syndrome
To determine the effects on secondary endpoints of appetite, quality of life, grip strength, Glasgow Prognostic Score, and proinflammatory cytokines
All patients were given the following standard treatment orally via pills or dietary intake:
Patients were randomly assigned to one of the following five treatment arms:
Planned treatment duration was four months.
The multisite study was conducted in Italy.
The study was a phase III, prospective, randomized trial.
Results demonstrate efficacy of a combined treatment approach in cancer cachexia syndrome.
Results seem to confirm that cancer cachexia, as a multidimensional syndrome, is likely to yield success with a multifactorial approach.
Results appear to confirm thinking that cachexia is driven by inflammatory cytokines and that drugs that down-regulate the production and/or release of proinflammatory cytokines can be effective in reversing the symptoms of the syndrome.
It is noted that the drugs and dietary supplements used are low cost.
Combined treatments used here may indicate an additive or synergistic effect of the agents.