Mantovani, G., Macciò, A., Madeddu, C., Gramignano, G., Serpe, R., Massa, E., . . . Floris, C. (2008). Randomized phase III clinical trial of five different arms of treatment for patients with cancer cachexia: interim results. Nutrition, 24, 305–313.doi: 10.1016/j.nut.2007.12.010
All patients received basic treatment with polyphenols (300 mg/day) from alimentary sources (e.g., onions, apples, oranges, red wine, and green tea) or supplementary tablets. Patients also received antioxidant agents (a-lipoic acid and carbocisteine), as well as vitamins A, C, and E, orally. All patients then were randomized to one of the following five treatment arm interventions:
The planned treatment duration was four months. Patient outcomes were evaluated at 4, 8, 16, and 24 weeks.
Policlinico Universitario and Ospedale Oncologico Regionale, Cagliari, Italy
The study was a randomized, phase II, two-center clinical trial with five treatment arms.
Multidimensional Fatigue Symptom Inventory–Short Form (MFSI-SF)
When comparing baseline and posttreatment measures, statistically significant improvements in fatigue outcomes were observed in the L-carnitine treatment arm (p = 0.039) and the MPA/MA plus pharmacologic nutritional support, L-carnitine, and thalidomide arm (p = 0.015). Fatigue worsened significantly in patients receiving EPA-enriched oral supplementation treatment (p = 0.051).