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.

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:

1. Progestational agent medroxyprogesterone acetate (MPA) 500 mg/day or megestrol acetate (MA) 320 mg/day
2. Oral supplementation of eicosapentaenoic acid (EPA)-enriched nutritional supplements, with docosahexaenoic acid, high-calorie, and high-protein content
3. L-carnitine 4 g/day, orally
4. Thalidomide 200 mg/day, orally
5. MPA or MA plus pharmacologic nutritional support, L-carnitine, and thalidomide.

The planned treatment duration was four months. Patient outcomes were evaluated at 4, 8, 16, and 24 weeks.

• The sample was comprised of 125 adult patients with cancer and cancer cachexia (mean age = 69.1 years [range 35–80]).
• The male/female ratio was 74/51.
• A majority (83%) of patients experienced more than 5% weight loss before study entry and were stage IV (94.4%).
• Patients had varied diagnoses, the most common being lung (14.4%) and breast (14.4%) cancer.
• Patients were excluded if they were women of child-bearing age, had significant comorbidities, had a mechanical obstruction to feeding, underwent medical treatments that induced significant changes to body metabolism or weight, or had contradiction to MPA or MA.

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).

• No placebo arm was included because an approved drug for cancer cachexia treatment was available at the time of study (MPA or MA).
• The results were from an interim report.