Mantovani, G., Macciò, A., Madeddu, C., Gramignano, G., Lusso, M. R., Serpe, R., . . . Deiana, L. (2006). A phase II study with antioxidants, both in the diet and supplemented, pharmaconutritional support, progestagen, and anti-cyclooxygenase-2 showing efficacy and safety in patients with cancer-related anorexia/cachexia and oxidative stress. Cancer Epidemiology, Biomarkers and Prevention, 15, 1030–1034.
DOI Link
Intervention Characteristics/Basic Study Process
The integrated treatment consisted of the following components:
- High polyphenols content (400 mg)
- Antioxidant treatment (300 mg/d a-lipoic acid + 2.7 g/d carbocisteine lysine salt + 400 mg/d vitamin E + 30,000 IU/d vitamin A + 500 mg/d vitamin C)
- Pharmaconutritional support enriched with 2 cans per day (n-3) polyunsaturated fatty acids (PUFA) (eicosapentaenoic acid and docosahexaenoic acid), 500 mg/d medroxyprogesterone acetate, and 200 mg/d selective cyclooxygenase-2-inhibitor celecoxib.
Patient outcomes were assessed at baseline and one, two, and four months.
Sample Characteristics
- The sample included 39 patients with cancer-related anorexia/cachexia syndrome (CACS).
- Mean age was 58.9 years (range 42–78).
- The majority of patients were male (n = 23).
- Patients had multiple tumor sites, but the most common was head and neck (43.6%); 97.4% were stage IV.
Setting
Phase of Care and Clinical Applications
Patients were undergoing the active treatment phase of care.
Study Design
This was an open, early-phase II study.
Measurement Instruments/Methods
Multidimensional Fatigue Symptom Inventory–Short Form (MFSI-SF)
Results
Compared to baseline scores, fatigue outcomes improved at two months (p = 0.22) and more so at four months (p = 0.004). No correlation existed between changes in fatigue and changes in any other variable studied.
Limitations
- The study lacked a neutral comparison group.
- The study had a small sample size.