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:

  1. High polyphenols content (400 mg)
  2. 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)
  3. 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

Not identified

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.