Cerchietti, L. C., Navigante, A. H., Peluffo, G. D., Diament, M. J., Stillitani, I., Klein, S. A., & Cabalar, M. E. (2004). Effects of celecoxib, medroxyprogesterone, and dietary intervention on systemic syndromes in patients with advanced lung adenocarcinoma: a pilot study. Journal of Pain and Symptom Management, 27, 85–95.

• Medroxyprogesterone (MPA) 500 mg twice daily (BID) + celecoxib 200 mg BID + polymeric diet X 6 weeks
• Enteral food supplementation = 20% ​basal metabolic rate (BMR) with meal advice to caregiver and patient advice to engage in regular exercise.

Systemic-immune metabolic syndrome (SIMS) implies dysregulation of psychoneuroimmunoendocrine homeostasis, resulting in cachexia, anorexia, chronic nausea, early satiety, fatigue, tumor fever, cognitive changes, and superinfections (i.e., increased cytokines may increase cachexia-anorexia syndrome [CAS] and mediate anorexia).

The study included 15 adult outpatients with stage IIIb or IV lung adenocarcinoma.

Patients were included if they 

• Had CAS 10% weight loss
• Had anorexia 5/10 or greater
• Had fatigue 5/10 or greater
• Were not currently treated within one month with surgery, radiotherapy, chemotherapy, steroids, nonsteroidal anti-inflammatory drugs (NSAIDs), appetite stimulants, or progestational agents
• Had no bowel obstruction, ascites, endocrine abnormalities, diabetes mellitus, severe anemia, or bleeding.

The study was conducted in a community outpatient setting in Argentina.

The study used a pilot, open-label, uncontrolled convenience sample design.

Weekly measurements included

• Performance status
• Appetite
• Nausea
• Fatigue Numerical Scale (FNS, 0-10)
• Calculations of lean mass (LM), fat mass (FM), total body water (TBW), caloric intake, mid-arm circumference (MAC), caregiver’s report of volume of supplement consumed, blood chemistry, C-reactive protein (CRP), interleukin-10 (IL-10), and granulocyte-macrophage colony-stimulating factor (GM-CSF) levels.

• Thirteen of eighteen participants showed stable or increased weight compared with prestudy (p = 0.0001).
• Of the patients, 100% had a lowered rate of weight loss.
• Less than 20% of patients followed advice to exercise.
• Significant differences were noted in nausea, fatigue, appetite, performance status, and MAC.
• Some improvement trends were observed in body weight index (BWI) (body mass) and LM.
• No significant differences were noted in FM and TBW.

• The study was uncontrolled.
• The study had a small sample size.
• FNS was the only tool used to measure fatigue.
• Cox-2 inhibitor may prevent reduction of IL-10, causing more infectious complications.

Cost of medications, polymeric diet, and cost of cytokine measurements should be considered.