Background Nonsteroidal anti-inflammatory drugs (NSAIDs) may palliate cachexia by maintaining muscle mass. A recent animal study demonstrated that cyclooxygenase 2 inhibitors (COX-2) reversed tumor-induced wasting in mice bearing human head and neck squamous cell carcinoma and colon carcinomas. Our hypothesis was that NSAIDs given to patients with cancer cachexia will stabilize or reverse their loss of lean body mass.
Methods A prospective, randomized, double-blind, placebo-controlled clinical trial was designed to determine whether intervention with the COX-2 inhibitor celecoxib was effective at improving cancer cachexia in patients with cancer of the head and neck and gastrointestinal (GI) tract. After the clinical diagnosis of cachexia was established, the following measurements were made: weight; body composition via dual x-ray absorptiometry; resting energy expenditure (REE) via indirect calorimetry; quality of life (QoL) surveys via Functional Assessment of Anorexia/Cachexia Therapy (FAACT); and performance status via Karnofsky Performance Scale (KPS). Patients were randomized to receive either celecoxib 200 mg po bid or placebo for 3 weeks. Three weeks later, each patient returned for the same evaluation as on day 1. In this pilot study, no nutritional intervention was made.
Results Eleven patients have completed the study thus far. Seven have received placebo, while four have received active drug. Eight patients have head and neck cancers and three patients have cancer of the GI tract. All were male, with a mean age of 59.1 years. Interim unblinded analysis of the data reveals that, on average, patients taking celecoxib experienced weight gain of 1.0 kg (SE = 1.33), body mass index (BMI) increase of 0.31 (SE = 0.45), lean body mass percent (LBM%) increase of 0.28 (SE = 2.81), and improvement of FAACT score of 10 points (SE = 4). Those taking placebo experienced, on average, weight loss of 1.0 kg (SE = 1.63), BMI decrease of 0.56 (0.68), LBM% drop of 0.04% (SE = 1.60), and no improvement in FAACT score.
Conclusions Promising initial trends were seen in the administration of celecoxib to patients with cancer cachexia in this study, including gains in weight, BMI, LBM%, and QoL score. Future studies may examine cytokine and CRP levels and may include a nutritional intervention in studying the effect of anti-inflammatory therapy on cancer cachexia.