Journal of Molecular Medicine

, Volume 88, Issue 1, pp 85–92 | Cite as

Phase II nonrandomized study of the efficacy and safety of COX-2 inhibitor celecoxib on patients with cancer cachexia

  • Giovanni MantovaniEmail author
  • Antonio Macciò
  • Clelia Madeddu
  • Roberto Serpe
  • Giorgia Antoni
  • Elena Massa
  • Mariele Dessì
  • Filomena Panzone
Original Article


Chronic inflammation is one of the main features of cancer cachexia. Experimental and clinical studies showed that cyclooxygenase-2 inhibitors, such as celecoxib, may be beneficial in counteracting major symptoms of this devastating syndrome. We carried out a prospective phase II clinical trial to test the safety and effectiveness of an intervention with the COX-2 inhibitor celecoxib (300 mg/day for 4 months) on key variables of cachexia (lean body mass, resting energy expenditure, serum levels of proinflammatory cytokines, and fatigue) in patients with advanced cancer at different sites. A sample of 24 patients was enrolled from January to December 2008 and all were deemed assessable. A significant increase of lean body mass and a significant decrease of TNF-α were observed. Moreover, an improvement of grip strength, quality of life, performance status, and Glasgow prognostic score was shown. There were no grade 3/4 toxicities. Patient compliance was very good; no patient had to reduce the celecoxib dosage nor interrupt treatment. Our results showed that the COX-2 selective inhibitor celecoxib is an effective single agent for the treatment of cancer cachexia. Although the treatment of cancer cachexia, a multifactorial syndrome, is more likely to yield success with a multitargeted approach; in the present study, we were able to show that a treatment, such as celecoxib, addressing a single target, albeit very important as chronic inflammation, could have positive effects. Therefore, phase III clinical trials are warranted to test the efficacy and safety of celecoxib.


Cancer cachexia Chronic inflammation COX-2 inhibitors Celecoxib Lean body mass, resting energy expenditure Proinflammatory cytokines Fatigue 



The authors take full responsibility for the content of the paper but thank Ms. Anna Rita Succa for her assistance in editing the article.

Disclosure statement

The authors have no financial or personal relationships with other people or organizations that could inappropriately influence their work.


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Copyright information

© Springer-Verlag 2009

Authors and Affiliations

  • Giovanni Mantovani
    • 1
    • 2
    Email author
  • Antonio Macciò
    • 1
  • Clelia Madeddu
    • 1
  • Roberto Serpe
    • 1
  • Giorgia Antoni
    • 1
  • Elena Massa
    • 1
  • Mariele Dessì
    • 1
  • Filomena Panzone
    • 1
  1. 1.Department of Medical OncologyUniversity of CagliariCagliariItaly
  2. 2.Cattedra di Oncologia MedicaUniversità di Cagliari, Azienda Ospedaliero-Universitaria di CagliariMonserratoItaly

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