title: A randomized crossover clinical trial to evaluate the efficacy of oral transmucosal fentanyl citrate in the treatment of dyspnea on exertion in patients with advanced cancer.
abstract: BACKGROUND
  Morphine is the only opioid which has been clearly demonstrated as effective in the treatment of dyspnea. The role of other opioids has not been sufficiently substantiated.
  
  
  OBJECTIVE
  To evaluate the efficacy of oral transmucosal fentanyl citrate (OTFC) in the treatment of dyspnea on exertion in patients with advanced cancer.
  
  
  METHODS
  This is a randomized, double-blind crossover clinical trial to evaluate the efficacy of OTFC in dyspnea on exertion after the completion of a 6-minute walk test (6MWT). All patients were attended in 2011 by the Palliative Care Supportive Team from Badajoz. In visit 1, patients were randomly assigned to 1 of the 2 treatment groups. In visit 2, the patients who had been receiving the investigational product were given placebos and vice versa.
  
  
  RESULTS
  Thirteen patients were recruited (26 6MWT), with a mean age of 65 years. Of the patients, 11 (76%)were males and lung cancer was the most frequently represented etiology. The patients were classified into 3e categories: better response in the first period, the same response in both the periods, and better response in the second period. No differences between the treatments were demonstrated (P: 1). There were no differences in changes in oxygen saturation (P: .7541) nor in the distance walked in the different sequences (P: .6550). No significant differences were found in relation to the Edmonton Symptom Assessment System, either before or after the 6MWT (P: .1234). No secondary effects associated with the medication were observed.
  
  
  CONCLUSIONS
  It could not be demonstrated that the OTFC improved exertion dyspnea in patients with advanced cancer. A placebo effect was observed in all the patients.
authors.affiliation: Palliative Care Team of Badajoz, Regional Programme for Palliative Care in Extremadura, Badajoz, Spain miguelangel.cuervop@gmail.com.
authors.forename: Miguel Ángel Cuervo
authors.initials: MÁ
authors.lastname: Pinna
authors.affiliation: Department of Palliative Care & Rehabilitation Medicine, F.T. McGraw Chair in the Treatment of Cancer Houston, Houston, TX, USA.
authors.forename: Eduardo
authors.initials: E
authors.lastname: Bruera
authors.affiliation: Palliative Care Team of Badajoz, Regional Programme for Palliative Care in Extremadura, Badajoz, Spain.
authors.forename: María José Redondo
authors.initials: MJ
authors.lastname: Moralo
authors.affiliation: Palliative Care Team of Badajoz, Regional Programme for Palliative Care in Extremadura, Badajoz, Spain.
authors.forename: Miguel Ángel Sánchez
authors.initials: MÁ
authors.lastname: Correas
authors.affiliation: Palliative Care Team of Badajoz, Regional Programme for Palliative Care in Extremadura, Badajoz, Spain.
authors.forename: Rafael Mota
authors.initials: RM
authors.lastname: Vargas
mesh_terms: D000368:Aged; D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004417:Dyspnea / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009369:Neoplasms / Q000150:complications*; D065568:Oral Mucosal Absorption; D010146:Pain / Q000209:etiology; D005082:Physical Exertion / Q000187:drug effects*
chemical_list: D000701:Analgesics, Opioid; D005283:Fentanyl
keywords: advanced cancer; dyspnea; exertion; oral transmucosal fentanyl citrate