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

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. Design: 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. Conclusion: 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.