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

I have read with interest the article “Fentanyl for the Relief of Refractory Breathlessness: A Systematic Review.” Our research group has carried out a randomized, double-blind, crossover clinical trial to evaluate the efficacy of oral transmucosal fentanyl citrate (OTFC; 200–400 μg) in dyspnea on exertion after the completion of a six-minute walk test (6MWT) (EudraCT no. 2012-021399-26). All patients were attended in 2011 by the Palliative Care Supportive Team from Badajoz, Spain. On Visit 1, patients were randomly assigned to one of the two treatment groups, and on the second visit, the patients who had been receiving the investigational product were given placebos and vice versa. Thirteen patients were recruited (26 6MWT). The patients were classified into three categories: better response in the first period, the same response in both 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: 0.754) nor in the distance walked in the different sequences (P: 0.655). No significant differences were found in relation to the Edmonton Symptom Assessment System, either before or after the 6MWT (P: 0.123). No secondary effects associated with the medication were observed. It could not be demonstrated that the OTFC improved exertion dyspnea in patients with advanced cancer. A placebo effect was observed in all patients.
Source: Journal of Pain and Symptom Management - Category: Palliative Care Authors: Tags: Letters Source Type: research