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.

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.

• Authors: Miguel Ángel Cuervo Pinna, Eduardo Bruera, María José Redondo Moralo, Miguel Ángel Sánchez Correas, Rafael Mota Vargas
• Journal: The American journal of hospice & palliative care (Am J Hosp Palliat Care) Vol. 32 Issue 3 Pg. 298-304 (May 2015) ISSN: 1938-2715 [Electronic] United States
• PMID: 24259406 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: © The Author(s) 2013.

Chemical References

• Analgesics, Opioid
• Fentanyl

Topics

• Aged
• Analgesics, Opioid (administration & dosage, therapeutic use)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Dyspnea (drug therapy, etiology)
• Female
• Fentanyl (administration & dosage, therapeutic use)
• Humans
• Male
• Middle Aged
• Neoplasm Staging
• Neoplasms (complications)
• Oral Mucosal Absorption
• Pain (etiology)
• Physical Exertion (drug effects)