Fentanyl Buccal Tablet or Morphine for Exertional Dyspnea in Cancer Patients

Phase 3 Active not recruiting 150 enrolled M.D. Anderson Cancer Center National Cancer Institute (NCI) · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

This phase II trial studies fentanyl buccal tablet or morphine to see how well it works compared to a placebo in controlling shortness of breath during or after physical activity in cancer patients. Fentanyl sublingual tablet and morphine are opioids normally used to control pain that may also help to prevent or control shortness of breath during or after physical activity in cancer patients.

Timeline

Start: 2020-10-23
Primary completion: 2027-08-31
Completion: 2027-08-31

Outcome

Missed primary endpoint

paper no significant difference by treatment group PMID 41115797 ↗

paper treatment×time effect p=0.79 PMID 41115797 ↗

Publications

Hui D, Pacheco S, Nguyen L, Jennings K, de la Cruz V, Stanton P, Laureano R, Ontai A, Mahler D, Bruera E. Efficacy of fentanyl buccal tablet and morphine for exertional dyspnoea in patients with cancer: a double-blind, placebo-controlled, randomised clinical trial. Thorax. 2026 Mar 13;81(4):344-356. doi: 10.1136/thorax-2025-222970.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fentanyl	Other / unclassified	—	Other
Subject	Morphine	Other / unclassified	—	Oral