• David Hui, Farley Hernandez, Liliana Larsson, Diane Liu, Kelly Kilgore, Jane Naberhuis, Avery Virgilio, Suresh Reddy, Akhila Reddy, Shalini Dalal, Ali Haider, Larry Driver, Ahsan Azhar, Rony Dev, and Eduardo Bruera.
• Department of Palliative Care, Rehabilitation and Integrative Medicine, MD Anderson Cancer Center, Houston, Texas, USA. Electronic address: dhui@mdanderson.org.
• J Pain Symptom Manage. 2019 Oct 1; 58 (4): 605-613.

ContextThe optimal dose of fentanyl sublingual spray (FSS) for exertional dyspnea has not been determined.ObjectivesWe examined the effect of two doses of prophylactic FSS on exertional dyspnea.MethodsIn this parallel, dose-finding, double-blind randomized clinical trial, opioid-tolerant cancer patients completed a shuttle walk test at baseline. Patients completed a second shuttle walk test 10 minutes after a single dose of FSS equivalent to either 35%-45% (high dose) or 15%-25% (low dose) of the total daily opioid dose. The primary outcome was change in modified dyspnea Borg scale (0-10) between the first and second shuttle walk tests. Secondary outcomes included adverse events as well as changes in walk distance, vital signs, and neurocognitive function.ResultsThirty of the 50 enrolled patients completed the study. High-dose FSS (n = 13) resulted in significantly lower dyspnea (mean change -1.42; 95% CI -2.37, -0.48; P = 0.007) and greater walk distance (mean change 44 m; P = 0.001) compared to baseline. Low-dose FSS (n = 17) resulted in a nonsignificant reduction in dyspnea (mean change -0.47; 95% CI -1.26, 0.32; P = 0.24) and significant increase in walk distance (mean change 24 m; P = 0.01) compared to baseline. Global evaluation showed high-dose group was more likely to report at least somewhat better improvement (64% vs. 24%; P = 0.06). No significant adverse events or detriment to vital signs or neurocognitive function was detected.ConclusionProphylactic FSS was well tolerated and demonstrated a dose-response relationship in improving both dyspnea and walk distance. High-dose FSS should be tested in confirmatory trials.Copyright © 2019 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

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