EffenDys—Fentanyl Buccal Tablet for the Relief of Episodic Breathlessness in Patients With Advanced Cancer: A Multicenter, Open-Label, Randomized, Morphine-Controlled, Crossover, Phase II Trial

Simon, Steffen T.; Kloke, Marianne; Alt-Epping, Bernd; Gärtner, Jan; Hellmich, Martin; Hein, Rebecca; Piel, Maren; Cornely, Oliver A.; Nauck, Friedemann; Voltz, Raymond

doi:10.1016/j.jpainsymman.2016.05.023

Cited by 29 publications

(34 citation statements)

References 21 publications

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“…Although only 6 patients were recruited, the investigators reported that FBT had a non-statistically significant trend towards faster onset and greater efficacy for breakthrough dyspnea relief. (21)…”

Section: Discussionmentioning

confidence: 99%

“…(19, 20) A recent crossover trial of 6 patients reported that FBT had a faster onset of action than oral morphine for episodic dyspnea. (21) A better understanding of FBT's effect on exertional dyspnea may open up novel therapeutic options for this distress symptom. In this pilot placebo-control randomized controlled trial, we estimated the within-arm effects of prophylactic FBT and placebo on the intensity of exercise-induced episodic dyspnea.…”

Section: Introductionmentioning

confidence: 99%

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Effect of Prophylactic Fentanyl Buccal Tablet on Episodic Exertional Dyspnea: A Pilot Double-Blind Randomized Controlled Trial

Hui

Kilgore

Frisbee-Hume

et al. 2017

Journal of Pain and Symptom Management

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Context Episodic dyspnea is one of the most common, debilitating and difficult-to-treat symptoms. Objective We conducted a pilot study to examine the effect of prophylactic FBT on exercise-induced dyspnea. Methods In this parallel, double-blind randomized placebo-controlled trial, opioid-tolerant patients were asked to complete a 6 minute walk test (6MWT) at baseline, then a second 6MWT 30 minutes after a single dose of FBT (equivalent to 20-50% of their total opioid dose) or matching placebo. We compared dyspnea numeric rating scale (NRS, 0-10, primary outcome), walk distance, vital signs, neurocognitive function and adverse events between the two 6MWTs. Results Among 22 patients enrolled, 20 (91%) completed the study. FBT was associated with a significant within-arm reduction in dyspnea NRS between 0 and 6 minutes (mean change -2.4, 95% confidence interval [CI] -3.5, -1.3) and respiratory rate (mean change -2.6, 95% CI -4.7, -0.4). Placebo was also associated with a non-statistically significant decrease in dyspnea (mean change -1.1). Between arm comparison of dyspnea scores in the second 6MWT favored FBT, albeit not statistically significant (estimate -0.25, P=0.068). Global impression revealed more patients in the FBT group than placebo group reporting their dyspnea was at least “somewhat better” in the second 6MWT (4/9 vs. 0/11, P=0.03). The other secondary outcomes did not differ significantly between arms. Conclusions This study supports that prophylactic FBT was associated with a reduction of exertional dyspnea and was well-tolerated. Our findings support the need for larger trials to confirm the therapeutic potential of rapid-onset opioids.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Effect of Prophylactic Fentanyl Buccal Tablet on Episodic Exertional Dyspnea: A Pilot Double-Blind Randomized Controlled Trial

Hui

Kilgore

Frisbee-Hume

et al. 2017

Journal of Pain and Symptom Management

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“…Preliminary data from a small randomised trial comparing fentanyl buccal tablet with morphine sulfate for treatment of episodic breathlessness suggested that fentanyl had a faster onset and provided greater relief. 71 Several small placebo-controlled trials have examined the use of prophylactic fentanyl given prior to exertion in opioid-tolerant patients with cancer and reported a benefit (discussed below). [72][73][74] Taken together, the available evidence signals that opioids have a positive effect on breathlessness among opioid-tolerant individuals, giving justification for further studies to examine these findings in confirmatory trials and to determine the optimal dose and timing of opioids for breathlessness.…”

Section: Opioidsmentioning

confidence: 99%

Management of breathlessness in patients with cancer: ESMO Clinical Practice Guidelines

et al. 2020

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“…Breathlessness scores decreased linearly from 10 to 60 min post-treatment completion [ 23 ]. In a randomized cross-over study performed in a real-life clinical setting, focused on exertional EB, the mean times to onset for fentanyl buccal tablet and oral morphine were 12.7 and 23.6 min, respectively [ 24 ]. Considering that about 80% of episodes last ≤10 min, it is likely that the effect is produced by the natural course of EB, with a spontaneous disappearance, particularly when EB is induced by an effort, possibly stopped after EB occurred [ 25 ].…”

Section: Discussionmentioning

confidence: 99%

Episodic Breathlessness with and without Background Dyspnea in Advanced Cancer Patients Admitted to an Acute Supportive Care Unit

Mercadante

Adile

Ferrera

et al. 2020

Cancers

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Aim: To characterize episodic breathlessness (EB) in patients with advanced cancer, and to determine factors influencing its clinical appearance. Methods: A consecutive sample of advanced cancer patients admitted to an acute palliative care unit was surveyed. Continuous dyspnea and EB were measured by a numerical scale. The use of drugs used for continuous dyspnea and EB was recorded. Patients were asked about the characteristics of EB (frequency, intensity, duration and triggers). The Multidimensional dyspnea profile (MDP), the Brief dyspnea inventory (BDI), the Athens sleep scale (AIS) and the Hospital Anxiety and Depression Scale (HADS) were also administered. Results: From 439 advanced cancer patients surveyed, 34 and 27 patients had EB, without and with background dyspnea, respectively. The mean intensity and the number of episodes were higher in patients with background dyspnea (p < 0.0005 and p = 0.05, respectively). No differences in duration were observed. Most episodes lasted <10 min. A recognizable cause triggering EB was often found. The presence of both background dyspnea and EB was associated with higher values of MDP and BDI. EB was independently associated with frequency and intensity of background dyspnea (OR = 20.9, 95% CI (Confidence interval) 9.1–48.0; p < 0.0005 and OR = 1.97, 95% CI 1.09–3.58; p = 0.025, respectively) and a lower Karnofsky level (OR = 0.96, 95%CI 0.92–0.98, p = 0.05). Discussion: EB may occur in patients with and without continuous dyspnea, and is often induced by physical and psychological factors. EB intensity is higher in patients with continuous dyspnea. The duration was often so short that the use of drugs, as needed, may be too late, unless administered pre-emptively when the trigger was predictable.

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EffenDys—Fentanyl Buccal Tablet for the Relief of Episodic Breathlessness in Patients With Advanced Cancer: A Multicenter, Open-Label, Randomized, Morphine-Controlled, Crossover, Phase II Trial

Abstract: The description of a faster and greater relief of episodic breathlessness by transmucosal fentanyl versus morphine justifies further evaluation by a full-powered trial.

Cited by 29 publications

References 21 publications

Effect of Prophylactic Fentanyl Buccal Tablet on Episodic Exertional Dyspnea: A Pilot Double-Blind Randomized Controlled Trial

Effect of Prophylactic Fentanyl Buccal Tablet on Episodic Exertional Dyspnea: A Pilot Double-Blind Randomized Controlled Trial

Management of breathlessness in patients with cancer: ESMO Clinical Practice Guidelines

Episodic Breathlessness with and without Background Dyspnea in Advanced Cancer Patients Admitted to an Acute Supportive Care Unit

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