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<h5 class="section-title" id="d5205797e140">Context</h5>
<p id="P1">Episodic breathlessness is common and debilitating in cancer patients.</p>
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<h5 class="section-title" id="d5205797e145">Objectives</h5>
<p id="P2">In this pilot study, we examined the effect of prophylactic fentanyl pectin
nasal
spray (FPNS) on exercise-induced dyspnea, physiologic function and adverse events.
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<h5 class="section-title" id="d5205797e150">Methods</h5>
<p id="P3">In this parallel, double-blind randomized placebo-controlled trial, opioid-tolerant
patients performed three six-minute walk tests (6MWT) to induce dyspnea. They were
randomized to receive either FPNS (15−25% of total daily opioid dose each time) or
placebo 20 minutes before the second and third 6MWTs. We compared dyspnea numeric
rating scale (NRS, 0−10, primary outcome), walk distance, vital signs, neurocognitive
function and adverse events between the first and second 6MWTs (T2-T1) and between
the first and third 6MWTs (T3-T1).
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<h5 class="section-title" id="d5205797e155">Results</h5>
<p id="P4">Twenty-four patients enrolled, with 96% completion. FPNS was associated
with significant
within-arm reduction in dyspnea NRS at rest (T2-T1: −0.9 [95% confidence interval
[CI] −1.7,−0.1]; T3-T1: −1.3 [95% CI −2.0,−0.5]) and after six minutes (T2-T1: −2.0
[95% CI −3.5,−0.6]; T3-T1: −2.3 [95% CI −4.0,−0.7]), and longer walk distance (T2-T1
+23.8m [95% CI +1.3,+46.2m]; T3-T1: +23.3m [95% CI −1.7,+48.2]). In the placebo arm,
we observed no significant change in walk distance nor dyspnea NRS at rest, but significant
reduction in dyspnea NRS at 6 minutes (T2-T1: −1.7 [95% CI −3.3,−0.1]; T3-T1: −2.5
[95% CI −4.2,−0.9]). Vital signs, neurocognitive function and adverse effects did
not differ significantly.
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<h5 class="section-title" id="d5205797e160">Conclusion</h5>
<p id="P5">FPNS was safe, reduced dyspnea at rest and increased walk distance in before-after
comparison. The placebo effect was substantial, which needs to be factored in future
study designs.(
<a data-untrusted="" href="http://clinicaltrials.gov" id="d5205797e164" target="xrefwindow">clinicaltrials.gov</a>
registration: NCT01832402)
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