• Hiromichi Matsuoka, Satoru Iwase, Tempei Miyaji, Takashi Kawaguchi, Keisuke Ariyoshi, Shunsuke Oyamada, Eriko Satomi, Hiroto Ishiki, Hideaki Hasuo, Hiroko Sakuma, Akihiro Tokoro, Toshiaki Shinomiya, Hiroyuki Otani, Yoichi Ohtake, Hiroaki Tsukuura, Yoshihisa Matsumoto, Yoshikazu Hasegawa, Yuki Kataoka, Masatomo Otsuka, Kiyohiro Sakai, Yoshinobu Matsuda, Tatsuya Morita, Atsuko Koyama, and Takuhiro Yamaguchi.
• Improving Palliative, Aged and Chronic Care through Clinical Research and Translation (IMPACCT) and Palliative Care Clinical Studies Collaborative (PaCCSC), University of Technology Sydney, Sydney, Australia; Department of Psychosomatic Medicine, Kindai University Faculty of Medicine, Osaka, Japan. Electronic address: matsuoka_h@med.kindai.ac.jp.
• J Pain Symptom Manage. 2019 Oct 1; 58 (4): 645-653.

ContextAlthough opioids and pregabalin are widely used for cancer-related neuropathic pain (CNP), no clinical trials exist to determine which medications are effective when an opioid-pregabalin combination therapy fails.ObjectivesWe investigated the efficacy of duloxetine for CNP nonresponsive or intolerant to opioid-pregabalin combination therapy.MethodsA multicenter, randomized, double-blind, placebo-controlled trial was performed at 12 specialized palliative care services in Japan. Patients with CNP average pain scores (Brief Pain Inventory [BPI]-Item 5) ≥ 4 in the previous 24 hours and nonresponsive or intolerant to opioid-pregabalin combination therapy were eligible. Patients with chemotherapy-induced peripheral neuropathies were excluded. Patients were administered duloxetine 20 mg/day titrated to 40 mg/day or placebo for 10 days. The primary endpoint was BPI-Item 5 on Day 10. Responder analysis measured proportions of patients with 30% and 50% pain decreases.ResultsSeventy patients were enrolled. Complete case analysis revealed mean BPI-Item 5 on Day 10 of 4.03 for Group D vs. 4.88 for Group P (P = 0.053). Baseline observation carried forward analysis revealed mean BPI-Item 5 on Day 10 of 4.06 and 4.91 for Groups D and P, respectively (P = 0.048). Clinically meaningful pain improvement (≥30%) was reported by 44.1% (n = 15) of patients in Group D vs. 18.2% (n = 6) in Group P (P = 0.02); 32.4% (n = 11) vs. 3.0% (n = 1) of patients in Groups D and P, respectively, reported pain reduction ≥ 50% (P = 0.002).ConclusionAdding duloxetine to opioid-pregabalin therapy might have clinical benefit in alleviating refractory CNP. Further studies are needed to conclude the efficacy of adding duloxetine.Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.

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