Additive Duloxetine for Cancer-Related Neuropathic Pain Nonresponsive or Intolerant to Opioid-Pregabalin Therapy: A Randomized Controlled Trial (JORTC-PAL08)

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 SakaiYoshinobu Matsuda, Tatsuya Morita, Atsuko Koyama, Takuhiro Yamaguchi

Research output: Contribution to journalArticlepeer-review

3 Citations (Scopus)

Abstract

Context: Although 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. Objectives: We investigated the efficacy of duloxetine for CNP nonresponsive or intolerant to opioid-pregabalin combination therapy. Methods: A 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. Results: Seventy 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). Conclusion: Adding duloxetine to opioid-pregabalin therapy might have clinical benefit in alleviating refractory CNP. Further studies are needed to conclude the efficacy of adding duloxetine.

Original languageEnglish
Pages (from-to)645-653
Number of pages9
JournalJournal of Pain and Symptom Management
Volume58
Issue number4
DOIs
Publication statusPublished - 2019 Oct

Keywords

  • Pain
  • cancer-related neuropathic pain
  • duloxetine
  • opioid-pregabalin therapy
  • randomized controlled trial

ASJC Scopus subject areas

  • Nursing(all)
  • Clinical Neurology
  • Anesthesiology and Pain Medicine

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