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Randomized Controlled Trial
. 2015 Oct;20(5):866-71.
doi: 10.1007/s10147-015-0810-y. Epub 2015 Mar 12.

Effect of duloxetine in Japanese patients with chemotherapy-induced peripheral neuropathy: a pilot randomized trial

Yasuo Hirayama  1 , Kunihiko Ishitani  2 , Yasushi Sato  3 , Satoshi Iyama  3 , Kohichi Takada  3 , Kazuyuki Murase  3 , Hiroyuki Kuroda  4 , Yasuhiro Nagamachi  5 , Yuichi Konuma  6 , Akihito Fujimi  7 , Tamotsu Sagawa  8 , Kaoru Ono  3 , Hiroto Horiguchi  3 , Takeshi Terui  9 , Kazuhiko Koike  2 , Toshiro Kusakabe  9 , Tsutomu Sato  3 , Rishu Takimoto  3 , Masayoshi Kobune  3 , Junji Kato  3
Affiliations
Randomized Controlled Trial

Effect of duloxetine in Japanese patients with chemotherapy-induced peripheral neuropathy: a pilot randomized trial

Yasuo Hirayama et al. Int J Clin Oncol. 2015 Oct.

Abstract

Background: Chemotherapy-induced peripheral neuropathy (CIPN) is difficult to manage. A phase III trial conducted in the United States demonstrated that duloxetine was effective for CIPN caused by taxane and platinum-based chemotherapy. No randomized trial of duloxetine for CIPN has been conducted in Japan.

Methods: In this open-label, randomized, crossover study, eligible patients were randomized to Group A or Group B. Group A received duloxetine 20 mg/day orally for the first week and 40 mg/day for the next 3 weeks. Group B received vitamin B12 (VB12) 1.5 mg/day orally for 4 weeks. After a 2- to 4-week washout period, treatment was crossed over for another 4 weeks. The severity of numbness and pain was assessed using a visual analog scale (VAS).

Results: Thirty-four patients were enrolled. Obvious decreases in the mean VAS scores for numbness and pain were observed for the periods of duloxetine administration. Significant differences were observed between the duloxetine-first (Group A) and the VB12-first (Group B) groups with respect to numbness (p = 0.03) and pain (p = 0.04) at 4 weeks after administration. Fatigue was observed in six of the 34 participants (17.6 %).

Conclusions: Our data suggests that duloxetine has a beneficial effect on CIPN caused by oxaliplatin, paclitaxel, vincristine, or bortezomib in Japanese patients.

Keywords: CIPN; Chemotherapy; Duloxetine; Neuropathy; Supportive care.

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