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International Journal of Clinical Oncology

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01-10-2015 | Original Article

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

Authors: Yasuo Hirayama, Kunihiko Ishitani, Yasushi Sato, Satoshi Iyama, Kohichi Takada, Kazuyuki Murase, Hiroyuki Kuroda, Yasuhiro Nagamachi, Yuichi Konuma, Akihito Fujimi, Tamotsu Sagawa, Kaoru Ono, Hiroto Horiguchi, Takeshi Terui, Kazuhiko Koike, Toshiro Kusakabe, Tsutomu Sato, Rishu Takimoto, Masayoshi Kobune, Junji Kato

Published in: International Journal of Clinical Oncology | Issue 5/2015

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.

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Title: Effect of duloxetine in Japanese patients with chemotherapy-induced peripheral neuropathy: a pilot randomized trial
Authors: Yasuo Hirayama
Kunihiko Ishitani
Yasushi Sato
Satoshi Iyama
Kohichi Takada
Kazuyuki Murase
Hiroyuki Kuroda
Yasuhiro Nagamachi
Yuichi Konuma
Akihito Fujimi
Tamotsu Sagawa
Kaoru Ono
Hiroto Horiguchi
Takeshi Terui
Kazuhiko Koike
Toshiro Kusakabe
Tsutomu Sato
Rishu Takimoto
Masayoshi Kobune
Junji Kato
Publication date: 01-10-2015
Publisher: Springer Japan
Published in: International Journal of Clinical Oncology / Issue 5/2015
Print ISSN: 1341-9625
Electronic ISSN: 1437-7772
DOI: https://doi.org/10.1007/s10147-015-0810-y

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Abstract

Background

Methods

Results

Conclusions

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