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Int J Clin Oncol. 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.

Author information

1
Department of Hematology Oncology, Higashi Sapporo Hospital, Higashi Sapporo, Shiroishi-ku, Sapporo, 003-8585, Japan. hirayama@hsh.or.jp.
2
Division of Palliative Care, Higashi Sapporo Hospital, Sapporo, Japan.
3
Department of Medical Oncology/Hematology, Sapporo Medical University School of Medicine, Sapporo, Japan.
4
Department of Hematology Oncology, Seitetsu Memorial Hospital, Muroran, Japan.
5
Department of Hematology Oncology, Kiyota Hospital, Sapporo, Japan.
6
Department of Hematology Oncology, Asahikawa Red Cross Hospital, Asahikawa, Japan.
7
Department of Hematology Oncology, Oji Genaral Hospital, Tomakomai, Japan.
8
Department of Gastroenterology, Hokkaido Cancer Center, Sapporo, Japan.
9
Department of Hematology Oncology, Higashi Sapporo Hospital, Higashi Sapporo, Shiroishi-ku, Sapporo, 003-8585, Japan.

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

PMID:
25762165
DOI:
10.1007/s10147-015-0810-y
[Indexed for MEDLINE]

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