title: Effect of duloxetine in Japanese patients with chemotherapy-induced peripheral neuropathy: a pilot randomized trial.
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.
authors.affiliation: Department of Hematology Oncology, Higashi Sapporo Hospital, Higashi Sapporo, Shiroishi-ku, Sapporo, 003-8585, Japan. hirayama@hsh.or.jp.
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Hirayama
authors.affiliation: Division of Palliative Care, Higashi Sapporo Hospital, Sapporo, Japan.
authors.forename: Kunihiko
authors.initials: K
authors.lastname: Ishitani
authors.affiliation: Department of Medical Oncology/Hematology, Sapporo Medical University School of Medicine, Sapporo, Japan.
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Sato
authors.affiliation: Department of Medical Oncology/Hematology, Sapporo Medical University School of Medicine, Sapporo, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Iyama
authors.affiliation: Department of Medical Oncology/Hematology, Sapporo Medical University School of Medicine, Sapporo, Japan.
authors.forename: Kohichi
authors.initials: K
authors.lastname: Takada
authors.affiliation: Department of Medical Oncology/Hematology, Sapporo Medical University School of Medicine, Sapporo, Japan.
authors.forename: Kazuyuki
authors.initials: K
authors.lastname: Murase
authors.affiliation: Department of Hematology Oncology, Seitetsu Memorial Hospital, Muroran, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Kuroda
authors.affiliation: Department of Hematology Oncology, Kiyota Hospital, Sapporo, Japan.
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Nagamachi
authors.affiliation: Department of Hematology Oncology, Asahikawa Red Cross Hospital, Asahikawa, Japan.
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Konuma
authors.affiliation: Department of Hematology Oncology, Oji Genaral Hospital, Tomakomai, Japan.
authors.forename: Akihito
authors.initials: A
authors.lastname: Fujimi
authors.affiliation: Department of Gastroenterology, Hokkaido Cancer Center, Sapporo, Japan.
authors.forename: Tamotsu
authors.initials: T
authors.lastname: Sagawa
authors.affiliation: Department of Medical Oncology/Hematology, Sapporo Medical University School of Medicine, Sapporo, Japan.
authors.forename: Kaoru
authors.initials: K
authors.lastname: Ono
authors.affiliation: Department of Medical Oncology/Hematology, Sapporo Medical University School of Medicine, Sapporo, Japan.
authors.forename: Hiroto
authors.initials: H
authors.lastname: Horiguchi
authors.affiliation: Department of Hematology Oncology, Higashi Sapporo Hospital, Higashi Sapporo, Shiroishi-ku, Sapporo, 003-8585, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Terui
authors.affiliation: Division of Palliative Care, Higashi Sapporo Hospital, Sapporo, Japan.
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Koike
authors.affiliation: Department of Hematology Oncology, Higashi Sapporo Hospital, Higashi Sapporo, Shiroishi-ku, Sapporo, 003-8585, Japan.
authors.forename: Toshiro
authors.initials: T
authors.lastname: Kusakabe
authors.affiliation: Department of Medical Oncology/Hematology, Sapporo Medical University School of Medicine, Sapporo, Japan.
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Sato
authors.affiliation: Department of Medical Oncology/Hematology, Sapporo Medical University School of Medicine, Sapporo, Japan.
authors.forename: Rishu
authors.initials: R
authors.lastname: Takimoto
authors.affiliation: Department of Medical Oncology/Hematology, Sapporo Medical University School of Medicine, Sapporo, Japan.
authors.forename: Masayoshi
authors.initials: M
authors.lastname: Kobune
authors.affiliation: Department of Medical Oncology/Hematology, Sapporo Medical University School of Medicine, Sapporo, Japan.
authors.forename: Junji
authors.initials: J
authors.lastname: Kato
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects*; D018592:Cross-Over Studies; D000068736:Duloxetine Hydrochloride / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced / Q000188:drug therapy* / Q000517:prevention & control; D010865:Pilot Projects; D000068760:Serotonin and Noradrenaline Reuptake Inhibitors / Q000627:therapeutic use*; D014805:Vitamin B 12 / Q000627:therapeutic use
chemical_list: D000970:Antineoplastic Agents; D000068760:Serotonin and Noradrenaline Reuptake Inhibitors; D000068736:Duloxetine Hydrochloride; D014805:Vitamin B 12
keywords: CIPN; Chemotherapy; Duloxetine; Neuropathy; Supportive care