Yasuo Hirayama1, Kunihiko Ishitani2, Yasushi Sato3, Satoshi Iyama3, Kohichi Takada3, Kazuyuki Murase3, Hiroyuki Kuroda4, Yasuhiro Nagamachi5, Yuichi Konuma6, Akihito Fujimi7, Tamotsu Sagawa8, Kaoru Ono3, Hiroto Horiguchi3, Takeshi Terui9, Kazuhiko Koike2, Toshiro Kusakabe9, Tsutomu Sato3, Rishu Takimoto3, Masayoshi Kobune3, Junji Kato3. 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.
RCT Entities:
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.
Entities:
Keywords:
CIPN; Chemotherapy; Duloxetine; Neuropathy; Supportive care
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