Taishi Hata1, Michitaka Honda2, Michiya Kobayashi3, Akihiro Toyokawa4, Masahiro Tsuda5, Yukihiko Tokunaga6, Kozo Takase7, Masakazu Miyake8, Satoshi Morita9, Naoki Nagata10, Junichi Sakamoto11, Masahiko Gosho12, Hideyuki Mishima13. 1. Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan. 2. Department of Gastroenterological Surgery, Gastroenterological Center, Cancer Institute Ariake Hospital, Japanese Foundation for Cancer Research, 3-10-6 Ariake, Koto-ku, Tokyo, 135-8550, Japan. michitaka.honda@jfcr.or.jp. 3. Department of Human Health and Medical Sciences, Kochi Medical School, Kochi, Japan. 4. Department of Surgery, Yodogawa Christian Hospital, Osaka, Japan. 5. Department of Gastroenterological Oncology, Hyogo Cancer Center, Hyogo, Japan. 6. Department of Surgery, Japan Post Kyoto Teishin Hospital, Kyoto, Japan. 7. Department of Surgery, Hyogo Cancer Center, Hyogo, Japan. 8. Department of Surgery, Osaka National Hospital, Osaka, Japan. 9. Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan. 10. Kitakyushu General Hospital, Fukuoka, Japan. 11. Tokai Central Hospital, Gifu, Japan. 12. Advanced Medical Research Center, Aichi Medical University, Aichi, Japan. 13. Division of Cancer Center, Aichi Medical University, Aichi, Japan.
Abstract
PURPOSE: The aim of this phase II clinical trial was to evaluate the preventive effect of dexamethasone mixing injection for venous pain in patients with colorectal cancer during chemotherapy. MATERIALS AND METHODS: Patients were randomized to receive a 2-h intravenous infusion of oxaliplatin 130 mg/m(2) on day 1 followed by capecitabine 1000 mg/m(2) (or S-1 40-60 mg/m(2)) twice daily on days 1 through 14 of every 3 weeks with or without dexamethasone 1.65 mg at the infusion on day 1. RESULTS: A total of 53 patients were enrolled. The analysis population consisted of 49 patients (arm A, with dexamethasone N = 24; arm B, without dexamethasone N = 25). The incidence of venous pain ≥grade 2 based on the CTCAE version 4.0 was 33.3 % in arm A and 56.0 % in arm B (relative risk 0.60; 95 % CI 0.31-1.16). The incidences based on the verbal rating scale for arms A and B were 50.0 and 64.0 %, respectively (relative risk 0.78; 95 % CI 0.48-1.28). CONCLUSION: The primary endpoint was not met in this preliminary study.
RCT Entities:
PURPOSE: The aim of this phase II clinical trial was to evaluate the preventive effect of dexamethasone mixing injection for venous pain in patients with colorectal cancer during chemotherapy. MATERIALS AND METHODS:Patients were randomized to receive a 2-h intravenous infusion of oxaliplatin 130 mg/m(2) on day 1 followed by capecitabine 1000 mg/m(2) (or S-1 40-60 mg/m(2)) twice daily on days 1 through 14 of every 3 weeks with or without dexamethasone 1.65 mg at the infusion on day 1. RESULTS: A total of 53 patients were enrolled. The analysis population consisted of 49 patients (arm A, with dexamethasone N = 24; arm B, without dexamethasone N = 25). The incidence of venous pain ≥grade 2 based on the CTCAE version 4.0 was 33.3 % in arm A and 56.0 % in arm B (relative risk 0.60; 95 % CI 0.31-1.16). The incidences based on the verbal rating scale for arms A and B were 50.0 and 64.0 %, respectively (relative risk 0.78; 95 % CI 0.48-1.28). CONCLUSION: The primary endpoint was not met in this preliminary study.