Feb. 02, 2022 |
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Feb. 02, 2022 |
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jRCTs031210593 |
Preoperative steroid for enhancing patients` recovery after head and neck cancer surgery with free tissue transfer reconstruction; a phase III, placebo-controlled, randomized, double-blinded study (PreSte-HN) |
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Phase III study of preoperative steroid compared with placebo for head and neck cancer surgery (PreSte-HN) |
Matsuura Kazuto |
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National Cancer Center Hospital East |
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6-5-1 Kashiwanoha Kashiwa Chiba |
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+81-4-7133-1111 |
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kmatsuur@east.ncc.go.jp |
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Shinozaki Tsuyoshi |
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National Cancer Center Hospital East |
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6-5-1 Kashiwanoha Kashiwa Chiba |
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+81-4-7133-1111 |
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tashinoz@east.ncc.go.jp |
Recruiting |
Feb. 02, 2022 |
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180 | ||
Interventional |
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randomized controlled trial |
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double blind |
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placebo control |
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parallel assignment |
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treatment purpose |
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1) Twenty years old or more |
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1) Hypersensitivity with dexamethasone |
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20age old over | ||
No limit | ||
Both |
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Head and Neck Neoplasms |
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Arm A: Perioperative management with ERAS without preoperative steroid administration |
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Head and Neck Cancer |
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Randomized Controlled Trial |
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D006258 |
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D016449 |
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Quality of postoperative recovery (AUC values of QOR40-J total score on postoperative day2 and day4) |
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Key secondary endpoint |
Japan Agency for Medical Research and Development | |
Not applicable |
National Cancer Center Hospital East Certified Review Board | |
6-5-1 Kashiwanoha Kashiwa Chiba, Chiba | |
+81-4-7133-1111 |
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ncche-irb@east.ncc.go.jp | |
Approval | |
Dec. 22, 2021 |
No |
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none |