一项评估含地塞米松漱口水预防乳腺癌患者化疗引起的口腔炎的随机III期研究。
A randomized phase III study evaluating dexamethasone-based mouthwash to prevent chemotherapy-induced stomatitis in patients with breast cancer.
作者信息
Kuba Sayaka, Soutome Sakiko, Hagiwara Yasuhiro, Kikawa Yuichiro, Iwamoto Takayuki, Sangai Takafumi, Harao Michiko, Yamaguchi Takeshi, Taji Tomoe, Igarashi Ataru, Kajimoto Yusuke, Sakurai Naomi, Yamanouchi Kosho, Watanabe Kenichi, Maeda Noriko, Suzuki Masahiko, Maeda Shigeto, Toh Uhi, Ebata Akiko, Iwakuma Nobutaka, Matsunuma Ryoichi, Yamaguchi Miki, Mukai Hirofumi
机构信息
Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki 852-8102, Japan.
Department of Oral Health, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki 852-8102, Japan.
出版信息
Jpn J Clin Oncol. 2025 Feb 4;55(2):172-175. doi: 10.1093/jjco/hyae136.
Stomatitis, which is a common side effect of chemotherapy, currently lacks a standardized approach for its prevention. Therefore, this multicenter, randomized, open-label, controlled phase III trial aims to assess the efficacy and safety of a dexamethasone-based mouthwash for preventing chemotherapy-induced stomatitis in patients with early breast cancer. We will randomly assign 230 patients with early breast cancer scheduled to receive chemotherapy in a 1:1 ratio to either the dexamethasone-based mouthwash group (10 ml, 0.1 mg/ml; swish for 2 min and spit 4 times daily for 8 weeks) or the mouthwash-with-tap-water group. The incidence of stomatitis, measured using electronic patient-reported outcomes, is the primary endpoint.
口腔炎是化疗常见的副作用，目前缺乏标准化的预防方法。因此，这项多中心、随机、开放标签、对照的III期试验旨在评估一种以地塞米松为基础的漱口水预防早期乳腺癌患者化疗引起的口腔炎的疗效和安全性。我们将按1:1的比例将230名计划接受化疗的早期乳腺癌患者随机分为地塞米松漱口水组（10毫升，0.1毫克/毫升；每天含漱2分钟，吐出4次，共8周）或自来水漱口水组。使用电子患者报告结局测量的口腔炎发生率是主要终点。
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