一项随机 III 期研究，评估地塞米松漱口水对乳腺癌患者化疗引起的口腔炎的预防作用。

IF 1.9 4区医学 Q3 ONCOLOGY

Japanese journal of clinical oncology Pub Date : 2024-10-01 DOI:10.1093/jjco/hyae136

Sayaka Kuba, Sakiko Soutome, Yasuhiro Hagiwara, Yuichiro Kikawa, Takayuki Iwamoto, Takafumi Sangai, Michiko Harao, Takeshi Yamaguchi, Tomoe Taji, Ataru Igarashi, Yusuke Kajimoto, Naomi Sakurai, Kosho Yamanouchi, Kenichi Watanabe, Noriko Maeda, Masahiko Suzuki, Shigeto Maeda, Uhi Toh, Akiko Ebata, Nobutaka Iwakuma, Ryoichi Matsunuma, Miki Yamaguchi, Hirofumi Mukai

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引用次数: 0

摘要

口腔炎是化疗的一种常见副作用，目前缺乏一种标准化的预防方法。因此，这项多中心、随机、开放标签、对照 III 期试验旨在评估地塞米松漱口水预防早期乳腺癌患者化疗引起的口腔炎的有效性和安全性。我们将把 230 名计划接受化疗的早期乳腺癌患者按 1:1 的比例随机分配到地塞米松漱口水组（10 毫升，0.1 毫克/毫升；漱口 2 分钟后吐掉，每天 4 次，持续 8 周）或漱口水加自来水组。主要终点是口腔炎的发病率，采用患者报告的电子结果进行测量。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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A randomized phase III study evaluating dexamethasone-based mouthwash to prevent chemotherapy-induced stomatitis in patients with breast cancer.

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.

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来源期刊

Japanese journal of clinical oncology 医学-肿瘤学

CiteScore

3.70

自引率

8.30%

发文量

177

审稿时长

3-8 weeks

期刊介绍： Japanese Journal of Clinical Oncology is a multidisciplinary journal for clinical oncologists which strives to publish high quality manuscripts addressing medical oncology, clinical trials, radiology, surgery, basic research, and palliative care. The journal aims to contribute to the world"s scientific community with special attention to the area of clinical oncology and the Asian region. JJCO publishes various articles types including: ・Original Articles ・Case Reports ・Clinical Trial Notes ・Cancer Genetics Reports ・Epidemiology Notes ・Technical Notes ・Short Communications ・Letters to the Editors ・Solicited Reviews