{"title":"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。","authors":"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","doi":"10.1093/jjco/hyae136","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":14656,"journal":{"name":"Japanese journal of clinical oncology","volume":null,"pages":null},"PeriodicalIF":1.9000,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A randomized phase III study evaluating dexamethasone-based mouthwash to prevent chemotherapy-induced stomatitis in patients with breast cancer.\",\"authors\":\"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\",\"doi\":\"10.1093/jjco/hyae136\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>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.</p>\",\"PeriodicalId\":14656,\"journal\":{\"name\":\"Japanese journal of clinical oncology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.9000,\"publicationDate\":\"2024-10-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Japanese journal of clinical oncology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1093/jjco/hyae136\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Japanese journal of clinical oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/jjco/hyae136","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"ONCOLOGY","Score":null,"Total":0}
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.
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
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