1. A randomized phase III study evaluating dexamethasone-based mouthwash to prevent chemotherapy-induced stomatitis in patients with breast cancer.
- Author
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Kuba S, Soutome S, Hagiwara Y, Kikawa Y, Iwamoto T, Sangai T, Harao M, Yamaguchi T, Taji T, Igarashi A, Kajimoto Y, Sakurai N, Yamanouchi K, Watanabe K, Maeda N, Suzuki M, Maeda S, Toh U, Ebata A, Iwakuma N, Matsunuma R, Yamaguchi M, and Mukai H
- Subjects
- Humans, Female, Middle Aged, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols adverse effects, Stomatitis chemically induced, Stomatitis prevention & control, Dexamethasone therapeutic use, Dexamethasone administration & dosage, Breast Neoplasms drug therapy, Mouthwashes
- Abstract
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., (© The Author(s) 2024. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
- Published
- 2025
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