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A randomized phase III study evaluating dexamethasone-based mouthwash to prevent chemotherapy-induced stomatitis in patients with breast cancer.
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.
Afiliação
  • Kuba S; Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki 852-8102, Japan.
  • Soutome S; Department of Oral Health, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki 852-8102, Japan.
  • Hagiwara Y; Department of Biostatistics, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan.
  • Kikawa Y; Department of Breast Surgery, Kansai Medical University Hospital, 3-1 Shinmachi 2 Chome, Hirakata, Osaka 573-1191, Japan.
  • Iwamoto T; Breast and Thyroid Surgery, Kawasaki Medical School Hospital, 577 Matsushima, Kurashiki, Okayama 701-0192, Japan.
  • Sangai T; Department of Breast and Thyroid Surgery, Kitasato University School of Medicine, 1-15-1, Kitazato, Minami-ku, Sagamihara, Kanagawa 252-0375, Japan.
  • Harao M; Department of Breast Oncology, Jichi Medical University, 3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan.
  • Yamaguchi T; Department of Medical Oncology, Toranomon Hospital, 2-2-2 Toranomon, Minato-ku, Tokyo 105-8470, Japan.
  • Taji T; Department of Breast Surgery, Hyogo Prefectural Amagasaki General Medical Center, 17-77, Higashinanba-machi, Amagasaki, Hyogo 660-8550, Japan.
  • Igarashi A; Department of Health Economics and Outcomes Research, Graduate School of Pharmaceutical Sciences, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan.
  • Kajimoto Y; Department of Health Economics and Outcomes Research, Graduate School of Pharmaceutical Sciences, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan.
  • Sakurai N; Cancer Solutions, Inc., Tokyo, Japan.
  • Yamanouchi K; Department of Breast and Endocrine Surgery, Nagasaki Harbor Medical Center, 6-39, Shinchi-machi, Nagasaki 850-8555, Japan.
  • Watanabe K; Department of Medical Oncology, NHO Hokkaido Cancer Center, 1-1, 5-7 Yamanote, Nishi-Ku, Sapporo, Hokkaido 063-0005, Japan.
  • Maeda N; Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine, 1-1-1, MinamiKogushi, Ube, Yamaguchi 755-8505, Japan.
  • Suzuki M; Breast Center, Kitamurayama Hospital, 2-15-1, Onsen-machi, Higashine, Yamagata 999-3792, Japan.
  • Maeda S; Department of Surgery, Nagasaki Rosai Hospital, 12-5, Setogoe 2-chome, Sasebo, Nagasaki 857-0134, Japan.
  • Toh U; Department of Breast Surgery, Kurume University Hospital, 67 Asahi-machi, Kurume, Fukuoka 830-0011, Japan.
  • Ebata A; Department of Breast and Endocrine Surgical Oncology, Tohoku University Graduate School of Medicine, 2-1, Seiryo-machi, Aoba-Ku, Sendai, Miyagi 980-8575, Japan.
  • Iwakuma N; Breast Center, Department of Breast Surgery, NHO Kyushu Medical Center, 1-8-1, Chigyohama, Fukuoka 810-8563, Japan.
  • Matsunuma R; Department of Breast Surgery, Shizuoka General Hospital, 4-27-1, Kita Ando Aoi-ku, Shizuoka 420-8527, Japan.
  • Yamaguchi M; Department of Breast Surgery, JCHO Kurume General Hospital, 21 Kushihara-machi, Kurume, Fukuoka 830-0013, Japan.
  • Mukai H; Department of Breast and Medical Oncology, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, Chiba 277-8577, Japan.
Jpn J Clin Oncol ; 2024 Oct 01.
Article em En | MEDLINE | ID: mdl-39354670
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 11 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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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Idioma: En Ano de publicação: 2024 Tipo de documento: Article
Texto completo
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XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Idioma: En Ano de publicação: 2024 Tipo de documento: Article