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

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; CSPOR-BC

doi:10.1093/jjco/hyae136

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

Jpn J Clin Oncol. 2025 Feb 4;55(2):172-175. doi: 10.1093/jjco/hyae136.

Authors

Sayaka Kuba¹, Sakiko Soutome², Yasuhiro Hagiwara³, Yuichiro Kikawa⁴, Takayuki Iwamoto⁵, Takafumi Sangai⁶, Michiko Harao⁷, Takeshi Yamaguchi⁸, Tomoe Taji⁹, Ataru Igarashi¹⁰, Yusuke Kajimoto¹⁰, Naomi Sakurai¹¹, Kosho Yamanouchi¹², Kenichi Watanabe¹³, Noriko Maeda¹⁴, Masahiko Suzuki¹⁵, Shigeto Maeda¹⁶, Uhi Toh¹⁷, Akiko Ebata¹⁸, Nobutaka Iwakuma¹⁹, Ryoichi Matsunuma²⁰, Miki Yamaguchi²¹, Hirofumi Mukai²²; CSPOR-BC

Collaborator

CSPOR-BC:
Sayaka Kuba

Affiliations

¹ Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki 852-8102, Japan.
² Department of Oral Health, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki 852-8102, Japan.
³ Department of Biostatistics, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan.
⁴ Department of Breast Surgery, Kansai Medical University Hospital, 3-1 Shinmachi 2 Chome, Hirakata, Osaka 573-1191, Japan.
⁵ Breast and Thyroid Surgery, Kawasaki Medical School Hospital, 577 Matsushima, Kurashiki, Okayama 701-0192, Japan.
⁶ Department of Breast and Thyroid Surgery, Kitasato University School of Medicine, 1-15-1, Kitazato, Minami-ku, Sagamihara, Kanagawa 252-0375, Japan.
⁷ Department of Breast Oncology, Jichi Medical University, 3311-1 Yakushiji, Shimotsuke, Tochigi 329-0498, Japan.
⁸ Department of Medical Oncology, Toranomon Hospital, 2-2-2 Toranomon, Minato-ku, Tokyo 105-8470, Japan.
⁹ Department of Breast Surgery, Hyogo Prefectural Amagasaki General Medical Center, 17-77, Higashinanba-machi, Amagasaki, Hyogo 660-8550, Japan.
¹⁰ 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.
¹¹ Cancer Solutions, Inc., Tokyo, Japan.
¹² Department of Breast and Endocrine Surgery, Nagasaki Harbor Medical Center, 6-39, Shinchi-machi, Nagasaki 850-8555, Japan.
¹³ Department of Medical Oncology, NHO Hokkaido Cancer Center, 1-1, 5-7 Yamanote, Nishi-Ku, Sapporo, Hokkaido 063-0005, Japan.
¹⁴ Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine, 1-1-1, MinamiKogushi, Ube, Yamaguchi 755-8505, Japan.
¹⁵ Breast Center, Kitamurayama Hospital, 2-15-1, Onsen-machi, Higashine, Yamagata 999-3792, Japan.
¹⁶ Department of Surgery, Nagasaki Rosai Hospital, 12-5, Setogoe 2-chome, Sasebo, Nagasaki 857-0134, Japan.
¹⁷ Department of Breast Surgery, Kurume University Hospital, 67 Asahi-machi, Kurume, Fukuoka 830-0011, Japan.
¹⁸ Department of Breast and Endocrine Surgical Oncology, Tohoku University Graduate School of Medicine, 2-1, Seiryo-machi, Aoba-Ku, Sendai, Miyagi 980-8575, Japan.
¹⁹ Breast Center, Department of Breast Surgery, NHO Kyushu Medical Center, 1-8-1, Chigyohama, Fukuoka 810-8563, Japan.
²⁰ Department of Breast Surgery, Shizuoka General Hospital, 4-27-1, Kita Ando Aoi-ku, Shizuoka 420-8527, Japan.
²¹ Department of Breast Surgery, JCHO Kurume General Hospital, 21 Kushihara-machi, Kurume, Fukuoka 830-0013, Japan.
²² Department of Breast and Medical Oncology, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, Chiba 277-8577, Japan.

PMID: 39354670
DOI: 10.1093/jjco/hyae136

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.

Keywords: chemotherapy; dexamethasone mouthwash; randomized controlled phase III trial; stomatitis.

Publication types

Randomized Controlled Trial
Clinical Trial, Phase III
Multicenter Study

MeSH terms

Adult
Breast Neoplasms* / drug therapy
Clinical Trials, Phase III as Topic
Dexamethasone* / administration & dosage
Dexamethasone* / therapeutic use
Female
Humans
Middle Aged
Mouthwashes* / therapeutic use
Stomatitis* / chemically induced
Stomatitis* / prevention & control

Substances

Dexamethasone
Mouthwashes

Grants and funding

JP21km0908001/AMED