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

被引：0

作者：

Kuba, Sayaka ^{[1
]}

Soutome, Sakiko ^{[2
]}

Hagiwara, Yasuhiro ^{[3
]}

Kikawa, Yuichiro ^{[4
]}

Iwamoto, Takayuki ^{[5
]}

Sangai, Takafumi ^{[6
]}

Harao, Michiko ^{[7
]}

Yamaguchi, Takeshi ^{[8
]}

Taji, Tomoe ^{[9
]}

Igarashi, Ataru ^{[10
]}

Kajimoto, Yusuke ^{[10
]}

Sakurai, Naomi ^{[11
]}

Yamanouchi, Kosho ^{[12
]}

Watanabe, Kenichi ^{[13
]}

Maeda, Noriko ^{[14
]}

Suzuki, Masahiko ^{[15
]}

Maeda, Shigeto ^{[16
]}

Toh, Uhi ^{[17
]}

Ebata, Akiko ^{[18
]}

Iwakuma, Nobutaka ^{[19
]}

Matsunuma, Ryoichi ^{[20
]}

Yamaguchi, Miki ^{[21
]}

Mukai, Hirofumi ^{[22
]}

机构：

[1] Nagasaki Univ, Grad Sch Biomed Sci, Dept Surg, 1-7-1 Sakamoto, Nagasaki 8528102, Japan

[2] Nagasaki Univ, Grad Sch Biomed Sci, Dept Oral Hlth, 1-7-1 Sakamoto, Nagasaki 8528102, Japan

[3] Univ Tokyo, Grad Sch Med, Dept Biostat, 7-3-1 Hongo,Bunkyo Ku, Tokyo 1130033, Japan

[4] Kansai Med Univ Hosp, Dept Breast Surg, 3-1 Shinmachi 2 Chome, Hirakata, Osaka 5731191, Japan

[5] Kawasaki Med Sch Hosp, Breast & Thyroid Surg, 577 Matsushima, Kurashiki, Okayama 7010192, Japan

[6] Kitasato Univ, Sch Med, Dept Breast & Thyroid Surg, 1-15-1,Kitazato,Minami Ku, Sagamihara, Kanagawa 2520375, Japan

[7] Jichi Med Univ, Dept Breast Oncol, 3311-1 Yakushiji, Shimotsuke, Tochigi 3290498, Japan

[8] Toranomon Gen Hosp, Dept Med Oncol, 2-2-2 Toranomon,Minato Ku, Tokyo 1058470, Japan

[9] Hyogo Prefectural Amagasaki Gen Med Ctr, Dept Breast Surg, 17-77 Higashinanba Machi, Amagasaki, Hyogo 6608550, Japan

[10] Univ Tokyo, Grad Sch Pharmaceut Sci, Dept Hlth Econ & Outcomes Res, 7-3-1 Hongo,Bunkyo Ku, Tokyo 1130033, Japan

[11] Canc Solut Inc, Tokyo, Japan

[12] Nagasaki Harbor Med Ctr, Dept Breast & Endocrine Surg, 6-39 Shinchi Machi, Nagasaki 8508555, Japan

[13] NHO Hokkaido Canc Ctr, Dept Med Oncol, 1-1,5-7 Yamanote,Nishi Ku, Sapporo, Hokkaido 0630005, Japan

[14] Yamaguchi Univ, Grad Sch Med, Dept Gastroenterol Breast & Endocrine Surg, 1-1-1, MinamiKogushi, Ube, Yamaguchi 7558505, Japan

[15] Kitamurayama Hosp, Breast Ctr, 2-15-1,Onsen Machi, Yamagata 9993792, Japan

[16] Nagasaki Rosai Hosp, Dept Surg, 12-5,Setogoe 2 Chome, Sasebo, Nagasaki 8570134, Japan

[17] Kurume Univ Hosp, Dept Breast Surg, 67 Asahi Machi, Kurume, Fukuoka 8300011, Japan

[18] Tohoku Univ, Grad Sch Med, Dept Breast & Endocrine Surg Oncol, 2-1,Seiryo Machi,Aoba Ku, Sendai, Miyagi 9808575, Japan

[19] NHO Kyushu Med Ctr, Breast Ctr, Dept Breast Surg, 1-8-1 Chigyohama, Fukuoka 8108563, Japan

[20] Shizuoka Prefectural Gen Hosp, Dept Breast Surg, 4-27-1,Kita Ando Aoi Ku, Shizuoka 4208527, Japan

[21] JCHO Kurume Gen Hosp, Dept Breast Surg, 21 Kushihara Machi, Kurume, Fukuoka 8300013, Japan

[22] Natl Canc Ctr Hosp East, Dept Breast & Med Oncol, 6-5-1 Kashiwanoha, Kashiwa, Chiba 2778577, Japan

来源：

JAPANESE JOURNAL OF CLINICAL ONCOLOGY | 2024年

关键词：

stomatitis; chemotherapy; dexamethasone mouthwash; randomized controlled phase III trial; CYCLOPHOSPHAMIDE; EPIRUBICIN; DOCETAXEL; WOMEN;

D O I：

10.1093/jjco/hyae136

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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. This randomized controlled phase III trial aims to evaluate the efficacy and safety of a dexamethasone-based mouthwash for preventing chemotherapy-induced stomatitis in patients with early breast cancer.

引用

页码：172 / 175

页数：6

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