Dexamethasone-based mouthwash may improve post chemotherapy stomatitis in breast cancer patients

No standard approach other than oral care is available to prevent chemotherapy-induced stomatitis in breast cancer patients. In this randomized, controlled phase 2 trial, we aimed to assess the efficacy and safety of a dexamethasone-based mouthwash in preventing chemotherapy-induced stomatitis in patients with early breast cancer.

Patients with breast cancer scheduled for epirubicin and cyclophosphamide (EC) or docetaxel and cyclophosphamide (TC) therapy were selected and allocated in a 1:1 ratio to the intervention and control groups. The intervention group received chemotherapy, oral care, and a dexamethasone-based mouthwash, whereas the control group received chemotherapy and oral care. The primary endpoint was the incidence of stomatitis. This was a phase 2 study, and the significance level for the analysis of the primary endpoint was set a priori at 0.2.

Main findings

Data pertaining to 58 patients in the control group and 59 patients in the intervention group were analyzed. Stomatitis incidence was 55% and 38% in the control and intervention groups, respectively (risk ratio, 0.68; 80% confidence interval, 0.52-0.88; P = .052). Stomatitis severity was lower in the intervention group than in the control group (P = .03). The proportion of patients who adhered to the mouthwash regimen was 87% (interquartile range, 67.8%-95.3%). No severe oral infections were observed.

Principal conclusions

The dexamethasone-based mouthwash safely reduced stomatitis incidence and severity in patients receiving chemotherapy for early breast cancer. Phase 3 clinical trials are warranted for validating our results.

Keywords: Dexamethasone-based mouthwash; Chemotherapy; Stomatitis; Breast cancer; Randomized phase 2 study

Reference:

Sayaka Kuba, Shigeto Maeda, Kenichiro Shibata, Sakiko Soutome, Kosho Yamanouchi, Megumi Matsumoto, Aya Tanaka, Michi Morita, Toshiko Hatachi, Ryota Otsubo, Hiroshi

Yano, Yumiko Kawashita, Shuntaro Sato, Hideki Taniguchi, Kengo Kanetaka, Masahiro Umeda, Takeshi Nagayasu, Susumu Eguchi, EFFICACY AND SAFETY OF A DEXAMETHASONE-BASED MOUTHWASH TO PREVENT CHEMOTHERAPY-INDUCED STOMATITIS IN WOMEN WITH BREAST CANCER: A MULTICENTRE, OPEN-LABEL, RANDOMISED PHASE 2 STUDY, Journal of Evidence-Based Dental Practice,

2023, 101896, ISSN 1532-3382, https://doi.org/10.1016/j.jebdp.2023.101896.

(https://www.sciencedirect.com/science/article/pii/S1532338223000817)

Keywords:

Dexamethasone-based, mouthwash, may, improve, post, chemotherapy stomatitis, breast, cancer, patient, Sayaka Kuba, Shigeto Maeda, Kenichiro Shibata, Sakiko Soutome, Kosho Yamanouchi, Megumi Matsumoto, Aya Tanaka, Michi Morita, Toshiko Hatachi, Ryota Otsubo, Hiroshi Yano, Yumiko Kawashita, Shuntaro Sato, Hideki Taniguchi, Kengo Kanetaka, Masahiro Umeda, Takeshi Nagayasu, Susumu Eguchi