by Kazuhiro Omori, Kohei Furukawa, Masatoshi Usubuchi, Tomofumi Hamada, Tadahiko Shien, Michihiro Yoshida, Yuki Nakatsuka, Katsuyuki Hotta, Soichiro Ibaragi, Shogo Takashiba Oral mucositis is a frequent and debilitating adverse event observed in patients undergoing chemotherapy or radiotherapy. Current management strategies are limited in duration, require frequent application, and fail to address the mechanical irritation from teeth.
A novel device, Soft Protector CPC, was developed to overcome these limitations. This multicenter, randomized, two-arm, open-label, confirmatory trial aims to evaluate the efficacy and safety of Soft Protector CPC in patients with breast cancer undergoing chemotherapy.
A total of 154 participants will be randomly assigned in a 1:1 ratio to receive either oral care with Soft Protector CPC or oral care alone. The primary endpoint will be oral mucositis as assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 during the comparative treatment period.
PLOS ONE (Medicine) published a clinical update in Research Highlights on 04 Jun 2026.
The item focuses on A multicenter, randomized, parallel-group confirmatory study protocol to evaluate the efficacy of Soft Protector CPC, a novel oral mucosal protectant, in preventing oral mucositis and alleviating pain in patients with breast cancer.
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