This is a randomized, multi-center, single-use, active-controlled, two-stage open study of episil®. The purpose of this study is to assess the local analgesic effect of episil® in cancer patients suffering from chemotherapy- and/or radiation-induced oral mucositis, which will provide scientific and reliable clinical data in the product registration in China.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
60
Firmly press the pump and apply the stream of liquid to the oral cavity 3 times (a total volume of 0.45 mL approximately). Distribute to affected areas in the mouth, for example by using the tongue. Wait for 5 minutes for the protective film to form.
Gently pour 5 mL of rinse into the mouth, keep the rinse staying in the oral cavity for at least 1 minute, and spilt out the liquid.
The People's Liberation Army 307 Hospital
Beijing, Beijing Municipality, China
Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Tongji Hospital
Wuhan, Hubei, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Area under the curve (AUC) of pain score of oral mucositis
Oral mucosal pain is assessed by a numerical score (0-10 Likert-pain scale).
Time frame: During 6 hours after a single use of investigational medical device
Pain intensity decrease inside the oral cavity
Oral mucosal pain is assessed by a numerical score (0-10 Likert-pain scale).
Time frame: During 6 hours after a single use of investigational medical device
Peak pain intensity difference inside the oral cavity
Oral mucosal pain is assessed by a numerical score (0-10 Likert-pain scale).
Time frame: During 6 hours after a single use of investigational medical device
Incidence of adverse events
Time frame: 2 days
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The People's Liberation Army 81 Hospital
Nanjing, Jiangsu, China
The First Hospital of Jilin University
Changchun, Jilin, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China