Indomethacin oral spray for the analgesic effect of pain reduction in patient with oral mucositis due to cancer therapy: randomized, double-blind, placebo-controlled phase II trial

INTERVENTION: IOS(0.8mg)is orally adminstered by spray after lunch.4hours later, IOS is administered before each meal and when pain appears.Treatment ends after 24hours from the initiation. Placebo(0.8mg)is orally adminstered by spray after lunch.4hours later, IOS is administered before each meal and when pain appears.Treatment ends after 24hours from the initiation. CONDITION: Patients with oral mucisitis due to cancer therapy PRIMARY OUTCOME: Brief Pain Inventry(BPI)‐ item6 change between before(0min) and after IOS treatment(30min). SECONDARY OUTCOME: 1)Area Under the Curve of BPI‐item6 after IOS teatment(0min,15min,60min,120min,180min and 240min) ; 2)BPI (item3,4,5,6,8) cange between before(0min) and after IOS treatment(24hours) ; 3)Global impression; 4)Minimal clinically important difference; 5)Adverse effect INCLUSION CRITERIA: 1)Able to give written informed consent 2)Patients aged 20 or above at the time of obtaining informed consent 3)Histologically confirmed diagnosis of cancer 4)Hospitalized patients with oral mucositis due to chemotherapy and/or radiotherapy 5)Patients with oral mucositis CTCAE(Ver. 4) Grade <=3 and received oral care 6)Patients with oral mucositis pain(BPI item5) >=4 7)Patients with expected survival of 1month or longer 8)Patients who can take oral drugs