Prophylactic use of hydrocortisone containing mouthwash in the prevention of mTOR inhibitor-associated stomatitis - Prophylactic use of hydrocortisone containing mouthwash in the prevention of mTOR inhibitor-associated stomatitis

Aichi Cnacer Center0 sites30 target enrollmentDecember 28, 2016

Overview

No summary available.

Registry

who.int

Start Date

December 28, 2016

End Date

November 17, 2017

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Aichi Cnacer Center

•1\.Occurrence of oral mucositis within 1 month prior to randomization 2\.Previous mTOR inhibitor treatment (everolimus, etc.) 3\.Interstitial pneumonia or pulmonary fibrosis 4\.Received drug treatment known to have a strong inhibitory or inductive effect on the cytochrome P450 (CYP) 3A isozymes (rifabutin, rifampicin, clarithromycin, ketoconazole, itraconazole, voriconazole, ritonavir, telithromycin) 5\.Detection level of HBV\-DNA 6\.HCV infection or a history of HCV infection 7\.History of hypersensitivity to a protocol treatment drug or a vehicle in the drug preparation 8\.Multiple active cancers (homochronous multiple cancers, or heterochronous multiple cancers with a cancer\-free period of less than 5 years prior to randomization) Carcinoma in situ deemed to be cured by local treatment (lesions that are intraepithelial carcinoma or mucosal cancer) is not included as an active multiple cancer 9\.Brain metastasis that requires treatment for intracranial hypertension or emergency irradiation of the brain 10\.Pleural effusion, ascites, or pericardial effusion that requires emergency treatment 11\.Concurrent and active infectious disease 12\.With uncontrolled diabetes mellitus or currently receiving insulin therapy 13\.Difficulty to participate in this study due to mental illness or psychiatric symptoms 14\.With another reasons recognized as inadequate to participate in this study by doctors