NIPH Clinical Trials Search

UMIN ID: UMIN000028110

Registered date:01/08/2017

"This study on the preventive management of stomatitis due to everolimus treatment with steroid-containing mouthwash" examines the causal relationship between drug metabolizing enzyme and onset of stomatitis.

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedRenal cell carcinoma, Neuroendcrine tumors of pancreatic,lung and gastrointsitinaltract, Breast cancer
Date of first enrollment2017/03/03
Target sample size30
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)When a registered patient visits a dental clinic, the dentist collects oral mucus from the oral mucosal surface using a sterilized swab at days 0, 14, and 28.


Primary OutcomeThe incidence is > Grade 2 stomatitis in 8 weeks.
Secondary OutcomeRelationship between stomatitis and drug metabolizing enzymes

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1.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

Related Information


public contact
Name Michiko Tatematsu
Address 1-1 Kanokoden Chikusa-ku, Nagoya, Aichi-pref Japan
Telephone 052-762-6111
Affiliation Aichi Cancer Center Department of Pharmacy
scientific contact
Name Hiroji Iwata
Address 1-1 Kanokoden Chikusa-ku, Nagoya, Aichi-pref Japan
Telephone 052-762-6111
Affiliation Aichi Cancer Center Department of Breast Oncology