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 |
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Health condition(s) or Problem(s) studied | Renal cell carcinoma, Neuroendcrine tumors of pancreatic,lung and gastrointsitinaltract, Breast cancer |
Date of first enrollment | 2017/03/03 |
Target sample size | 30 |
Countries of recruitment | Japan |
Study type | Interventional |
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. |
Outcome(s)
Primary Outcome | The incidence is > Grade 2 stomatitis in 8 weeks. |
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Secondary Outcome | Relationship between stomatitis and drug metabolizing enzymes |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | Not applicable |
Gender | Male and Female |
Include criteria | |
Exclude criteria | 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 |
Related Information
Primary Sponsor | Department of Head and Neck Surgery, Pharmacy,Aichi cancer center Faculty of Pharmaceutical Sciences Suzuka University of MedicalScience Faculty of Bioscience and Bioindustry,Tokushima University |
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Secondary Sponsor | |
Source(s) of Monetary Support | none |
Secondary ID(s) |
Contact
public contact | |
Name | Michiko Tatematsu |
Address | 1-1 Kanokoden Chikusa-ku, Nagoya, Aichi-pref Japan |
Telephone | 052-762-6111 |
mtatema@aichi-cc.jp | |
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 |
hiwata@aichi-cc.jp | |
Affiliation | Aichi Cancer Center Department of Breast Oncology |