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Clinical Trials/JPRN-UMIN000028106
JPRN-UMIN000028106
Completed
未知

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

Department of Pharmacy,Aichi cancer center Faculty of Bioscience and Bioindustry,Tokushima University0 sites30 target enrollmentAugust 1, 2017

Overview

Phase
未知
Intervention
Not specified
Conditions
Renal cell carcinoma, Neuroendcrine tumors of pancreatic,lung and gastrointsitinaltract, Breast cancer
Sponsor
Department of Pharmacy,Aichi cancer center Faculty of Bioscience and Bioindustry,Tokushima University
Enrollment
30
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 1, 2017
End Date
November 17, 2017
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Department of Pharmacy,Aichi cancer center Faculty of Bioscience and Bioindustry,Tokushima University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion 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

Outcomes

Primary Outcomes

Not specified

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