"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.

"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. - "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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000028110

Enrollment

Registered

2017-08-01

Start date

2017-03-03

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal cell carcinoma, Neuroendcrine tumors of pancreatic,lung and gastrointsitinaltract, Breast cancer

Interventions

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.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Pathologically confirmed, well differentiated (G1 or G2), advanced (unresectable or metastatic), neuroendocrine tumor of Pancreus, GI or lung origin 2.Pathologically confirmed advanced or metastatic renal cell carcinoma 3.Pathologically confirmed advanced or metastatic ER-positive and HER2-negatice breast cancer 4.ECOG performance status 0 or 1 5.Adequate bone marrow, liver and renal function 6.Informed consent is obtainable from the subject herself in documented form using the Consent Form

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The incidence is > Grade 2 stomatitis in 8 weeks.	—

Secondary

Measure	Time frame
Relationship between stomatitis and drug metabolizing enzymes	—

Countries

Japan

Contacts

Public ContactMichiko Tatematsu

Aichi Cancer Center Department of Pharmacy

mtatema@aichi-cc.jp052-762-6111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026

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