UMIN-CTR Clinical Trial

Basic information
Public title	"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.
Acronym	"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.
Scientific Title	"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.
Scientific Title:Acronym	"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.
Region	Japan

Condition
Condition	Renal cell carcinoma, Neuroendcrine tumors of pancreatic,lung and gastrointsitinaltract, Breast cancer
Classification by specialty	Hepato-biliary-pancreatic medicine Pneumology Breast surgery Dental medicine
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	The use of targeted agents in treating cancer has recently increased and has had a significant positive impact on survival. However, targeted anticancer therapies can also cause significant toxicities. Stomatitis is one of the most commonly reported toxicities of targeted agents and can influence patient adherence and treatment outcomes. Prevention is the most important intervention in managing stomatitis induced by anticancer therapy. This study aimed to investigate the causal relationship between the oral microflora and onset of stomatitis and to determine its preventive management.
Basic objectives2	Others
Basic objectives -Others	In this study, "the prophylactic use of hydrocortisone-containing mouthwash in preventing mTOR -inhibitor-associated stomatitis" UMIN ID000025408 (2016.12.28) is included.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The incidence is > Grade 2 stomatitis in 8 weeks.
Key secondary outcomes	Variation of the oral microflora

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine Maneuver
Interventions/Control_1	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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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
Key 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
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Hiroji Middle name Last name Iwata
Organization	Aichi Cancer Center
Division name	Department of Breast Oncology
Zip code	464-8681
Address	1-1 Kanokoden Chikusa-ku, Nagoya, Aichi-pref
TEL	052-762-6111
Email	hiwata@aichi-cc.jp

Public contact
Name of contact person	1st name Michiko Middle name Last name Tatematsu
Organization	Aichi Cancer Center
Division name	Department of Pharmacy
Zip code	464-8681
Address	1-1 Kanokoden Chikusa-ku, Nagoya, Aichi-pref
TEL	052-762-6111
Homepage URL
Email	mtatema0905@gmail.com

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

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Aichi Cancer Center
Address	1-1 Kanokoden Chikusa-ku, Nagoya, Aichi-pref
Tel	052-762-6111
Email	irb@aichi-cc.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	愛知県がんセンター（愛知県）

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	30
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	During data analysis
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 02 Month 15 Day
Date of IRB	2017 Year 02 Month 15 Day
Anticipated trial start date	2017 Year 02 Month 15 Day
Last follow-up date	2017 Year 11 Month 17 Day
Date of closure to data entry	2022 Year 01 Month 10 Day
Date trial data considered complete	2022 Year 01 Month 10 Day
Date analysis concluded	2022 Year 01 Month 10 Day

Other
Other related information

Management information
Registered date	2017 Year 07 Month 06 Day
Last modified on	2022 Year 01 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032119