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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028106
Receipt No. R000032119
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.
Date of disclosure of the study information 2017/08/01
Last modified on 2019/07/08

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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 mtatema@aichi-cc.jp

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 No longer recruiting
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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 06 Day
Last modified on
2019 Year 07 Month 08 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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