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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025408
Receipt No. R000029251
Scientific Title Prophylactic use of hydrocortisone containing mouthwash in the prevention of mTOR inhibitor-associated stomatitis
Date of disclosure of the study information 2016/12/28
Last modified on 2018/01/11

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Basic information
Public title Prophylactic use of hydrocortisone containing mouthwash in the prevention of mTOR inhibitor-associated stomatitis
Acronym Prophylactic use of hydrocortisone containing mouthwash in the prevention of mTOR inhibitor-associated stomatitis
Scientific Title Prophylactic use of hydrocortisone containing mouthwash in the prevention of mTOR inhibitor-associated stomatitis
Scientific Title:Acronym Prophylactic use of hydrocortisone containing mouthwash in the prevention of mTOR inhibitor-associated stomatitis
Region
Japan

Condition
Condition Renal cell carcinoma, Neuroendcrine tumors of pancreatic,lung and gastrointsitinaltract, Breast cancer
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Pneumology
Breast surgery Urology Dental medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The use of targeted agents in the treatment of cancer has recently exploded 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 impact on patient adherence and treatment outcomes. Prevention is most important intervention in the management of stomatitis induced by anticancer therapy, but there are no evidence-based methods for the prevention of stomatitis associated with targeted therapies.In this study, our aim is to establish the effective prevention of oral stomatitis associated with targeted anticancer therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes The incidence of greater than or equal to Grade2 stomatitis in 8 weeks
Key secondary outcomes Safety of hydrocortisone containing mouthwash adjusted by the drugs approved in Japan. The incidence of stomatitis according to the tumor subtype. The site of stomatitis. The duration and severity of stomatitis

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification NO
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Patients are instructed to swish and expectorate new steroid-containing mouthwash 4 times daily.
Treatment with new steroid-containing mouthwash start on Day 1 of everolimus -based therapy.
Intervention period:8weeks
New steroid-containing mouthwash is composed by diphenhydramine, hydrocortisone, nystatin and tetracycline.
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
Middle name
Last name Hiroji Iwata
Organization Aichi Cancer Center
Division name Department of Breast Oncology
Zip code
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
Middle name
Last name Masaya Hattori
Organization Aichi Cancer Center
Division name Department of Breast Oncology
Zip code
Address 1-1 Kanokoden Chikusa-ku, Nagoya, Aichi-pref
TEL 052-762-6111
Homepage URL
Email mhattori@aichi-cc.jp

Sponsor
Institute Aichi Cnacer Center
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Gastroenterology, Aichi cancer center
Department of Clinical Oncology, Aichi cancer center
Department of Thoracic Oncology, Aichi cancer center
Department of Head and Neck Surgery, Aichi cancer center
Department of Pharmacy, Aichi cancer center
Faculty of Bioscience and Bioindustry, Tokushima University
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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中央病院(愛知県)

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 28 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
Results
Results date posted
Results Delayed
Results Delay Reason
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 Completed
Date of protocol fixation
2016 Year 11 Month 22 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 14 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
2016 Year 12 Month 26 Day
Last modified on
2018 Year 01 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029251

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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