UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prophylactic use of hydrocortisone containing mouthwash in the prevention of mTOR inhibitor-associated stomatitis
Title of the study (Brief title)	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	Hiroji Iwata
Organization	Aichi Cancer Center
Division name	Department of Breast Oncology
Address	1-1 Kanokoden Chikusa-ku, Nagoya, Aichi-pref
TEL	052-762-6111
Email	hiwata@aichi-cc.jp

Public contact
Name of contact person	Masaya Hattori
Organization	Aichi Cancer Center
Division name	Department of Breast Oncology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000029251