UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Preventive effect of rebamipide on chemotherapy-induced oral mucositis in cancer patients
Title of the study (Brief title)	Preventive effect of rebamipide on oral mucositis
Region	Japan

Condition
Condition	oral mucositis
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify a preventive effect of rebamipide on chemotherapy-induced oral mucositis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	incidence of oral mucositis
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	no treatment
Interventions/Control_2	treatment 1 with rebamipide
Interventions/Control_3	treatment 2 with rebamipide
Interventions/Control_4	treatment 3 with rebamipide
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. Cancer patients who will be treated with chemotherapy 2. Patients who can take rebamipide 3. Patients with written informed consent
Key exclusion criteria	1. Patients treated with rebamipide 2. Patients with oral mucositis 3. Patients who will be treated with radiation on head and neck within the study period 4. Patients with allergy history for rebamipide
Target sample size	40

Research contact person
Name of lead principal investigator	Kohji Naora
Organization	Shimane University Hospital
Division name	Department of Pharmacy
Address	89-1, Enya-cho, Izumo, Japan
TEL	0853-23-2111
Email	knaora@med.shimane-u.ac.jp

Public contact
Name of contact person	Kohji Naora
Organization	Shimane University Hospital
Division name	Department of Pharmacy
Address	89-1, Enya-cho, Izumo, Japan
TEL	0853-23-2111
Homepage URL
Email	knaora@med.shimane-u.ac.jp

Sponsor
Institute	Shimane University Hospital
Institute
Department

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

Other related organizations
Co-sponsor	Shimane Prefectural Central Hospital
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	島根大学医学部附属病院、島根県立中央病院

Other administrative information
Date of disclosure of the study information	2010 Year 12 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 08 Month 01 Day
Anticipated trial start date	2008 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 12 Month 21 Day
Last modified on	2017 Year 06 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005673