臨床研究等提出・公開システム

Scientific Title	Randomized study on the effect of oral health care on cough reflex and immunoreaction to operative patients with lung cancer (Oral health care for lung cancer patients)
Public Title	Randomized study on the effect of oral health care on cough reflex and immunoreaction to operative patients with cancer

Contact for Scientific Queries	Investigator Name	Hiroshi UEMATSU
	Investigator Organization	Tokyo Medical and Dental University
	Address	113-8549 Yushima1-5-45 Bunkyou - ku, Tokyo
	TEL	+81-3-5803-5559
	E-mail
Contact for Public Queries	Contact Name	Hiroshi UEMATSU,DDS,PhD
	Contact Organization	Tokyo Medical and Dental University
	Address	113-8549 Yushima1-5-45 Bunkyou - ku, Tokyo
	TEL	+81-3-5803-5559
	E-mail	matsu.gerd@tmd.ac.jp

Recruitment Status	TEMPORARILY CLOSED

Date of First Enrollment		April. 01, 2011
Planned Number of Subjects		190
Nature of Investigation		Interventional
Study Design	Description of Trial Design	Randomized controlled trial
	Type of Control
	Trial Blinding Schema	open(masking not used)
	Randomized	Yes
Trial Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	Signed and dated informed consent
	Exclusion Criteria	Asthma Patient
	Minimum Age	No limit
	Maximum Age	No limit
	Sex of Participants	Both
Trial Indication(s)		The lung cancer patients who schedules an operation
Intervention(s)		Intervention type:PROCEDURE Name of intervention:Oral health care Dose form / Japanese Medical Device Nomenclature:NOT APPLICABLE Route of administration / Site of application:NOT APPLICABLE Dose per administration: Dosing frequency / Frequency of use: Planned duration of intervention: Intended dose regimen: detailes of teratment arms: Comparative intervention name:Placebo Dose form / Japanese Medical Device Nomenclature: Route of administration / Site of application: Dose per administration: Dosing frequency / Frequency of use: Planned duration of intervention: Intended dose regimen:
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Infectious complication
Secondary Outcome(s)		NK cell activity and Cough reflex

Primary Sponsor	Hiroshi UEMATSU
Secondary Sponsor	Kanji NAGAI National Cancer Center Hospital East Mitsuyo NISHIMURA National Cancer Center Hospital East Jyunji YOSHIDA National Cancer Center Hospital East Chiharu YAMADA Tokyo Medical and Dental University Chieko KUBOTA Tokyo Medical and Dental University

Sources of funding	Tokyo Medical and Dental University

Name of Ethics Committee
Address
TEL
FAX
E-Mail
Ethics Committee Website
Committee Approval Number
Approved by Ethics Committee	Yes
Reason for Unapproval

Date of approved

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Secondary Study ID	JMA-IIA00057
Issuer Name

Countrie(s) of Recruitment	Japan

History of Changes

No	Publication date
2	Oct. 14, 2014	(this page)	Changes
1	Mar. 16, 2011	Detail

List of change history