臨床研究等提出・公開システム

Scientific Title	Parallel competitive study in two groups to examine the effects of Kampo Medicines (oren-to) for oral mucositis in patients receiving radiation therapy (Effects of Kampo Medicines (oren-to) for oral mucositis in patients receiving radiation)
Public Title	Effects of Kampo Medicines (oren-to) for oral mucositis in patients receiving radiation therapy (Effects of oren-to for oral mucositis in patients receiving radiation therapy)

Contact for Scientific Queries	Name	Namiki Takao
	Affiliation	Chiba University Hospital
	Address	1-8-1 Inohana Chuo-ku, Chiba City, Japan
	Telephone	+81-43-226-2984
	E-mail	tnamiki@faculty.chiba-u.jp
Contact for Public Queries	Name	Namiki Takao
	Affiliation	Medical Mycology Research Center, Chiba University
	Address	1-8-1 Inohana Chuo-ku, Chiba City, Japan
	Telephone	+81-43-222-7171
	E-mail	tnamiki@faculty.chiba-u.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Sept. 19, 2017
Actual date of first enrollment		Nov. 30, 2017
Target sample size		30
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients receiving radiation therapy (60Gy) combined with anti-cancer medication (cisplatin) for head and neck cancer (oral, oro- and hypo-pharyngeal cancer)
	Exclusion Criteria	1. Patient who cannot take Kampo medications at start of this research 2. Patient with allergy for oren-to 3. Patient who is judged to be inappropriate to carry out the research safely by the principal or sub investigator
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		oral mucositis
Intervention(s)		medication
Health Condition(s) Keyword		Radiation therapy, anticancer drugs
Intervention(s) Keyword
Health Condition(s) Code		D013280
Intervention(s) Code
Primary Outcome(s)		Maximum Grade in severity score for oral mucositis :NCI-CTC/CTCAE V4
Secondary Outcome(s)		Performance status (PS: ECOG), period of Grade 2 or higher, period of Grade 3 or higher, hospitalization, opioid usage, period from the end of radiation treatment to the start of oral intake

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Certified Clinical Research Review Board, Chiba University
Address	1-8-1 Inohana Chuo-ku, Chiba-City, Japan, Chiba
Telephone	+81-43-226-2616
E-Mail	prc-jim@chiba-u.jp
Approval Status	Approval
Date of approval

Secondary ID(s)	UMIN000030091
Issuing Authority	University Hospital Medical Information Network

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history