UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Parallel competitive study in two groups to examine the effects of Kampo Medicines (oren-to) for oral mucositis in patients receiving radiation therapy
Title of the study (Brief title)	Effects of Kampo Medicines (oren-to) for oral mucositis in patients receiving radiation therapy
Region	Japan

Condition
Condition	mucositis in patients receiving radiation therapy
Classification by specialty	Oto-rhino-laryngology Radiology Anesthesiology Oral surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We evaluate the effectiveness of Kampo Medicines (oren-to) for oral mucositis in patients receiving radiation therapy for head and neck cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Maximum Grade in severity score for oral mucositis :NCI-CTC/CTCAE V4
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Oren-to and standard therapy for oral mucositis
Interventions/Control_2	Standard therapy for oral mucositis only
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	Patients receiving radiation therapy (60Gy) combined with anti-cancer medication (cisplatin) for head and neck cancer (oral, oro- and hypo-pharyngeal cancer)
Key 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
Target sample size	30

Research contact person
Name of lead principal investigator	Takao NAMIKI
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Japanese-Oriental (Kampo) Medicine
Address	1-8-1 Inohana Chuo-ku, Chiba City
TEL	+81-43-226-2984
Email	tnamiki@faculty.chiba-u.jp

Public contact
Name of contact person	Takao NAMIKI
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Japanese-Oriental (Kampo) Medicine
Address	1-8-1 Inohana Chuo-ku, Chiba City
TEL	+81-43-226-2984
Homepage URL
Email	tnamiki@faculty.chiba-u.jp

Sponsor
Institute	Department of Japanese-Oriental (Kampo) Medicine,Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 23 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 09 Month 19 Day
Anticipated trial start date	2017 Year 11 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 11 Month 23 Day
Last modified on	2018 Year 01 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033903