UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Preventive effect of Kampo medicine (Hangeshashin-to) plus Minocycline against afatinib-induced diarrhea, mucositis oral and rash acneiform in patients with non-small cell lung cancer:Multicenter Phase II study
Title of the study (Brief title)	Preventive effect of Kampo medicine (Hangeshashin-to) plus Minocycline against afatinib-induced diarrhea, mucositis oral and rash acneiform in patients with non-small cell lung cancer
Region	Japan

Condition
Condition	EGFR mutation-positive non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To prove the validity of Hangeshashin-to plus minocycline for diaffhes mucositis oral and rash acneiform by Afatinib
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	In 4 weeks time severe diarrhea(onset of Grade 3 or 48 hours or more of Grade 2 of diarrhea) expression rate by Afatinib
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Hangeshashin-to and Minocycline
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) Adequate organ function 2) Histologically or cytologically confirmed EGFR mutation-positive non-small cell lung cancer 3) Afatinib has not been administered in the past 4) 20 years or older 5) Estimated life expectancy at least 3 months 6)Performance Status (ECOG) 0-2 7)With written informed consent
Key exclusion criteria	1) over Grade 2 of diarrhea, a severe gastrointestinal disorder 2)over Grade 2 of skinl disorder 3)over Grade 2 of mucositis 4)Interstitial lung disease 5) aldosteronism 6) myopathy 7) hypokalemia 8) uncontrolled complications 9) No pregnancy, during nursing 10) infection of HBV, HCV, and HIV 11). History of sensitivity of Afatinb, Hangeshashin-to and tetracycline antibiotic 12)In addition, the primary doctor judging inappropriate for entry
Target sample size	28

Research contact person
Name of lead principal investigator	Masao Ichiki
Organization	National Hospital Organization Kyushu Medical Center
Division name	Department of Respiratory Medicine
Address	1-8-1 Jigyohama Chuo-ku, Fukuoka 810-8563, Japan
TEL	092-852-0700
Email	ichiki@kyumed.jp

Public contact
Name of contact person	Masao Ichiki
Organization	National Hospital Organization Kyushu Medical Center
Division name	Department of Respiratory Medicine
Address	1-8-1 Jigyohama Chuo-ku, Fukuoka 810-8563, Japan
TEL	092-852-0700
Homepage URL
Email	ichiki@kyumed.jp

Sponsor
Institute	National Hospital Organization Kyushu Medical Center Department of Respiratory Medicine
Institute
Department

Funding Source
Organization	National Hospital Organization Kyushu Medical Center
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	2015 Year 07 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 30 Day
Anticipated trial start date	2015 Year 07 Month 27 Day
Last follow-up date	2017 Year 06 Month 01 Day
Date of closure to data entry	2017 Year 06 Month 01 Day
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	2015 Year 07 Month 23 Day
Last modified on	2017 Year 04 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021298