UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The exploratory study for the efficacy of rikkunshito on anorexia in the patients with TS-1 treatment
Title of the study (Brief title)	The exploratory study for the efficacy of rikkunshito on anorexia in the patients with TS-1 treatment
Region	Japan

Condition
Condition	Gastric cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy and safety of rikkunshito for anorexia with TS-1 treatment after surgery
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Improvement of anorexia
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	Rikkunshito 7.5 g/day orally in 2 or 3 divided doses before meals for 6 weeks
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	At enrollment 1)The histologically confirmed gastric cancer patients who had received curative surgical procedure The patients adapting all follow criteria "Curability A or B" "No Serious postoperative complication" "ECOG PS grade 0, 1 or 2" 2)Planning TS-1 chemotherapy for postoperative adjuvant chemotherapy 3)The patients with written informed consent For starting test drug administration The patients with anorexia (CTCAE Grade 1 or 2) during TS-1 chemotherapy
Key exclusion criteria	1)Severe complications (liver disorder, kidney disorder, heart disease, blood disease, metabolic disease etc) 2)Synchronous multiple cancer 3)Planning or during other chemotherapy 4)Disorder in liver, gallbladder, or pancreas 5)Gastrointestinal bleeding, mechanical ileus, gastrointestinal perforation 6)Planning or during treatment of investigational drug 7)Pregnant, considering pregnancy or lactation 8) Planning or during treatment of traditional Japanease medicine 9) As determined by the investigator the subject is not adequate to participate
Target sample size	20

Research contact person
Name of lead principal investigator	Koji Yakabi
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Gastroenterology and Hepatology
Address	1981 Kamoda, Kawagoe-shi, SAITAMA
TEL	0049-228-3741
Email	kjyakabi@saitama-med.ac.jp

Public contact
Name of contact person	Koji Yakabi
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Gastroenterology and Hepatology
Address	1981 Kamoda, Kawagoe-shi, SAITAMA
TEL	049-228-3741
Homepage URL
Email	kjyakabi@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical Center, Saitama Medical University
Institute
Department

Funding Source
Organization	TSUMURA & CO.
Organization
Division
Category of Funding Organization	Profit organization
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	2010 Year 02 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2009 Year 12 Month 14 Day
Anticipated trial start date	2010 Year 02 Month 01 Day
Last follow-up date	2012 Year 02 Month 01 Day
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	2010 Year 01 Month 12 Day
Last modified on	2018 Year 02 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003585