UMIN-CTR Clinical Trial

Basic information
Public title	A pilot study to plan a protocol for the clinical trial evaluating the efficacy of Rikkunshito for patients after total gastrectomy
Acronym	A pilot study to evaluate the efficacy of Rikkunshito for patients after total gastrectomy
Scientific Title	A pilot study to plan a protocol for the clinical trial evaluating the efficacy of Rikkunshito for patients after total gastrectomy
Scientific Title:Acronym	A pilot study to evaluate the efficacy of Rikkunshito for patients after total gastrectomy
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study is to establish the most suitable protocol for a clinical trial to evaluate the effect of early administration of Rikkunshito on weight loss, decreased appetite and reduced quality of life after total gastrectomy in patients with gastric cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Weight loss at three months after surgery
Key secondary outcomes	Medication compliance of Rikkunshito Adverse events associated with Rikkunshito Quality of life score Plasma glucagon-like peptide-1

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Oral administration of Rikkunshito 7.5g per day for 84 days from post operative day three.
Interventions/Control_2	No oral administration of Rikkunshito perioperatively.
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	1. Histological proven adenocarcinoma of stomach 2. cT1-T4a and no distant metastasis 3. R0 resection with total gastrectomy 4. Age 20-80 years 5. Eastern Cooperative Oncology Group performance status 0-1 6. Normal function of organ systems 7. Written informed consent
Key exclusion criteria	1. Synchronous or metachronous cancer 2. Reduced oral intake 3. Past gastrointestinal surgery 4. Preoperative chemotherapy 5. Administration of Rikkunshito ingredients before surgery 6. Unstable angina or myocardial infarction within six months 7. Pulmonary disease treated with continuous oxygen 8. Hemorrhagic tendency 9. Diabetes mellitus 10. Systemic treatment with corticosteroids 11. Pregnancy, breast-feeding, or contemplating pregnancy. 12. Mental disorder that affects informed consent or study protocol
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Naohiro Middle name Last name Sata
Organization	Jichi Medical University Hospital
Division name	Department of Surgery
Zip code	329-0498
Address	3311-1, Yakushiji, Shimotsuke city, Tochigi, 329-0498, Japan
TEL	0285-58-7371
Email	sata@jichi.ac.jp

Public contact
Name of contact person	1st name Yoshinori Middle name Last name Hosoya
Organization	Jichi Medical University Hospital
Division name	Department of Surgery
Zip code	329-0498
Address	3311-1, Yakushiji, Shimotsuke city, Tochigi, 329-0498, Japan
TEL	0285-58-7371
Homepage URL
Email	hosoyo@jichi.ac.jp

Sponsor
Institute	Jichi Medical University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Support Center for Clinical Investigation, Jichi Medical University
Address	Yakushiji3311-1, Shimotsuke, Tochigi
Tel	0285-58-8933
Email	nintei-rinri@jichi.ac.jp

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	2016 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	12
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 03 Month 22 Day
Date of IRB	2016 Year 03 Month 22 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date	2020 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 10 Month 11 Day
Last modified on	2020 Year 11 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026344