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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024364
Receipt No. R000026344
Scientific Title A pilot study to plan a protocol for the clinical trial evaluating the efficacy of Rikkunshito for patients after total gastrectomy
Date of disclosure of the study information 2016/11/01
Last modified on 2017/06/12

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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
Middle name
Last name Naohiro Sata
Organization Jichi Medical University Hospital
Division name Department of Surgery
Zip code
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
Middle name
Last name Yoshinori Hosoya
Organization Jichi Medical University Hospital
Division name Department of Surgery
Zip code
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
Address
Tel
Email

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 Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Open public recruiting
Date of protocol fixation
2016 Year 03 Month 22 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
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
2017 Year 06 Month 12 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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