UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024364 |
|---|---|
| Receipt number | 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 | 2020/11/19 22:31:19 |
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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 | 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
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
hosoyo@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026344
