UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003014 |
|---|---|
| Receipt number | R000003585 |
| Scientific Title | The exploratory study for the efficacy of rikkunshito on anorexia in the patients with TS-1 treatment |
| Date of disclosure of the study information | 2010/02/01 |
| Last modified on | 2018/02/06 13:12:42 |
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Basic information
Public title
The exploratory study for the efficacy of rikkunshito on anorexia in the patients with TS-1 treatment
Acronym
The exploratory study for the efficacy of rikkunshito on anorexia in the patients with TS-1 treatment
Scientific Title
The exploratory study for the efficacy of rikkunshito on anorexia in the patients with TS-1 treatment
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Koji Yakabi |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
1981 Kamoda, Kawagoe-shi, SAITAMA
TEL
0049-228-3741
kjyakabi@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Yakabi |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
1981 Kamoda, Kawagoe-shi, SAITAMA
TEL
049-228-3741
Homepage URL
kjyakabi@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Terminated
Date of protocol fixation
| 2009 | Year | 12 | Month | 14 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003585
