UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006413 |
|---|---|
| Receipt number | R000007190 |
| Scientific Title | Exploratory study of daikenchuto for nutritional management following colectomy of colon cancer. |
| Date of disclosure of the study information | 2011/10/01 |
| Last modified on | 2018/01/14 01:40:19 |
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Basic information
Public title
Exploratory study of daikenchuto for nutritional management following colectomy of colon cancer.
Acronym
Efficacy of daikenchuto for nutritional management of the patients after colectomy.
Scientific Title
Exploratory study of daikenchuto for nutritional management following colectomy of colon cancer.
Scientific Title:Acronym
Efficacy of daikenchuto for nutritional management of the patients after colectomy.
Region
| Japan |
Condition
Condition
Colon cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of daikenchuto for symptoms of intestinal dysmotility and malnutrition following colectomy of colon cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
GSRS(Japanese Version) score
Weight change ratio
Key secondary outcomes
Albumin
Total protein
PNI
Pre albumin
Retinal binding protein
- Total cholesterol
- CRP
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Test drug(Daikenchuto) is taken orally between preoperative day 2 and postoperative twelve week.
Interventions/Control_2
No treatment
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients who qualify for curative colonic resection (solely via laparoscopic surgery) for colon cancer.
Preoperative staging of disease: I, II, IIIa, IIIb
TNM category distribution: T=1-3, N=0-2, M=0
2)PS (ECOG Performance Status Scale): 0, 1
3)Patients who can orally administration of Daikenchuto
4)Age: over 20 yo.
5)Gender: no specification
6)Inpatient/Outpatient: Inpatient
7)Patients who can provide written informed consent
Key exclusion criteria
1)Patients with a history of laparotomy and endoscopic surgery
2)Patients with concomitant inflammatory bowel disease (ulcerative colitis, Crohn disease)
3)Patients requiring emergency surgery
4)Patients with double cancer
5)Patients with serious liver disorder
6)Patients with serious renal disorder
7)Patients with history of laparotomy and peritonitis (excludes surgery for appendicitis)
8)Patients who are taking other Kampo formulation(s)
9)Patients who are pregnant, possibly pregnant, nursing or considering pregnancy
10)Others, including patients who are unfit for the study as determined by the attending physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Susumu Eguchi |
Organization
Nagasaki University Hospital
Division name
Department of transplantation and digestive surgery
Zip code
Address
1-7-1, Sakamoto, Nagasaki
TEL
095-819-7316
sueguchi@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumihiko Fujita |
Organization
Nagasaki University Hospital
Division name
Department of transplantation and digestive surgery
Zip code
Address
1-7-1, Sakamoto, Nagasaki
TEL
095-819-7316
Homepage URL
ffujita-ngs@umin.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
長崎大学病院（長崎県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2011 | Year | 02 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 27 | Day |
Last modified on
| 2018 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007190
