UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006499 |
|---|---|
| Receipt number | R000007710 |
| Scientific Title | The study of the safety and efficacy of elemental diet before adjuvant chemotherapy in patients with gastric cancer. |
| Date of disclosure of the study information | 2011/10/20 |
| Last modified on | 2015/05/01 13:53:35 |
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Basic information
Public title
The study of the safety and efficacy of elemental diet before adjuvant chemotherapy in patients with gastric cancer.
Acronym
Safety and efficacy of elemental diet before adjuvant chemotherapy in patients with gastric cancer.
Scientific Title
The study of the safety and efficacy of elemental diet before adjuvant chemotherapy in patients with gastric cancer.
Scientific Title:Acronym
Safety and efficacy of elemental diet before adjuvant chemotherapy in patients with gastric cancer.
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 evaluate whether nutritional therapy by elemental diet could increase the rate of initiating adjuvant chemotherapy and improve nutritional status in patients with gastric cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
The rate of initiating adjuvant chemotherapy within 6 weeks after surgery.
Key secondary outcomes
1)total rate of initiating adjuvant chemotherapy after surgery
2)incidence of diarrhea
3)nutritional status
4)safety and tolerability
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
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients assigned to trial group take elemental diet (ELENTAL) at least more than one pack a day from the 3rd post-operative day for 6 weeks.
All the patients including trial group take conventional post-operative meals from the 3rd post-operative day.
Interventions/Control_2
All the patients including trial group take conventional post-operative meals from the 3rd post-operative day.
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)age. 20<= and 80>=
2)planned to receive adjuvant chemotherapy by TS-1 within 6 weeks after surgery.
3)patients with fully understood the study procedures given informed consent after a sufficient explanation.
Key exclusion criteria
1)patient under some organ failure
2)with other severe diseases
3)patient relevant to contraindication to all use drugs
4)considered inadequate for inclusion in this trial by the physician
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akinori Takagane |
Organization
Hakodate Goryoukaku Hospital
Division name
Department of Surgery
Zip code
Address
38-3,Goryoukaku-chou,Hakodate,Hokkaido
TEL
0138-51-2295
takagane@gobyou.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akinori Takagane |
Organization
Hakodate Goryoukaku Hospital
Division name
Department of Surgery
Zip code
Address
38-3,Goryoukaku-chou,Hakodate,Hokkaido
TEL
0138-51-2295
Homepage URL
takagane@gobyou.com
Sponsor or person
Institute
Hakodate Goryoukaku Hospital
Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Pharmaceuticals Co.,Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
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
函館五稜郭病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 20 | 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
Completed
Date of protocol fixation
| 2011 | Year | 07 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 10 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 22 | Day |
Date analysis concluded
| 2015 | Year | 04 | Month | 06 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 07 | Day |
Last modified on
| 2015 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007710
