UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011919 |
|---|---|
| Receipt number | R000013918 |
| Scientific Title | Effects of intensive nutritional support after gastrectomy in patients with gastric cancer: a randomized controlled trial |
| Date of disclosure of the study information | 2013/10/01 |
| Last modified on | 2019/03/13 18:30:41 |
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Basic information
Public title
Effects of intensive nutritional support after gastrectomy in patients with gastric cancer: a randomized controlled trial
Acronym
Effects of intensive nutritional support after gastrectomy in patients with gastric cancer: a randomized controlled trial
Scientific Title
Effects of intensive nutritional support after gastrectomy in patients with gastric cancer: a randomized controlled trial
Scientific Title:Acronym
Effects of intensive nutritional support after gastrectomy in patients with gastric cancer: a randomized controlled trial
Region
| Japan |
Condition
Condition
Gastric cancer patients who underwent gastrectomy
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of intensive nutritional support for preventing postoperative body weight loss in patients with gastric cancer after undergoing gastrectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of change with weight in one year.
Key secondary outcomes
five year overall survival, compliance of adjuvant S-1, muscle mass, muscle strength, body composition, compliance of enteral nutrient, postoperative complication rate, postoperative quality of life, clinical blood examination
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Food |
Interventions/Control_1
An amount of 400ml/day of enteral nutritional supplement (Racol@ ) is administrated for patients with gastrectomy. This nutrition intervention is performed from postoperative day 2 today 90.
Interventions/Control_2
placebo group are received normal nutritional care.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) primary gastric cancer with preoperative diagnosis
2) planned surgical procedure: total, distal and proximal gastrectomy
3) R0 or R1 with CY positive in preoperative diagnosis
4) H0, P0 and M0 in preoperative diagnosis
5) Age>20 and <85 years
6) performance status: 0 to 2 (ECOG)
7) normal hepatic, renal and marrow function
8) possible to take orally
9) written informed consent
Key exclusion criteria
1) with severe complication or active dual malignancy
2) judged as inappropriate by physician-in-charge
3) short-bowel syndrome
4) stenosed gut tract
5) past history of drug allergy
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichiro Doki |
Organization
Osaka University School of Medicine
Division name
Gastroenterological Surgery
Zip code
Address
2-2 Yamadaoka Suita City Osaka
TEL
06-6879-3251
ydoki@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Gakuhara |
Organization
Osaka University School of Medicine
Division name
Gastroenterological Surgery
Zip code
Address
2-2 Yamadaoka Suita City Osaka
TEL
06-6879-3251
Homepage URL
agakuhara@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University School of Medicine Gastroenterological Surgery
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
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
| 2013 | Year | 10 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 09 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 15 | 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
| 2013 | Year | 09 | Month | 30 | Day |
Last modified on
| 2019 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013918
| Research Plan | |
|---|---|
| Registered date | File name |
| 2015/03/03 | QOL調査表 EORTC QLQ-C30_Ver3.0.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
