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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000011919
Receipt No. 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

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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
Email 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
Email agakuhara@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Osaka University School of Medicine Gastroenterological Surgery
Institute
Department

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
Email

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
URL(English) https://upload.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


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