UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047451 |
|---|---|
| Receipt number | R000054111 |
| Scientific Title | The efficacy of oral nutritional therapy with ENORAS for the patients after gastrectomy and the evaluation for the nutritional index: exploratory prospective study |
| Date of disclosure of the study information | 2022/04/10 |
| Last modified on | 2024/04/11 15:33:27 |
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Basic information
Public title
The efficacy of oral nutritional therapy with ENORAS for the patients after gastrectomy and the evaluation for the nutritional index: exploratory prospective study
Acronym
Oral nutritional therapy with ENORAS and evaluation for nutritional index after gastrectomy
Scientific Title
The efficacy of oral nutritional therapy with ENORAS for the patients after gastrectomy and the evaluation for the nutritional index: exploratory prospective study
Scientific Title:Acronym
Oral nutritional therapy with ENORAS and evaluation for nutritional index after gastrectomy
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this study, the purpose is to clarify the correlation between total calorie intake at the 3 months after surgery including the adherence of ENORAS oral intake dose (continuous internal use completion rate) and each nutritional index item such as weight loss rate. In addition, we will explore the more useful index items to evaluate the efficacy of the oral nutritional supplement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Body weight loss rate at 3 months after gastrectomy
Key secondary outcomes
The adherence of ENORAS oral intake dose (continuous internal use completion rate), Total calorie intake at the 3 months after surgery (estimate from images or records of meal after gastrectomy), ECOG-PS, Nutritional index from blood test (TP, ALB, TLC), Bioelectrical impedance analysis, Visceral fat area and Skeletal muscle index from CT images
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
Oral nutritional supplements for patients after gastrectomy
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Gastric cancer patients who are diagnosed to be clinical Stage 1,2 and 3 according to the Japanese classification for gastric cancer and who are going to undergo distal gastrectomy or total gastrectomy
(2) ECOG-PS 0 to 2
(3) Patients who are able to oral intake before gastrectomy
(4) A patient whose written informed consent has been obtained
Key exclusion criteria
(1) Patients with allergies to oral nutritional supplements
(2) Patients who are judged unsuitable for the study by the principal investigator or sub-investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Kanaji |
Organization
Graduate School of Medicine, Kobe University
Division name
Division of Gastrointestinal Surgery, Department of Surgery
Zip code
650-0017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe City, Hyogo
TEL
078-382-5925
kanashin@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Harada |
Organization
Graduate School of Medicine, Kobe University
Division name
Division of Gastrointestinal Surgery, Department of Surgery
Zip code
650-0017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe City, Hyogo
TEL
078-382-5925
Homepage URL
htharada@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Kobe University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe Univ. Hosp. Clinical & Translational Research Center
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe City, Hyogo
Tel
078-382-6669
kainyu@med.kobe-u.ac.jp
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
神戸大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 10 | Day |
Last modified on
| 2024 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054111
