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 | 2026/04/13 13:45:47 |
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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
https://www.sciencedirect.com/science/article/pii/S2405457725017668?via%3Dihub
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S2405457725017668?via%3Dihub
Number of participants that the trial has enrolled
50
Results
Data were available for 45 patients. %BWL was 7.5% at 3 months postoperatively. The group with ONS intake <200 kcal/day tended to show a lower %BWL; however, this was not significant. No correlation was observed between ONS and regular dietary calorie intake. The required calorie intake was 1588 kcal/day. The sufficient group, whose total calorie intake met the requirements, had significantly reduced body weight loss, compared with the insufficient group.
Results date posted
| 2026 | Year | 04 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Fifty patients with gastric cancer who underwent distal or total gastrectomy at Kobe University Hospital were included in this study.
Participant flow
The eligibility criteria were as follows: age 18 years or over; being scheduled to undergo curative distal or total gastrectomy with lymph node dissection for gastric cancer diagnosed as clinical stage 1-3; an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-2; being able to sustain oral intake of regular diet for 3 months postoperatively; and being able to record and provide photos of their own regular diet. The exclusion criteria were as follows: remnant gastric cancer, contraindications for INOLAS, receiving steroids or immunosuppressive drugs for comorbidities, complicated viral infections requiring treatment, and difficulty in obtaining informed consent to participate in this study.
Adverse events
Mild diarrhea associated with oral nutritional supplement intake was observed in 11% of patients. None of the cases affected continuation of the study.
Outcome measures
The primary endpoint of this study was the percent body weight loss (%BWL) at 3 months after surgery. Body weight was measured at our hospital before surgery and during follow-up visits at 1, 1.5, 2, 2.5, and 3 months after surgery. Among these, %BWL at 3 months postoperatively was calculated based on the preoperative weight and the weight at 3 months after surgery.
Secondary endpoints included calorie intake from regular diet and ONS, protein intake from regular diet and ONS, hematological and biochemical examination findings (serum albumin, serum total cholesterol, and serum total lymphocyte count), skeletal muscle index (SMI) measured using bioelectrical impedance analysis, energy requirements, and screening tools of nutritional status as outlined below.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2026 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054111
