UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058255 |
|---|---|
| Receipt number | R000066085 |
| Scientific Title | A multicenter randomized controlled trial to evaluate the efficacy of Super Energy-dense oral nutritional supplementation (UpLead Mini) in postoperative gastric cancer patients. |
| Date of disclosure of the study information | 2025/06/23 |
| Last modified on | 2025/06/13 14:55:59 |
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Basic information
Public title
A multicenter randomized controlled trial to evaluate the efficacy of Super Energy-dense oral nutritional supplementation (UpLead Mini) in postoperative gastric cancer patients.
Acronym
RCT to evaluate the efficacy of SED ONS in postoperative gastric cancer patients.
Scientific Title
A multicenter randomized controlled trial to evaluate the efficacy of Super Energy-dense oral nutritional supplementation (UpLead Mini) in postoperative gastric cancer patients.
Scientific Title:Acronym
A multicenter randomized controlled trial to evaluate the efficacy of Super Energy-dense oral nutritional supplementation (UpLead Mini) in postoperative gastric cancer patients.
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to verify, through an open-label, prospective randomized trial, that administering a high-calorie enteral nutrition regimen (SED ONS) for 12 weeks to patients who underwent gastrectomy for gastric cancer, randomized into two groups, is superior to standard care alone in terms of suppressing postoperative weight loss.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage change in weight at Day 84 (12 weeks after discharge) based on preoperative weight
Key secondary outcomes
1.Body weight change rate at baseline (pre-surgery weight), before the start of the intervention, Day 28, Day 56, Day 182, and Day 365
2.Body weight change rate at Day 28, Day 56, Day 84, Day 182, and Day 365 relative to the weight before the start of the intervention
3.Change rate in daily food intake (5-point self-assessment compared to pre-surgery, recorded in a diary)
4.Nutritional supplement intake (nutritional supplement diary)
5.Daily food intake (energy intake) relative to preoperative levels at the start of the study, Day 28, Day 56, and Day 84 (temperature plate information at the start of the study, and nutritional guidance for other periods)
6.Quality of life assessment: PGSAS-37 (Postgastrectomy Syndrome Assessment Scale)8 before allocation, Day 84
7.Chemotherapy completion rate and adverse event assessment (only in cases where chemotherapy was administered) Day 84, Day 182, Day 365
8.Nutritional blood test values (total lymphocyte count, total protein, albumin, total cholesterol, prealbumin, cholinesterase) Pre-surgery, pre-randomization, Day 28, Day 56, Day 84, Day 182, Day 365
9.Body composition (impedance method) Changes in muscle mass, body fat mass, body fat percentage, skeletal muscle mass, and SMI from baseline (pre-surgery) to pre-randomization, Day 28, Day 56, Day 84, Day 182, and Day 365. However, measurements are not performed in patients with pacemakers.
10.Changes in grip strength and change rate Pre-surgery, Day 84
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Participants in Group A (SED ONS implementation) will begin taking SED ONS one day prior to the scheduled hospital admission date. SED ONS provides 400 kcal per 100 ml per day. Nutritional counseling will be provided to participants in Group A prior to discharge, and instructions on appropriate post-discharge meals will be explained.Prior to discharge, weight, body composition measurements, and QOL assessments will be conducted. Participants will self-assess their daily food intake by recording the ratio of their actual intake to the standard preoperative meal intake in a self-report diary. Additionally, instructions on how to take SED ONS and record intake in the diary will be provided.
After discharge, weight and body composition measurements will be conducted at outpatient visits on Days 28, 56, and 84. On Day 84, grip strength measurement and QOL assessment will also be performed. Blood tests will be recorded as part of routine clinical care. Weight and body composition measurements will be conducted again on Days 182 and 365.
Interventions/Control_2
Participants in Group B (control group) will receive nutritional counseling prior to discharge and be instructed on appropriate post-discharge diets. Weight, body composition measurements, and QOL assessments will be conducted prior to discharge. Participants will self-assess their daily food intake by recording the ratio of their intake to the preoperative standard dietary intake in a self-report diary.
After discharge, weight and body composition measurements will be conducted at outpatient visits on days 28, 56, and 84. On day 84, grip strength measurements and QOL assessments will also be conducted. Blood tests will be recorded as part of routine clinical care.Additionally, weight and body composition measurements will be conducted at 182 days and 365 days.
In Group B, if weight is less than 92% of preoperative weight at 84 days, SED ONS will be initiated from that point. The daily intake amount and timing will be the same as in Group A.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients who underwent curative surgery for gastric cancer
2. Preoperative ECOG Performance Status: 0-2
3. Patients capable of oral intake
4. Patients capable of managing test meals and recording intake
5. Patients who have provided informed consent to participate in this study
Key exclusion criteria
1.Patients with milk or gelatin allergies
2.Patients who required nutritional supplementation with ONS prior to surgery
3.Patients who underwent non-curative resection
4.Patients who required fasting for 28 days or longer due to postoperative complications
5.Patients with active concurrent cancer
6.Patients with diabetes who require insulin injections even after discharge
7.Patients undergoing hemodialysis
8.Other patients deemed inappropriate for study participation by the attending physician
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Fumihiko |
| Middle name | |
| Last name | Hatao |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
Department of Surgery
Zip code
183-8524
Address
2-8-29 Musashidai, Fuchu-shi, Tokyo
TEL
0423235111
fchobi@gmail.com
Public contact
Name of contact person
| 1st name | Fumihiko |
| Middle name | |
| Last name | Hatao |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
Department of Surgery
Zip code
183-8524
Address
Department of Surgery
TEL
0423235111
Homepage URL
fchobi@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan Tama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Tama Medical Center
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Children's Medical Center
Address
2-8-29, Musashidai, Fuchu-shi, Tokyo
Tel
042-300-5111
sn_erb@tmhp.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2024b-149
Org. issuing International ID_1
Tokyo Metropolitan Children's Medical Center
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 23 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 23 | Day |
Last modified on
| 2025 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066085
