UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045645 |
|---|---|
| Receipt number | R000052108 |
| Scientific Title | Oral nutritional supplements for the increase of oral caloric intake after gastrectomy: a single-arm prospective study |
| Date of disclosure of the study information | 2021/10/08 |
| Last modified on | 2025/04/05 13:17:05 |
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Basic information
Public title
Oral nutritional supplements for the increase of oral caloric intake after gastrectomy: a single-arm prospective study
Acronym
Oral nutritional supplements after gastrectomy
Scientific Title
Oral nutritional supplements for the increase of oral caloric intake after gastrectomy: a single-arm prospective study
Scientific Title:Acronym
Oral nutritional supplements after gastrectomy
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To test the hypothesis that oral administration of ENORAS to patients after gastrectomy will increase the proportion of patients who can take an average of 200 kcal or more per day as nutritional support.
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Proportion of patients who took an average of 200 kcal/day or more of oral nutrition
Key secondary outcomes
Weight loss rate, fat loss rate, and gluten loss rate 3 months after surgery
Weight loss rate, fat-free weight loss rate, and gluten reduction rate 1 year after surgery
Evaluation of various types of nutrition (TP, Alb, T-Chol, Rine pellet count, etc.)
Adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral intake of oral nutrition (ENORAS 187.5ml/pack) will be started within 3 days of the start of postoperative meals and continued until postoperative day 90. The dosage may be increased or decreased at the discretion of the physician in charge in consideration of the patient's subjective symptoms, etc., within the range of up to 3 packs/day (562.5 ml/day). The dosage may be increased or decreased at the discretion of the patient.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients with histologically confirmed gastric cancer
(2) Patients planned to undergo radical gastrectomy
(3) Patients without distant metastasis
(4) Patients aged between 20 and 80 years at the time of enrollment
(5) Patients with a PS (ECOG) of 0 or 1
(6) Patients with preserved major organ function according to clinical examination within 14 days prior to enrollment
(7) A patient whose written informed consent has been obtained
Key exclusion criteria
(1) Patients with carcinoma in the remnant stomach after gastrectomy
(2) Patients with active multiple cancers
(3) Patients with serious comorbidities (interstitial pneumonia or pulmonary fibrosis, difficult-to-control diabetes or hypertension, heart failure, renal failure, liver cirrhosis, liver failure, etc.)
(4) Patients with allergies to oral nutritional supplements
(5) Patients on warfarin medication
(6) Patients with lactose intolerance
(7) Patients with medical electrical devices such as pacemakers and implantable cardiac defibrillators
(8) Patients with motor disorders of the upper or lower limbs due to orthopedic or neurological diseases, etc.
(9) 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 | Hiroshi |
| Middle name | |
| Last name | Ichikawa |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Digestive and General Surgery
Zip code
951-8510
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata
TEL
025-227-2228
hichikawa-nii@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Ichikawa |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Digestive and General Surgery
Zip code
951-8510
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata
TEL
025-227-2228
Homepage URL
hichikawa-nii@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Niigata University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Niigata Cancer Center Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata
Tel
025-223-6161
ethics@adm.niigata-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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 08 | 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
50
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
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2024 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2025 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 02 | Day |
Last modified on
| 2025 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052108
