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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045645
Receipt No. 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 2021/10/02

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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
Email 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
Email hichikawa-nii@med.niigata-u.ac.jp

Sponsor
Institute Niigata University
Institute
Department

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
Email 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
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
2021 Year 09 Month 27 Day
Date of IRB
2021 Year 09 Month 27 Day
Anticipated trial start date
2021 Year 11 Month 01 Day
Last follow-up date
2023 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2024 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2021 Year 10 Month 02 Day
Last modified on
2021 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052108

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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