UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054435 |
|---|---|
| Receipt number | R000062173 |
| Scientific Title | A phase III randomized controlled trial examining of early administration of BCAA-enriched PPN after gastrectomy |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2025/04/16 12:03:59 |
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Basic information
Public title
A phase III randomized controlled trial examining of early administration of BCAA-enriched PPN after gastrectomy
Acronym
A phase III randomized controlled trial examining of early administration of BCAA-enriched PPN after gastrectomy
Scientific Title
A phase III randomized controlled trial examining of early administration of BCAA-enriched PPN after gastrectomy
Scientific Title:Acronym
A phase III randomized controlled trial examining of early administration of BCAA-enriched PPN after gastrectomy
Region
| Japan |
Condition
Condition
Gastric Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We investigate the effect of our original PPN regimen including BCAA on lean body mass loss for patients undergoing gastrectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference of the % reduction in lean body mass between the BCAA-containing 7.5% glucose + fat emulsion group (Study group, Group A) and the 4.3% glucose group (Control group, Group B) at month after surgery
Key secondary outcomes
Difference of the % reduction in lean body mass between the BCAA-containing 7.5% glucose + fat emulsion group (Study group, Group A) and the 7.5% glucose + fat emulsion group (Group C) at month after surgery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
BCAA-containing 7.5% glucose, fat emulsion
Interventions/Control_2
4.3 % glucose
Interventions/Control_3
7.5 % glucose, fat emulsion
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria were as follows: (i) age ranging between 20 and 84 years; (ii) histologically proven adenocarcinoma of the stomach; (iii) clinical stages I-IV a (based on the 15th edition of the Japanese Gastric Cancer Classification) with no distant metastasis with R0 resection; (iv) Eastern Cooperative Oncology Group performance status of 0-2; (v) planned surgery and (vi) written informed consent provided
Key exclusion criteria
The exclusion criteria were as follows: (i) other synchronous or metachronous cancers, as well as synchronous multiple cancers in the stomach; (ii) preoperative
treatment with drugs for gastric cancer; (iii) neoadjuvant chemotherapy treatment; (iv) emergent surgery; (v) R1-R2 resection; (vi) cardiac disorders with a New York Heart Association functional classification of 2 or higher and/ or pulmonary disorders with a Hugh-Jones classification of 4 or higher and/ or sufficient organ function consisting of aspartate transaminase < 100 IU/L, alanine aminotransferase< 100 IU/L, total bilirubin < 2.0 mg/dL, and serum creatinine < 1.5 mg/dL; (vii) locomotion disorders; (viii) thrombotic disorders; (ix) allergic reaction to egg, soy beans, or thiamine; (x) insulin and/ or warfarin users; (xi) BCAA supplement users; (xii) mental disorders which may have affected the ability or willingness to provide informed consent or abide by the study protocol; and (xiii) After confirming that the patients met the inclusion/exclusion criteria, informed consent was obtained.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Hiki |
Organization
Kitasato University School of Medicine
Division name
Department of Upper Gastrointestinal Surgery
Zip code
252-0374
Address
1-15-1 Kitasato, Sagamihara, Kanagawa, Japan
TEL
0427788111
nhiki@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Mikiko |
| Middle name | |
| Last name | Sakuraya |
Organization
Kitasato University School of Medicine
Division name
Department of Upper Gastrointestinal Surgery
Zip code
252-0374
Address
1-15-1 Kitasato, Sagamihara, Kanagawa, Japan
TEL
0427788111
Homepage URL
mikiko-mito@rg7.so-net.ne.jp
Sponsor or person
Institute
Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
JAPANESE SOCIETY for SURGICAL METABOLISM and NUTRITION
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
Department of Upper Gastrointestinal Surgery Kitasato University of School of Medicine
Address
1-15-1 Kitasato, Sagamihara, Kanagawa, Japan
Tel
0427788111
mikiko-mito@rg7.so-net.ne.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
北里大学医学部上部消化管外科学（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2024 | Year | 05 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2031 | 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
| 2024 | Year | 05 | Month | 19 | Day |
Last modified on
| 2025 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062173
