UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042579 |
|---|---|
| Receipt number | R000048596 |
| Scientific Title | Randomized comparative study to examine the effect of early exercise and parenteral nutrition therapy intervention on lean body mass loss after gastrectomy |
| Date of disclosure of the study information | 2020/11/30 |
| Last modified on | 2026/06/04 13:10:30 |
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Basic information
Public title
Randomized comparative study to examine the effect of early exercise and parenteral nutrition therapy intervention on lean body mass loss after gastrectomy
Acronym
Randomized comparative study on exercise and parenteral nutrition interventions after gastrectomy
Scientific Title
Randomized comparative study to examine the effect of early exercise and parenteral nutrition therapy intervention on lean body mass loss after gastrectomy
Scientific Title:Acronym
Randomized comparative study on exercise and parenteral nutrition interventions after gastrectomy
Region
| Japan |
Condition
Condition
Gastric Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of the early parental nutrition on lean body mass loss after gastrectomy in a randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of lean body mass loss on 7 days after gastrectomy.
Key secondary outcomes
1) Percentage of lean body mass loss on 1 month and 3 months after gastrectomy
2) Changes of body weight, body composition (lean body mass / skeletal muscle mass / muscle mass / fat mass), and skeletal muscle index up to 1 year after surgery
3) Changes in walking speed, grip strength, and 5 times chair standing test up to 1 year after surgery
4) Incidence of postoperative complications
5) Postoperative inflammatory condition
6) Changes in nutrition index up to 1 year after surgery
7) Energy intake up to 1 year after surgery
8) Postoperative exercise compliance
9) Postoperative chemotherapy compliance
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Amino acid-containing infusion is administered from 1st to 5th day after surgery.
Rehabilitation is carried out every day in line with behavior objective from the next day after surgery.
Interventions/Control_2
Maintenance infusion is administered from 1st to 5th day after surgery.
Rehabilitation is carried out every day in line with behavior objective from the next day after surgery.
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) Histologically proven adenocarcinoma of the stomach.
3) Clinical stage I-IVA gastric cancer that is expected to be curative (R0) resection.
4) PS: ECOG performance status score 0-2.
5) Planned surgery and no restriction on the procedure of gastrectomy.
Key exclusion criteria
1) Synchronous cancer
2) History of gastric cancer treatment (excluding endoscopic treatment)
3) Preoperative chemotherapy
4) Emergency surgery.
5) Surgical findings showing R1 or R2 resection.
6) Severe heart , lung , liver and kidney
disorder.
7) Activity restrictions due to complications such as quadriplegia.
8) Patients with thrombosis.
9) Hypersensitivity to eggs, soybeans, and thiamine chloride hydrochloride.
10) Taking insulin or warfarin.
11) Taking oral nutritional supplements and supplements (containing leucine).
12) Dementia, psychosis or psychiatric symptoms.
13) Others that the investigator considers inappropriate for participating in the exam
Target sample size
22
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, Minami-ku, Sagamihara, Kanagawa
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, Minami-ku, Sagamihara, Kanagawa
TEL
0427788111
Homepage URL
mikiko-mito@rg7.so-net.ne.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Kitasato 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
Kitasato University Hospital Treatment / Clinical Research Review Committee
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa
Tel
0427788111
m-kenkyu@kitasato-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
| 2020 | Year | 11 | Month | 30 | Day |
Related information
URL releasing protocol
https://doi.org/10.1007/s00423-023-03045-6
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1007/s00423-023-03045-6
Number of participants that the trial has enrolled
24
Results
At postoperative day 7, LBM loss in the BCAA group tended to be lower than in the control group (0.16% vs. 1.7%, respectively; P = 0.21), while at 1 month postsurgery, LBM loss in the BCAA group was significantly different from that in the control group (-0.3% vs. 4.5%, respectively; P = 0.04). At 3 months postgastrectomy, however, LBM loss was similar between the BCAA and control groups.
Results date posted
| 2026 | Year | 06 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study included gastric cancer patients undergoing gastrectomy. Patients were recruited between January 2021 and October 2021, and 24 cases were prospectively enrolled in this study (C20-274).
Participant flow
A total of 29 patients were enrolled. Of these, 16 were randomly assigned to the BCAA group and 13 to the control group. Three patients in the BCAA group who developed postoperative complications (CD grade III or higher) discontinued the intervention and were excluded from the safety analysis. Two patients in the control group who developed postoperative complications (CD grade III or higher) and had insufficient protein intake discontinued the intervention and were excluded from the safety analysis.
Adverse events
Complications (Clavien-Dindo classification grade II or higher) were observed in one patient in the BCAA group and two patients in the control group, with no significant difference in incidence between the groups. In the BCAA group, one patient developed an intra-abdominal abscess (CD IIIB) and underwent laparoscopic reoperation for drainage tube placement. In the control group, complications included food stasis (CD II, n = 1) and pancreatic fistula (CD II, n = 1). The former improved with peripheral parenteral nutrition (PPN) therapy, while the latter recovered with combined PPN and antibiotic therapy.
Outcome measures
The primary endpoint was the percentage reduction in LBM at POD7. The secondary endpoints were as follows: percentage reduction in LBM at 1 and 3 months postsurgery; percentage reduction in both body weight (BW) and body fat mass (BFM) at POD7, 1 month, and 3 months postsurgery; physical capacity, including handgrip strength (kilogram, kg), gait speed (meter/second, m/s) assessed by a 10 m walk, and a five-repetition sit-to-stand (SS-5) test (second, s); postoperative complications (Clavien-Dindo [CD] grade II or higher); postoperative inflammation status, including white blood cell count (/uL), C-reactive protein (mg/dL), albumin (g/dL), and pre-albumin (mg/dL); and exercise adherence.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 11 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 04 | 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
| 2020 | Year | 11 | Month | 27 | Day |
Last modified on
| 2026 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048596
