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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042579
Receipt No. 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 2020/11/27

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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
Email 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
Email mikiko-mito@rg7.so-net.ne.jp

Sponsor
Institute Kitasato University
Institute
Department

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
Email 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
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
2020 Year 11 Month 26 Day
Date of IRB
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
2020 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048596

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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