UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042307 |
|---|---|
| Receipt number | R000047921 |
| Scientific Title | Phase III trial to evaluate the efficacy of nutrition and exercise intervention on lean body mass loss after gastrectomy for gastric cancer (NEx-RCT)-Open-label randomized trial |
| Date of disclosure of the study information | 2020/10/31 |
| Last modified on | 2022/11/02 20:33:46 |
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Basic information
Public title
Phase III trial to evaluate the efficacy of nutrition and exercise intervention on lean body mass loss after gastrectomy for gastric cancer (NEx-RCT)-Open-label randomized trial
Acronym
A phase III trial on nutrition and exercise intervention after gastrectomy (NEx-RCT)
Scientific Title
Phase III trial to evaluate the efficacy of nutrition and exercise intervention on lean body mass loss after gastrectomy for gastric cancer (NEx-RCT)-Open-label randomized trial
Scientific Title:Acronym
A phase III trial on nutrition and exercise intervention after gastrectomy (NEx-RCT)
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 early nutrition and exercise intervention on lean body mass loss after gastrectomy in a phase III study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
%lean body mass loss at 3 months after gastrectomy.
Key secondary outcomes
The change of body weight, body composition, walking speed, hand grip strength, 5-time chair stand test, nutritional index up to 1 year after surgery. Incidence of complication.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food | Maneuver |
Interventions/Control_1
Oral supplementation of 1 pack of leucine rich amino acid supplement per day for 90 days from the 2nd day after surgery.
Rehabilitation is carried out every day in line with behavior objective from the next day after surgery.
Interventions/Control_2
Routine care
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
i) Histologically proven adenocarcinoma of the stomach.
ii) Clinical stage I-IVA gastric cancer that is expected to be R0 resection.
iii) ECOG performance status 0-1.
iv) Planned surgery and no restriction on the procedure of gastrectomy.
v) Written informed consent.
Key exclusion criteria
i) Synchronous cancer
ii) Severe heart and pulmonary disorder
iii) Preoperative tube feeding is needed due to poor oral intake.
iv) Allergic reaction to apple.
v) Oral nutritional supplements are taken.
vi) When the examining physician judges that she/he is not adequate for the study.
Target sample size
242
Research contact person
Name of lead principal investigator
| 1st name | Souya |
| Middle name | |
| Last name | Nunobe |
Organization
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Division name
Department of Gastroenterological Surgery
Zip code
135-8550
Address
3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan.
TEL
03-3520-0111
souya.nunobe@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Ida |
Organization
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Division name
Department of Gastroenterological Surgery
Zip code
135-8550
Address
3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan.
TEL
03-3520-0111
Homepage URL
satoshi.ida@jfcr.or.jp
Sponsor or person
Institute
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Institute
Department
Personal name
Funding Source
Organization
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Cancer Institute Hospital
Address
3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan.
Tel
03-3570-0210
med.shinsa@jfcr.or.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
公益財団法人がん研究会有明病院 （東京）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2023 | 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
| 2020 | Year | 10 | Month | 31 | Day |
Last modified on
| 2022 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047921
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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