Unique ID issued by UMIN | UMIN000042307 |
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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 |
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
A phase III trial on nutrition and exercise intervention after gastrectomy (NEx-RCT)
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
A phase III trial on nutrition and exercise intervention after gastrectomy (NEx-RCT)
Japan |
Gastric cancer
Gastrointestinal surgery |
Malignancy
NO
To evaluate the efficacy of early nutrition and exercise intervention on lean body mass loss after gastrectomy in a phase III study.
Efficacy
Confirmatory
Pragmatic
Phase III
%lean body mass loss at 3 months after gastrectomy.
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.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
YES
YES
Institution is considered as a block.
NO
Central registration
2
Treatment
Food | Maneuver |
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.
Routine care
20 | years-old | <= |
80 | years-old | >= |
Male and Female
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.
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.
242
1st name | Souya |
Middle name | |
Last name | Nunobe |
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Department of Gastroenterological Surgery
135-8550
3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan.
03-3520-0111
souya.nunobe@jfcr.or.jp
1st name | Satoshi |
Middle name | |
Last name | Ida |
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Department of Gastroenterological Surgery
135-8550
3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan.
03-3520-0111
satoshi.ida@jfcr.or.jp
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Self funding
Cancer Institute Hospital
3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan.
03-3570-0210
med.shinsa@jfcr.or.jp
NO
公益財団法人がん研究会有明病院 (東京)
2020 | Year | 10 | Month | 31 | Day |
Unpublished
Open public recruiting
2020 | Year | 10 | Month | 30 | Day |
2020 | Year | 10 | Month | 30 | Day |
2020 | Year | 11 | Month | 16 | Day |
2023 | Year | 03 | Month | 31 | Day |
2020 | Year | 10 | Month | 31 | Day |
2022 | Year | 11 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047921
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