Unique ID issued by UMIN | UMIN000008056 |
---|---|
Receipt number | R000009490 |
Scientific Title | Randomised phase II trial of efficacy of early nutritional intervention with an elemental diet (ELENTAL) for gastic- cancer patients after surgical treatment. |
Date of disclosure of the study information | 2012/05/30 |
Last modified on | 2012/05/30 12:55:58 |
Randomised phase II trial of efficacy of early nutritional intervention with an elemental diet (ELENTAL) for gastic- cancer patients after surgical treatment.
Randomised phase II trial of efficacy of early nutritional intervention with an elemental diet (ELENTAL) for gastic- cancer patients after surgical treatment.
Randomised phase II trial of efficacy of early nutritional intervention with an elemental diet (ELENTAL) for gastic- cancer patients after surgical treatment.
Randomised phase II trial of efficacy of early nutritional intervention with an elemental diet (ELENTAL) for gastic- cancer patients after surgical treatment.
Japan |
Gastric Cancer
Gastrointestinal surgery |
Malignancy
NO
This study is performed to examine the effect of early nutritional intervention with an elemental diet on the inhibition of body weight loss observed during the early postoperative period in patients who had undergone curative resection for gastric cancer.
Efficacy
Exploratory
Pragmatic
Phase II
Rate of body weight loss from before surgery to 6-8 weeks after surgery
Compliance with ELENTAL nutritional indices during the study period (serum albumin, serum total protein, serum total cholesterol and peripheral blood lymphocyte count), and the frequencies and grades of adverse events
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
YES
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
ELENTAL group: After surgery, oral administration of ELENTAL at 300 kcal/day is started when porridge or regular diet becomes ingestible, and continues for 6 to 8 weeks while the patient remains hospitalized (three times daily, between meals).
Control group:Only eat regular diet, not administration of ELENTAL
20 | years-old | <= |
Not applicable |
Male and Female
Patients satisfying all of the following criteria and not falling under any of the exclusion criteria described below were eligible for the study. The "Japanese Classification of Gastric Carcinoma (The 14th Edition)" is utilized for this study.
ases 20
1) years of age or older
2)Cases histologically diagnosed as gastric cancer
3)Cases with clinical stage I, II or III, judged as curative resection (R0) at the end of surgery
4)Cases with a performance status (ECOG) of 0 to 2
5)Cases without prior history of chemotherapy and radiotherapy, including therapies for other cancers
6)Cases judged as suitable for satisfactory oral intake of an elemental diet
7)Cases providing written consent for receiving this diet therapy
8)Cases without any postoperative complication that may potentially interfere with the conduct of this study
Cases meeting any of the following criteria are not included in this study.
1)Cases with synchronous or metachronous double cancers/multiple cancers
However, the following cases were eligible for the study.
- Cases with synchronous or metachronous double cancers of cervical carcinoma in situ or focal cancer in colonic adenoma
- Cases with synchronous multiple cancers in which the stage of the primary lesion is not affected by coexisting lesions
- Cases with metachronous multiple cancer (prior history of gastric cancer) with prior lesions satisfying the conditions according to "Guidelines of Japanese gastric cancer treatment (October 2010, The 3rd Edition), and endoscopic mucosal resection was performed
2)Case contraindicated for ELENTAL®
3)Cases with active infections
4)Cases with uncontrolled hypertension
5)Cases with uncontrolled diabetes
6)Cases with clinically problematic cardiac disease
7)Cases with severe pulmonary disease (including interstitial pneumonia, lung fibrosis and severe pulmonary emphysema)
8)Cases with prior history of clinically problematic mental disorder or central nervous system disorder
9)Cases who are pregnant or lactating, or have childbearing potential (intention)
10)Cases participating in other clinical studies with overlapping endpoints
11)Cases judged as being unsuitable for this study by the principal investigator
108
1st name | |
Middle name | |
Last name | Hiroshi Imamura |
Sakai City Hospital
Surgery
1-1-1, Minamiyasui-cho, Sakai
1st name | |
Middle name | |
Last name |
Sakai City Hospital
Surgery
1-1-1, Minamiyasui-cho, Sakai
KSES
KSES
Self funding
NO
2012 | Year | 05 | Month | 30 | Day |
Unpublished
Open public recruiting
2011 | Year | 08 | Month | 10 | Day |
2011 | Year | 11 | Month | 01 | Day |
2012 | Year | 05 | Month | 30 | Day |
2012 | Year | 05 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009490
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |