Gastric Cancer
Conditions
Interventions
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 hospi
Sponsors
KSES
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of body weight loss from before surgery to 6-8 weeks after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Outcome results
None listed