Gastric Cancer
Conditions
Interventions
BCAA-containing 7.5% glucose, fat emulsion
4.3 % glucose
7.5 % glucose, fat emulsion
Sponsors
Kitasato University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The inclusion criteria were as follows: (i) age ranging between 20 and 84 years; (ii) histologically proven adenocarcinoma of the stomach; (iii) clinical stages I-IV a (based on the 15th edition of the Japanese Gastric Cancer Classification) with no distant metastasis with R0 resection; (iv) Eastern Cooperative Oncology Group performance status of 0-2; (v) planned surgery and (vi) written informed consent provided
Exclusion criteria
Exclusion criteria: The exclusion criteria were as follows: (i) other synchronous or metachronous cancers, as well as synchronous multiple cancers in the stomach; (ii) preoperative treatment with drugs for gastric cancer; (iii) neoadjuvant chemotherapy treatment; (iv) emergent surgery; (v) R1-R2 resection; (vi) cardiac disorders with a New York Heart Association functional classification of 2 or higher and/ or pulmonary disorders with a Hugh-Jones classification of 4 or higher and/ or sufficient organ function consisting of aspartate transaminase < 100 IU/L, alanine aminotransferase< 100 IU/L, total bilirubin < 2.0 mg/dL, and serum creatinine < 1.5 mg/dL; (vii) locomotion disorders; (viii) thrombotic disorders; (ix) allergic reaction to egg, soy beans, or thiamine; (x) insulin and/ or warfarin users; (xi) BCAA supplement users; (xii) mental disorders which may have affected the ability or willingness to provide informed consent or abide by the study protocol; and (xiii) After confirming that the patients met the inclusion/exclusion criteria, informed consent was obtained.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference of the % reduction in lean body mass between the BCAA-containing 7.5% glucose + fat emulsion group (Study group, Group A) and the 4.3% glucose group (Control group, Group B) at month after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference of the % reduction in lean body mass between the BCAA-containing 7.5% glucose + fat emulsion group (Study group, Group A) and the 7.5% glucose + fat emulsion group (Group C) at month after surgery | — |
Countries
Japan
Contacts
Public ContactMikiko Sakuraya
Kitasato University School of Medicine Department of Upper Gastrointestinal Surgery
Outcome results
None listed