Gastric Cancer, Gastrostomy, Immunonutrition
Conditions
Keywords
Gastric cancer, Gastrectomy, sarcopenia
Brief summary
Glutamine has the potentials of immunomodulation and adjustment of protein metabolism. The primary objective of this study is to evaluate the efficacy of glutamine on sarcopenia in gastric adenocarcinoma patients undergoing gastrectomy. The secondary endpoints, including the physical activity, weight loss, and nutritional profiles, will be evaluated among these patients.
Detailed description
This will be a double-blind, randomized, and placebo-controlled study. At least 80 evaluable patients who are scheduled for gastrectomy for gastric adenocarcinoma cancer will be randomly assigned to the control or treatment group. Each group will have at least 40 patients. The CT scan will be evaluated before surgery and on postoperative day (POD) 90. Moreover, the patient will wear the smart watch to record daily walking steps. Laboratory data will be check before gastrectomy and on POD 90.
Interventions
DIETARY_SUPPLEMENToral glutamine
10 g glutamine +5 g Maltodextrin for 28 days after surgery with tolerable oral intake or enteral feeding
DIETARY_SUPPLEMENTMaltodextrin
Maltodextrin
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult gastric cancer receiving gastrectomy
Exclusion criteria
* Hepatic insufficiency * Renal insufficiency * can not tolerate oral or enteral feeding 7 days after gastrectomy * can not receive computed tomograph * can not waer the wearable devices
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of area of psoas muscle | 84 days after gastrectomy | area od psoas muscle on the CT scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| body weight | 84 days after gastrectomy | body weight |
| Change of serum albumin value | 84 days after gastrectomy | — |
| Walking steps | 28,56, and 84 days after gastrectomy | the average daily walking steps recorded by the wearable devices |
| Change in lymphocyte cells counts | 84 days after gastrectomy | — |
| Change of serum pre-albumin value | 84 days after gastrectomy | — |
| Change in white blood cells counts | 84 days after gastrectomy | — |
Countries
Taiwan
Contacts
Primary ContactJin-Ming Wu, MD
Backup ContactMing-Tsan Lin, MD
Outcome results
None listed