Oral Supplementation of Glutamine on Gastric Cancer Patients After Gastrectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Oral Supplementation of Glutamine on Gastric Cancer Patients After Gastrectomy

Conditions
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Gastric Cancer, Immunonutrition, Gastrostomy

Intervention / Treatment
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* Dietary Supplement: oral glutamine
* Dietary Supplement: Maltodextrin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Without oral glutamine supplementation<br>15 g Maltodextrin for 28 days after surgery with tolerable oral intake or enteral feeding | Dietary Supplement: Maltodextrin<br>* Maltodextrin<br>|
| Active Comparator: With oral glutamine supplementation<br>10 g glutamine +5 g Maltodextrin for 28 days after surgery with tolerable oral intake or enteral feeding | Dietary Supplement: oral glutamine<br>* 10 g glutamine +5 g Maltodextrin for 28 days after surgery with tolerable oral intake or enteral feeding<br>Dietary Supplement: Maltodextrin<br>* Maltodextrin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of area of psoas muscle | area od psoas muscle on the CT scan | 84 days after gastrectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking steps | the average daily walking steps recorded by the wearable devices | 28,56, and 84 days after gastrectomy | 
| body weight | body weight | 84 days after gastrectomy | 
| Change of serum albumin value |  | 84 days after gastrectomy | 
| Change in white blood cells counts |  | 84 days after gastrectomy | 
| Change in lymphocyte cells counts |  | 84 days after gastrectomy | 
| Change of serum pre-albumin value |  | 84 days after gastrectomy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric cancer, Gastrectomy, sarcopenia