Oral Supplementation of Glutamine on Gastric Cancer Patients After Gastrectomy

Not Applicable

Recruiting

• Conditions: Immunonutrition; Gastrostomy; Gastric Cancer
• Interventions: Dietary Supplement: Maltodextrin; Dietary Supplement: oral glutamine

• Registration Number: NCT06027242
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Study Start: 2023-02-21
• Study First Submitted: 2023-08-17
• Study First Submitted QC: 2023-09-05
• Study First Posted: 2023-09-07
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-18
• Primary Completion: 2026-08-30
• Study Completion: 2026-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Without oral glutamine supplementation	Maltodextrin	15 g Maltodextrin for 28 days after surgery with tolerable oral intake or enteral feeding
With oral glutamine supplementation	oral glutamine	10 g glutamine +5 g Maltodextrin for 28 days after surgery with tolerable oral intake or enteral feeding
With oral glutamine supplementation	Maltodextrin	10 g glutamine +5 g Maltodextrin for 28 days after surgery with tolerable oral intake or enteral feeding

Primary Outcome Measures

Name	Time	Method
Change of area of psoas muscle	84 days after gastrectomy	area od psoas muscle on the CT scan

Secondary Outcome Measures

Name	Time	Method
body weight	84 days after gastrectomy	body weight
Walking steps	28,56, and 84 days after gastrectomy	the average daily walking steps recorded by the wearable devices
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

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan