Oral Supplementation of Glutamine on Gastric Cancer Patients After Gastrectomy

Gastric Cancer Clinical Trial

Official title:

Oral Supplementation of Glutamine on Gastric Cancer Patients After Gastrectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06027242
• Other study ID #: 202207099RINA
• Status: Recruiting
• Phase: N/A
• Start date: February 21, 2023
• Est. completion date: August 30, 2026

Study information

• Verified date: January 2023
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 30, 2026
• Est. primary completion date: August 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Gastrostomy
• Immunonutrition
• Stomach Neoplasms

Intervention

Dietary Supplement:
• oral glutamine
10 g glutamine +5 g Maltodextrin for 28 days after surgery with tolerable oral intake or enteral feeding
• Maltodextrin
Maltodextrin

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of area of psoas muscle	area od psoas muscle on the CT scan	84 days after gastrectomy
Secondary	Walking steps	the average daily walking steps recorded by the wearable devices	28,56, and 84 days after gastrectomy
Secondary	body weight	body weight	84 days after gastrectomy
Secondary	Change of serum albumin value		84 days after gastrectomy
Secondary	Change in white blood cells counts		84 days after gastrectomy
Secondary	Change in lymphocyte cells counts		84 days after gastrectomy
Secondary	Change of serum pre-albumin value		84 days after gastrectomy