Oral Supplementation of Glutamine on Gastric Cancer Patients After Gastrectomy

National Taiwan University

Status: Enrolling

Conditions: Gastric Cancer; Gastrostomy; Immunonutrition

Treatments: Dietary Supplement: oral glutamine; Dietary Supplement: Maltodextrin

Study type: Interventional

Funder types: Other

Identifiers

NCT06027242

202207099RINA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups, including a placebo group

Without oral glutamine supplementation

Placebo Comparator group

Description:

15 g Maltodextrin for 28 days after surgery with tolerable oral intake or enteral feeding

Treatment:

Dietary Supplement: Maltodextrin

With oral glutamine supplementation

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Maltodextrin

Dietary Supplement: oral glutamine