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Oral Supplementation of Glutamine on Gastric Cancer Patients After Gastrectomy

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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

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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