Perioperative Glutamine Supplementation and Cachexia

Completed

• Conditions: Glutamine; Metabolic Disorder; Cachexia
• Interventions: Drug: SYMPT-X Glutamine, Oral Powder for Reconstitution

• Registration Number: NCT05023499
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

Background Sarcopenia is characterized by the degenerative loss of skeletal muscle and is associated with increased adverse surgical outcomes. Glutamine is considered as an immune-modulating formula, which may stimulate protein synthesis in the skeletal muscle but also inhibited protein-degradation. In this study, the investigators calculate the area and volume psoas major muscle (PMMA; PMMV) of the third lumbar vertebral body as the reference of skeletal muscle. The aim of this study is to investigate whether perioperative glutamine supplementation restores atrophy of psoas muscle.

Detailed Description

A total of 550 gastric adenocarcinoma (GA) patients undergoing gastrectomy were enrolled for the study. Computed tomography was used to assess the short axis of the psoas muscle, and the change was calculated between preoperative day and three months after gastrectomy. Perioperative glutamine supplementation (PGS) was defined as the subjects with five-day parenteral plus one-month oral use. A linear regression model was performed to predict this association by adjusting clinic-demographics and nutritional calories.

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2019-06-30
• Status Verified: 2021-08
• Study Completion: 2021-08-14
• Study First Submitted: 2021-08-15
• Study First Submitted QC: 2021-08-20
• Last Update Submitted: 2021-08-20
• Study First Posted: 2021-08-26
• Last Update Posted: 2021-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

• gastric cancer patients undergoing gastrectomy

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Exclusion Criteria

• hepatic or renal failures

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
With glutamine supplementation	SYMPT-X Glutamine, Oral Powder for Reconstitution	perioperative glutamine supplementation (PGS) was defined as the subjects with five-day parenteral plus one-month oral use.
Without glutamine supplementation	SYMPT-X Glutamine, Oral Powder for Reconstitution	no glutamine use

Primary Outcome Measures

Name	Time	Method
area psoas major muscle (PMMA; cm2)	3 month after surgery	We hypothesized that glutamine might play a role in improving sarcopenia. Both the PMMA and total volume of the psoas major muscle (PMMV) represent the severity of sarcopenia, because CT is routinely performed in surgical GA patients to check for cancer recurrence. The reason of including total volume into analysis is that it is considered a better index to define sarcopenia. \[21\] The primary and secondary endpoints were the perioperative change of PMMA and PMMV, respectively.
volume of psoas major muscle (PMMV; cm3)	3 month after surgery	We hypothesized that glutamine might play a role in improving sarcopenia. Both the PMMA and total volume of the psoas major muscle (PMMV) represent the severity of sarcopenia, because CT is routinely performed in surgical GA patients to check for cancer recurrence. The reason of including total volume into analysis is that it is considered a better index to define sarcopenia. \[21\] The primary and secondary endpoints were the perioperative change of PMMA and PMMV, respectively.