Perioperative Glutamine Supplementation and Cachexia

Perioperative Glutamine Supplementation Restores Atrophy of Psoas Muscle in Gastric Adenocarcinoma Patients Undergoing Gastrectomy

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.

Study Overview

• Status: Completed
• Conditions: Cachexia; Glutamine; Metabolic Disorder
• Intervention / Treatment: Drug: SYMPT-X Glutamine, Oral Powder for Reconstitution

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 Type: Observational
• Enrollment (Actual): 550

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• gastric cancer patients undergoing gastrectomy

Exclusion Criteria:

• hepatic or renal failures

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
With glutamine supplementation; perioperative glutamine supplementation (PGS) was defined as the subjects with five-day parenteral plus one-month oral use.	Drug: SYMPT-X Glutamine, Oral Powder for Reconstitution; erioperative glutamine supplementation (PGS) was defined as the subjects with five-day parenteral plus one-month oral use.; Other Names: SYMPT-X
Without glutamine supplementation; no glutamine use	Drug: SYMPT-X Glutamine, Oral Powder for Reconstitution; erioperative glutamine supplementation (PGS) was defined as the subjects with five-day parenteral plus one-month oral use.; Other Names: SYMPT-X

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
area psoas major muscle (PMMA; cm2)	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.	3 month after surgery
volume of psoas major muscle (PMMV; cm3)	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.	3 month after surgery

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): August 14, 2021

Study Registration Dates

• First Submitted: August 15, 2021
• First Submitted That Met QC Criteria: August 20, 2021
• First Posted (Actual): August 26, 2021

Study Record Updates

• Last Update Posted (Actual): August 26, 2021
• Last Update Submitted That Met QC Criteria: August 20, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Gastric cancer; cachexia; glutamine; psoas muscle
• Additional Relevant MeSH Terms: Nutrition Disorders; Body Weight; Body Weight Changes; Emaciation; Weight Loss; Metabolic Diseases; Wasting Syndrome; Cachexia
• Other Study ID Numbers: 201909033RIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No