Skip to main content
OpenTrials
Completed

NCT Number: NCT05023499

Perioperative Glutamine Supplementation and Cachexia

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • gastric cancer patients undergoing gastrectomy

Exclusion criteria

  • hepatic or renal failures

Treatment and study plan

SYMPT-X Glutamine, Oral Powder for Reconstitution

Drug

erioperative glutamine supplementation (PGS) was defined as the subjects with five-day parenteral plus one-month oral use.

Other names: SYMPT-X

Primary outcomes

  1. area psoas major muscle (PMMA; cm2)

    Time frame: 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.

  2. volume of psoas major muscle (PMMV; cm3)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2021
First posted
Aug 26, 2021
Registry last updated
Aug 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.