Perioperative Glutamine Supplementation and Cachexia

NCT05023499 | Completed

• 1 other identifier: 201909033RIND
• Study Type: observational
• Target: 550
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Glutamine; Metabolic Disorder; Cachexia

Keywords

Gastric cancer; cachexia; psoas muscle; glutamine

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

Without glutamine supplementation

no glutamine use

Drug: SYMPT-X Glutamine, Oral Powder for Reconstitution

Interventions

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.

Also known as: SYMPT-X

With glutamine supplementation; Without glutamine supplementation

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• gastric cancer patients undergoing gastrectomy

You may not qualify if:

• hepatic or renal failures

Sponsors & Collaborators

• National Taiwan University Hospital: lead

MeSH Terms

Conditions

Metabolic Diseases; Cachexia; Stomach Neoplasms

Interventions

Powders

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2021
• First Posted: August 26, 2021
• Study Start: January 1, 2016
• Primary Completion: June 30, 2019
• Study Completion: August 14, 2021
• Last Updated: August 26, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share