Perioperative Glutamine Supplementation and Cachexia

August 20, 2021 updated by: National Taiwan University Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
550

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 month after surgery
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.
3 month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 14, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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