Oral Supplementation of Glutamine on Gastric Cancer Patients After Gastrectomy

September 6, 2023 updated by: National Taiwan University Clinical Trial Center, National Taiwan University Hospital
Glutamine has the potentials of immunomodulation and adjustment of protein metabolism. The primary objective of this study is to evaluate the efficacy of glutamine on sarcopenia in gastric adenocarcinoma patients undergoing gastrectomy. The secondary endpoints, including the physical activity, weight loss, and nutritional profiles, will be evaluated among these patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This will be a double-blind, randomized, and placebo-controlled study. At least 80 evaluable patients who are scheduled for gastrectomy for gastric adenocarcinoma cancer will be randomly assigned to the control or treatment group. Each group will have at least 40 patients. The CT scan will be evaluated before surgery and on postoperative day (POD) 90. Moreover, the patient will wear the smart watch to record daily walking steps. Laboratory data will be check before gastrectomy and on POD 90.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • adult gastric cancer receiving gastrectomy

Exclusion Criteria:

  • Hepatic insufficiency
  • Renal insufficiency
  • can not tolerate oral or enteral feeding 7 days after gastrectomy
  • can not receive computed tomograph
  • can not waer the wearable devices

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Without oral glutamine supplementation
15 g Maltodextrin for 28 days after surgery with tolerable oral intake or enteral feeding
Dietary supplement: Maltodextrin
Maltodextrin
Active Comparator: With oral glutamine supplementation
10 g glutamine +5 g Maltodextrin for 28 days after surgery with tolerable oral intake or enteral feeding
Dietary supplement: Maltodextrin
Maltodextrin
Dietary supplement: oral glutamine
10 g glutamine +5 g Maltodextrin for 28 days after surgery with tolerable oral intake or enteral feeding

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of area of psoas muscle
Time Frame: 84 days after gastrectomy
area od psoas muscle on the CT scan
84 days after gastrectomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Walking steps
Time Frame: 28,56, and 84 days after gastrectomy
the average daily walking steps recorded by the wearable devices
28,56, and 84 days after gastrectomy
body weight
Time Frame: 84 days after gastrectomy
body weight
84 days after gastrectomy
Change of serum albumin value
Time Frame: 84 days after gastrectomy
84 days after gastrectomy
Change in white blood cells counts
Time Frame: 84 days after gastrectomy
84 days after gastrectomy
Change in lymphocyte cells counts
Time Frame: 84 days after gastrectomy
84 days after gastrectomy
Change of serum pre-albumin value
Time Frame: 84 days after gastrectomy
84 days after gastrectomy

Collaborators and Investigators

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

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Jin-Ming Wu, MD, 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)

February 21, 2023

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

August 30, 2026

Study Registration Dates

First Submitted

August 17, 2023

First Submitted That Met QC Criteria

September 5, 2023

First Posted (Actual)

September 7, 2023

Study Record Updates

Last Update Posted (Actual)

September 8, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202207099RINA

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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