Oral Supplementation of Glutamine on Gastric Cancer Patie... | NCT06027242

Studies
Oral Supplementation of Glutamine on Gastric Cancer Patients After Gastrectomy

NCT06027242

Sponsor

National Taiwan University Hospital

Status

Recruiting

Last Update Posted

Dec 23, 2025Actual

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Gastric Cancer
Immunonutrition
Gastrostomy

Interventions

oral glutamine
Maltodextrin

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 21, 2023Actual

Primary Completion Date

Aug 30, 2026Estimated

Completion Date

Aug 30, 2026Estimated

First Submitted Date

Aug 17, 2023

First Submission Date that Met QC Criteria

Sep 5, 2023

First Posted Date

Sep 7, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2025

Last Update Posted Date

Dec 23, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

National Taiwan University Clinical Trial Center, Jin-Ming Wu, Clinical Associate Professor & PhD, National Taiwan University HospitalPrincipal Investigator

Lead Sponsor

National Taiwan University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Without oral glutamine supplementation	Placebo Comparator	15 g Maltodextrin for 28 days after surgery with tolerable oral intake or enteral feeding	Dietary Supplement: Maltodextrin
With oral glutamine supplementation	Active Comparator	10 g glutamine +5 g Maltodextrin for 28 days after surgery with tolerable oral intake or enteral feeding	Dietary Supplement: oral glutamine Dietary Supplement: Maltodextrin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
oral glutamine	Dietary Supplement	10 g glutamine +5 g Maltodextrin for 28 days after surgery with tolerable oral intake or enteral feeding	With oral glutamine supplementation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Walking steps	the average daily walking steps recorded by the wearable devices	28,56, and 84 days after gastrectomy
body weight	body weight

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jin-Ming Wu, MD	Contact	886+223123456		wujm0531@gmail.com
Ming-Tsan Lin, MD	Contact			wujm0531@gmail.com

Overall Officials

Name	Affiliation	Role
Jin-Ming Wu, MD	National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei		100	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Nov 3, 2022	Sep 5, 2023	Prot_SAP_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms
D055948	Sarcopenia

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005973	Glutamine
C008315	maltodextrin

Ancestor Terms

ID	Term
D024361	Amino Acids, Basic
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins
D000599	Amino Acids, Diamino

Browse Leaves

Not provided

Browse Branches

Not provided