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Oral Supplementation of Glutamine on Gastric Cancer Patients After Gastrectomy

NCT ID: NCT06027242

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-21

Study Completion Date

2026-08-30

Brief Summary

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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

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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.

Conditions

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Gastric Cancer Immunonutrition Gastrostomy

Keywords

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Gastric cancer Gastrectomy sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Without oral glutamine supplementation

15 g Maltodextrin for 28 days after surgery with tolerable oral intake or enteral feeding

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin

With oral glutamine supplementation

10 g glutamine +5 g Maltodextrin for 28 days after surgery with tolerable oral intake or enteral feeding

Group Type ACTIVE_COMPARATOR

oral glutamine

Intervention Type DIETARY_SUPPLEMENT

10 g glutamine +5 g Maltodextrin for 28 days after surgery with tolerable oral intake or enteral feeding

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin

Interventions

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oral glutamine

10 g glutamine +5 g Maltodextrin for 28 days after surgery with tolerable oral intake or enteral feeding

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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National Taiwan University Clinical Trial Center

Jin-Ming Wu, Clinical Associate Professor & PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jin-Ming Wu, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Jin-Ming Wu, MD

Role: CONTACT

Phone: 886+223123456

Email: [email protected]

Ming-Tsan Lin, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Jin-Ming Wu, MD

Role: primary

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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202207099RINA

Identifier Type: -

Identifier Source: org_study_id