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Oral Supplementation of Glutamine on Gastric Cancer Patients After Gastrectomy

Primary Purpose

Gastric Cancer, Immunonutrition, Gastrostomy

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
oral glutamine
Maltodextrin
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric cancer, Gastrectomy, sarcopenia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Without oral glutamine supplementation

With oral glutamine supplementation

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change of area of psoas muscle
area od psoas muscle on the CT scan

Secondary Outcome Measures

Walking steps
the average daily walking steps recorded by the wearable devices
body weight
body weight
Change of serum albumin value
Change in white blood cells counts
Change in lymphocyte cells counts
Change of serum pre-albumin value

Full Information

First Posted
August 17, 2023
Last Updated
September 6, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06027242
Brief Title
Oral Supplementation of Glutamine on Gastric Cancer Patients After Gastrectomy
Official Title
Oral Supplementation of Glutamine on Gastric Cancer Patients After Gastrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 21, 2023 (Actual)
Primary Completion Date
August 30, 2026 (Anticipated)
Study Completion Date
August 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Immunonutrition, Gastrostomy
Keywords
Gastric cancer, Gastrectomy, sarcopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Without oral glutamine supplementation
Arm Type
Placebo Comparator
Arm Description
15 g Maltodextrin for 28 days after surgery with tolerable oral intake or enteral feeding
Arm Title
With oral glutamine supplementation
Arm Type
Active Comparator
Arm Description
10 g glutamine +5 g Maltodextrin for 28 days after surgery with tolerable oral intake or enteral feeding
Intervention Type
Dietary Supplement
Intervention Name(s)
oral glutamine
Intervention Description
10 g glutamine +5 g Maltodextrin for 28 days after surgery with tolerable oral intake or enteral feeding
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Intervention Description
Maltodextrin
Primary Outcome Measure Information:
Title
Change of area of psoas muscle
Description
area od psoas muscle on the CT scan
Time Frame
84 days after gastrectomy
Secondary Outcome Measure Information:
Title
Walking steps
Description
the average daily walking steps recorded by the wearable devices
Time Frame
28,56, and 84 days after gastrectomy
Title
body weight
Description
body weight
Time Frame
84 days after gastrectomy
Title
Change of serum albumin value
Time Frame
84 days after gastrectomy
Title
Change in white blood cells counts
Time Frame
84 days after gastrectomy
Title
Change in lymphocyte cells counts
Time Frame
84 days after gastrectomy
Title
Change of serum pre-albumin value
Time Frame
84 days after gastrectomy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Ming Wu, MD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin-Ming Wu, MD
Phone
886-223123456
Email
wujm0531@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Oral Supplementation of Glutamine on Gastric Cancer Patients After Gastrectomy

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