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Oral Supplementation of Glutamine on Gastric Cancer Patients After Gastrectomy

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ClinicalTrials.gov Identifier: NCT06027242
Recruitment Status : Recruiting
First Posted : September 7, 2023
Last Update Posted : September 8, 2023
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Clinical Trial Center, National Taiwan University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Immunonutrition Gastrostomy Dietary Supplement: oral glutamine Dietary Supplement: Maltodextrin Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oral Supplementation of Glutamine on Gastric Cancer Patients After Gastrectomy
Actual Study Start Date : February 21, 2023
Estimated Primary Completion Date : August 30, 2026
Estimated Study Completion Date : August 30, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
Drug Information available for: Glutamine

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

Dietary Supplement: Maltodextrin
Maltodextrin


Outcome Measures
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Primary Outcome Measures :
  1. Change of area of psoas muscle [ Time Frame: 84 days after gastrectomy ]
    area od psoas muscle on the CT scan


Secondary Outcome Measures :
  1. Walking steps [ Time Frame: 28,56, and 84 days after gastrectomy ]
    the average daily walking steps recorded by the wearable devices

  2. body weight [ Time Frame: 84 days after gastrectomy ]
    body weight

  3. Change of serum albumin value [ Time Frame: 84 days after gastrectomy ]
  4. Change in white blood cells counts [ Time Frame: 84 days after gastrectomy ]
  5. Change in lymphocyte cells counts [ Time Frame: 84 days after gastrectomy ]
  6. Change of serum pre-albumin value [ Time Frame: 84 days after gastrectomy ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06027242


Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Jin-Ming Wu, MD    886-223123456    wujm0531@gmail.com   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Jin-Ming Wu, MD National Taiwan University Hospital
  Study Documents (Full-Text)

Documents provided by National Taiwan University Clinical Trial Center, National Taiwan University Hospital:
Study Protocol and Statistical Analysis Plan  [PDF] November 3, 2022

More Information
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Responsible Party: National Taiwan University Clinical Trial Center, Jin-Ming Wu, Clinical Associate Professor & PhD, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT06027242    
Other Study ID Numbers: 202207099RINA
First Posted: September 7, 2023    Key Record Dates
Last Update Posted: September 8, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Taiwan University Clinical Trial Center, National Taiwan University Hospital:
Gastric cancer
Gastrectomy
sarcopenia
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases