Oral Supplementation of Glutamine on Gastric Cancer Patients After Gastrectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: oral glutamine, Maltodextrin.
- Who it may be relevant to
- Registry conditions: Gastric Cancer, Immunonutrition, Gastrostomy. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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
Primary outcome measures
- Change of area of psoas muscle [Time frame: 84 days after gastrectomy]
Secondary outcome measures (6)
- Walking steps [Time frame: 28,56, and 84 days after gastrectomy]
- body weight [Time frame: 84 days after gastrectomy]
- Change of serum albumin value [Time frame: 84 days after gastrectomy]
- Change in white blood cells counts [Time frame: 84 days after gastrectomy]
- Change in lymphocyte cells counts [Time frame: 84 days after gastrectomy]
- Change of serum pre-albumin value [Time frame: 84 days after gastrectomy]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- National Taiwan University Hospital — Taipei
Identifiers
NCT: NCT06027242 · 202207099RINA