Gastric Cancer
Conditions
Keywords
Leucine-Restricted Diet, Gastric cancer
Brief summary
The primary objectives of this study is o evaluate the safety of a leucine-restricted diet in patients with gastric cancer and determine the impact of a leucine-restricted diet on serum amino acid concentrations in patients with gastric cancer.Besides,we can assess changes in the immune microenvironment of gastric cancer patients following administration of a leucine-restricted diet and observe alterations in body composition of gastric cancer patients after the application of a leucine-restricted diet.
Interventions
DIETARY_SUPPLEMENTLeucine-restricted diet.
During the preoperative waiting period after hospital admission, study participants received a leucine-restricted diet for three days prior to surgery. Surgical intervention was performed immediately following the 3-day dietary intervention. Postoperatively, patients gradually resumed a regular diet according to standard surgical protocols.
Sponsors
Qilu Hospital of Shandong University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Pathologically confirmed gastric carcinoma requiring preoperative endoscopic localization marking or delineation of the lesion extent. * Aged between 18 and 70 years, regardless of gender. * Ability to consume oral or nasogastric tube feeding of a liquid diet. * Provision of signed informed consent and voluntary participation in this study. * No evidence of distant metastasis on preoperative imaging studies (e.g., CT, PET-CT), and deemed suitable for surgical resection. * No concurrent diagnosis of other active malignancies.
Exclusion criteria
* Presence of cognitive impairment or psychological disorders that may compromise the understanding of the research content. * Diagnosis of Type I or Type II Diabetes Mellitus. * Severe diarrhea, intractable vomiting, severe malabsorption syndromes, paralytic or mechanical intestinal obstruction, or active gastrointestinal bleeding. * Known allergy to the primary components of the leucine-deficient nutritional formula. * Concurrent use of other nutritional supplements that may interfere with the trial's efficacy. * Postoperative pathological diagnosis confirming non-primary gastric cancer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amino acid concentration | Measurements were performed prior to the initiation of the amino acid-restricted diet and on the day of surgery before the operation | Following leucine-restricted diet intervention, peripheral venous blood was collected from gastric cancer patients to measure serum concentrations of various amino acids, including leucine |
| The adverse event of leucine-restricted diet in patients with gastric cancer | 6 months after surgery | This indicator was assessed using the Common Terminology Criteria for Adverse Event(CTCAE) grading system, which comprises five grades (1-5). Grade 1 represents no or mild symptoms, while Grade 5 indicates death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CD8+ T cell percentage | Measurements were performed prior to the initiation of the amino acid-restricted diet and on the day of surgery before the operation. | Following leucine-restricted diet intervention, peripheral venous blood was collected from gastric cancer patients to measure serum concentrations of CD8+ T cell percentage. |
Countries
China
Outcome results
None listed