Safety and Efficacy of Leucine-Restricted Diet in Gastric Cancer
Phase 1 – testing safety in a small group of people
Conditions:
Gastric Cancer
Sponsor: Qilu Hospital of Shandong University
trial.available_in:
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Overview
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.
Who can participate
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.