A Study on the Safety of Leucine-Restricted Diet in Patients With Gastric Cancer
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- The adverse event of leucine-restricted diet in patients with gastric cancer
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Experimental Group
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.
干预措施: Leucine-restricted diet. (Dietary Supplement)
结局指标
主要结局
The adverse event of leucine-restricted diet in patients with gastric cancer
时间窗: 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
Amino acid concentration
时间窗: 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 safety of leucine-restricted diet in patients with gastric cancer
时间窗: 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
次要结局
- 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.)