NCT06278701Unknown不适用
Effects of Late-evening Snacks on Nutritional Status and Metabolic Pattern of Patients With Primary Hepatocellular Carcinoma After Hepatectomy
DU Yao1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2023年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Albumin rising
研究概览
简要总结
Late-evening snacks, in which a portion of food is moved to bedtime while the total amount of food eaten per day remains unchanged, can effectively improve the metabolic state of accelerated catabolism.
The goal of this clinical trial is to learn about the effects of late-evening snacks on health conditions of hepatocellular carcinoma patients who underwent hepatectomy, and to further explore the effects of late-evening snacks on patients' metabolic patterns. The main question it aims to answer are: • the effect of late-evening snacks on the nutritional status of hepatic resection patients with hepatocellular carcinoma;
- the effect of late-evening snacks on the recovery of liver function in liver cancer hepatectomy patients;
- the effect of late-evening snacks on the complication rate of hepatic resection patients with hepatocellular carcinoma;
- the effect of late-evening snacks on long-term quality of life of hepatic resection patients with hepatocellular carcinoma;
- the effect of late-evening snacks on the metabolic pattern of hepatic resection patients with hepatocellular carcinoma.
After learning about the 2 dietary modalities of the late-evening snacks and regular diet, patients will be placed in the different groups according to your preference. Patients who enter the test group will have additional meal 1h before bedtime every day, while patients in the control group will have normal diet. Patients will be asked to :
- eat 1h before bedtime;
- follow the doctor's instructions during their stay in the hospital;
- have follow-up examinations at 1 month, 3 months and 6 months after the operation, after which blood samples will be collected for metabolite testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years;
- •Meet the diagnostic criteria of China's "Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2022 Edition)", clinically diagnosed with primary liver cancer, hospitalized with radical hepatectomy as the main surgical treatment, no indication of metastasis of the tumor to extra-hepatic organs in preoperative tests and examinations, no absolute contraindications to surgery, complete resection of the liver tumor in the operation, and hepatocellular carcinoma confirmed by postoperative pathological diagnosis；
- •Child-Pugh grades A and B;
- •Preoperative Eastern Cooperative Oncology Group Physical Status Score (ECOG-PS) of 0 to 2;
- •The patient is conscious, has normal verbal communication, and is able to cooperate with the relevant examinations;
- •Fully informed about the study and voluntarily signed an informed consent form.
排除标准
- •Failure to meet selection criteria;
- •Nutritional assessment as cachexia;
- •Presence of contraindications to enteral nutrition (EN) or EN intolerance, such as acute gastrointestinal bleeding, intestinal obstruction.(≥ grade 3, National Cancer Institute-Common Terminology Criteria for Adverse Events [NCINCI-CTCAE v 5.0]);
- •Simultaneous combination of malignant tumors in other parts of the body;
- •Combined hepatic encephalopathy or definite infection on admission;
- •Known refractory metabolic diseases (e.g., poorly controlled diabetes mellitus or fasting glucose ≥10 mmol/L, hyperthyroidism, hypothyroidism, metabolic acidosis)；
- •Decreased renal function (defined as serum creatinine Cr level ≥176.8 μmol/L);
- •Intravenous or oral nutritional supplements, such as proteins, amino acids, etc., applied within one month prior to admission to the hospital;
- •Patients with severe stress or severe complications such as respiratory failure with severe cardiac, hepatic, renal and other insufficiencies；
- •Persons with mental and neurological disorders who are unable to cooperate with a physician;
- •Alzheimer's disease, cerebral atrophy, acute stage or sequelae of cerebrovascular disease, cognitive impairment;
- •Previously poor adherence to medication and nutritional counseling;
- •Critically ill and difficult to assess;
- •On the liver transplant waiting list or under consideration for liver transplantation, as such patients may discontinue follow-up before the end of the study;
- •Less than 12 months since last localized treatment (TACE or HAIC or ablative therapy);
- •Other circumstances that the researcher considers inappropriate for participation in the study.
结局指标
主要结局
Albumin rising
时间窗: Day 1 of admission/Post-operative day 6/1 month postoperative/3 months postoperative/6 months postoperative
Serum albumin levels in patients at each time point
次要结局
- Relapse-Free Survival(From the time the patient underwent hepatectomy until the date of first recording to the date of progression or death from any cause, whichever comes first, assessed up to 2 years)
- Prealbumin rising(Day 1 of admission/Post-operative day 6/1 month postoperative/3 months postoperative/6 months postoperative)
- Decrease in Total bilirubin(Day 1 of admission/Post-operative day 6/1 month postoperative/3 months postoperative/6 months postoperative)
- Lower total hospitalization costs(From admission to discharge，an average of 1 month)
- Improved quality of life(1 month postoperative/3 months postoperative/6 months postoperative)
- Decrease in Aspartate Aminotransferase(Day 1 of admission/Post-operative day 6/1 month postoperative/3 months postoperative/6 months postoperative)
- Decrease in Alanine Aminotransferase(Day 1 of admission/Post-operative day 6/1 month postoperative/3 months postoperative/6 months postoperative)
- Decrease in Cholinesterase(Day 1 of admission/Post-operative day 6/1 month postoperative/3 months postoperative/6 months postoperative)
研究者
DU Yao
Pharmacist-in-charge
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
研究点 (1)
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