Clinical trial NCT06278701: The Effect of Late-evening Snacks on Patients With Primary Hepatocellular Carcinoma After Hepatectomy
Official title: Effects of Late-evening Snacks on Nutritional Status and Metabolic Pattern of Patients With Primary Hepatocellular Carcinoma After Hepatectomy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Liver Neoplasms
Keywords: Liver cancer
late evening snack
Metabolic pattern
Nutritional status
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study utilizes a grouping method based on patient preference. You will learn about the 2 dietary modalities, the late-evening snacks and the regular diet, and then you will be placed in the different groups according to your preference. Patients who volunteer for the 1h bedtime meal will be in the test group and those who volunteer for the regular diet will be in the control group. Dietary counseling and follow-up visits will be conducted in both groups, the difference being the presence or absence of the 1h bedtime meal pattern.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Albumin rising
timeFrame: Day 1 of admission/Post-operative day 6/1 month postoperative/3 months postoperative/6 months postoperative
Secondary outcomes:
measure: Prealbumin rising
timeFrame: Day 1 of admission/Post-operative day 6/1 month postoperative/3 months postoperative/6 months postoperative
measure: Decrease in Alanine Aminotransferase
timeFrame: Day 1 of admission/Post-operative day 6/1 month postoperative/3 months postoperative/6 months postoperative
measure: Decrease in Aspartate Aminotransferase
timeFrame: Day 1 of admission/Post-operative day 6/1 month postoperative/3 months postoperative/6 months postoperative
measure: Decrease in Cholinesterase
timeFrame: Day 1 of admission/Post-operative day 6/1 month postoperative/3 months postoperative/6 months postoperative
measure: Decrease in Total bilirubin
timeFrame: Day 1 of admission/Post-operative day 6/1 month postoperative/3 months postoperative/6 months postoperative
measure: Lower total hospitalization costs
timeFrame: From admission to discharge，an average of 1 month
measure: Relapse-Free Survival
timeFrame: 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
measure: Improved quality of life
timeFrame: 1 month postoperative/3 months postoperative/6 months postoperative
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Drum Tower Hospital, Medical School of Nanjing University
state: Jiangsu
Study officials:
affiliation: Drum Tower Hospital, Medical School of Nanjing University
name: Yao Du, Master
role: STUDY_DIRECTOR
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