The Effect of Late-evening Snacks on Patients With Primary Hepatocellular Carcinoma After Hepatectomy

Not Applicable

Active, not recruiting

• Conditions: Liver Neoplasms
• Interventions: Other: late-evening snacks

• Registration Number: NCT06278701
• Lead Sponsor: DU Yao

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-01
• Status Verified: 2024-02
• Study First Submitted: 2024-02-05
• Study First Submitted QC: 2024-02-19
• Last Update Submitted: 2024-02-19
• Study First Posted: 2024-02-26
• Last Update Posted: 2024-02-26
• Primary Completion: 2025-01-31
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 106

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the test group	late-evening snacks	Patients who voluntarily accepted to have an additional meal 1h before bedtime (total calories 200-275kcal, protein 11.5g-18g, complex carbohydrates 25-55g).

Primary Outcome Measures

Name	Time	Method
Albumin rising	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

Secondary Outcome Measures

Name	Time	Method
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	Time from when the patient achieved complete remission after hepatectomy to the time of recurrence or cutoff for follow-up
Prealbumin rising	Day 1 of admission/Post-operative day 6/1 month postoperative/3 months postoperative/6 months postoperative	Serum levels of prealbumin in patients at each time point
Decrease in Total bilirubin	Day 1 of admission/Post-operative day 6/1 month postoperative/3 months postoperative/6 months postoperative	Serum levels of total bilirubin in patients at each time point
Lower total hospitalization costs	From admission to discharge，an average of 1 month	Total cost from patient hospitalization to discharge
Improved quality of life	1 month postoperative/3 months postoperative/6 months postoperative	Patients completed EORTC QLQ-C30 at various time points
Decrease in Aspartate Aminotransferase	Day 1 of admission/Post-operative day 6/1 month postoperative/3 months postoperative/6 months postoperative	Serum levels of aspartate aminotransferase in patients at each time point
Decrease in Alanine Aminotransferase	Day 1 of admission/Post-operative day 6/1 month postoperative/3 months postoperative/6 months postoperative	Serum levels of alanine aminotransferase in patients at each time point
Decrease in Cholinesterase	Day 1 of admission/Post-operative day 6/1 month postoperative/3 months postoperative/6 months postoperative	Serum levels of cholinesterase in patients at each time point

Trial Locations

Locations (1)

Drum Tower Hospital, Medical School of Nanjing University; 🇨🇳 Nanjing, Jiangsu, China