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

Liver Neoplasms Clinical Trial

Official title:

Effects of Late-evening Snacks on Nutritional Status and Metabolic Pattern of Patients With Primary Hepatocellular Carcinoma After Hepatectomy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06278701
• Other study ID #: 2024-003-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: July 30, 2025

Study information

• Verified date: February 2024
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 106
• Est. completion date: July 30, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Neoplasms

Intervention

Other:
• late-evening snacks
have an additional meal 1h before bedtime (total calories 200-275kcal, protein 11.5g-18g, complex carbohydrates 25-55g).

Locations

Country	Name	City	State
China	Drum Tower Hospital, Medical School of Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
DU Yao

Country where clinical trial is conducted

China, 

References & Publications (22)

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* Note: There are 22 references in all — Click here to view all references

Outcome

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