AzTrials
AzTrials

Liver NeoplasmsNCT06278701

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

A study testing late-evening snacks in people with Liver Neoplasms, run by DU Yao at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Liver Neoplasms
What is being tested?
late-evening snacks
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
1 siteChina
Study dates
1 Nov 2023to 30 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)；
Show all 16Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Drum Tower Hospital, Medical School of Nanjing University

    Nanjing, Jiangsu, 210008

Other trials in China

About this study

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

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;

Read more
  • 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.
Conditions
Liver Neoplasms
Being tested
late-evening snacks
Keywords
Liver cancer, late evening snack, Metabolic pattern, Nutritional status
Medical subject headings
Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • late-evening snacksOther

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

Study groups in NCT06278701
Study groupRoleWhat they receive
the control groupNo interventionPatients who voluntarily accept a regular diet and do not eat again 1h before bedtime
the test groupExperimentalPatients who voluntarily accepted to have an additional meal 1h before bedtime (total calories 200-275kcal, protein 11.5g-18g, complex carbohydrates 25-55g).
Receives: Other: late-evening snacks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Albumin rising

    Serum albumin levels in patients at each time point

    Measured: Day 1 of admission/Post-operative day 6/1 month postoperative/3 months postoperative/6 months postoperative

Secondary outcomes (8)

  1. Prealbumin rising

    Serum levels of prealbumin in patients at each time point

    Measured: Day 1 of admission/Post-operative day 6/1 month postoperative/3 months postoperative/6 months postoperative

  2. Decrease in Alanine Aminotransferase

    Serum levels of alanine aminotransferase in patients at each time point

    Measured: Day 1 of admission/Post-operative day 6/1 month postoperative/3 months postoperative/6 months postoperative

  3. Decrease in Aspartate Aminotransferase

    Serum levels of aspartate aminotransferase in patients at each time point

    Measured: Day 1 of admission/Post-operative day 6/1 month postoperative/3 months postoperative/6 months postoperative

  4. Decrease in Cholinesterase

    Serum levels of cholinesterase in patients at each time point

    Measured: Day 1 of admission/Post-operative day 6/1 month postoperative/3 months postoperative/6 months postoperative

  5. Decrease in Total bilirubin

    Serum levels of total bilirubin in patients at each time point

    Measured: Day 1 of admission/Post-operative day 6/1 month postoperative/3 months postoperative/6 months postoperative

  6. Lower total hospitalization costs

    Total cost from patient hospitalization to discharge

    Measured: From admission to discharge，an average of 1 month

  7. Relapse-Free Survival

    Time from when the patient achieved complete remission after hepatectomy to the time of recurrence or cutoff for follow-up

    Measured: 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

  8. Improved quality of life

    Patients completed EORTC QLQ-C30 at various time points

    Measured: 1 month postoperative/3 months postoperative/6 months postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2024
  2. Study start1 Nov 2023
  3. Primary completion31 Jan 2025 (estimated)
  4. Study completion30 Jul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
106 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06278701
Sponsor's protocol ID
2024-003-01
Status last verified
Feb 2024
First submitted
5 Feb 2024
Last updated
26 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

    PubMed 33538338

  • Allemani C, Matsuda T, Di Carlo V, Harewood R, Matz M, Niksic M, Bonaventure A, Valkov M, Johnson CJ, Esteve J, Ogunbiyi OJ, Azevedo E Silva G, Chen WQ, Eser S, Engholm G, Stiller CA, Monnereau A, Woods RR, Visser O, Lim GH, Aitken J, Weir HK, Coleman MP; CONCORD Working Group. Global surveillance of trends in cancer survival 2000-14 (CONCORD-3): analysis of individual records for 37 513 025 patients diagnosed with one of 18 cancers from 322 population-based registries in 71 countries. Lancet. 2018 Mar 17;391(10125):1023-1075. doi: 10.1016/S0140-6736(17)33326-3. Epub 2018 Jan 31.

    PubMed 29395269

  • Tsilimigras DI, Bagante F, Sahara K, Moris D, Hyer JM, Wu L, Ratti F, Marques HP, Soubrane O, Paredes AZ, Lam V, Poultsides GA, Popescu I, Alexandrescu S, Martel G, Workneh A, Guglielmi A, Hugh T, Aldrighetti L, Endo I, Pawlik TM. Prognosis After Resection of Barcelona Clinic Liver Cancer (BCLC) Stage 0, A, and B Hepatocellular Carcinoma: A Comprehensive Assessment of the Current BCLC Classification. Ann Surg Oncol. 2019 Oct;26(11):3693-3700. doi: 10.1245/s10434-019-07580-9. Epub 2019 Jul 2.

    PubMed 31267302

  • Finn RS, Ikeda M, Zhu AX, Sung MW, Baron AD, Kudo M, Okusaka T, Kobayashi M, Kumada H, Kaneko S, Pracht M, Mamontov K, Meyer T, Kubota T, Dutcus CE, Saito K, Siegel AB, Dubrovsky L, Mody K, Llovet JM. Phase Ib Study of Lenvatinib Plus Pembrolizumab in Patients With Unresectable Hepatocellular Carcinoma. J Clin Oncol. 2020 Sep 10;38(26):2960-2970. doi: 10.1200/JCO.20.00808. Epub 2020 Jul 27.

    PubMed 32716739

  • Liu PH, Hsu CY, Hsia CY, Lee YH, Huang YH, Chiou YY, Lin HC, Huo TI. Surgical Resection Versus Radiofrequency Ablation for Single Hepatocellular Carcinoma </= 2 cm in a Propensity Score Model. Ann Surg. 2016 Mar;263(3):538-45. doi: 10.1097/SLA.0000000000001178.

    PubMed 25775062

  • Borhofen SM, Gerner C, Lehmann J, Fimmers R, Gortzen J, Hey B, Geiser F, Strassburg CP, Trebicka J. The Royal Free Hospital-Nutritional Prioritizing Tool Is an Independent Predictor of Deterioration of Liver Function and Survival in Cirrhosis. Dig Dis Sci. 2016 Jun;61(6):1735-43. doi: 10.1007/s10620-015-4015-z. Epub 2016 Jan 2.

    PubMed 26725059

  • Rong W, Xia H, Zhang K, Zhang Y, Tao C, Wu F, Wang L, Zhang H, Sun G, Wu J. Serum metabolic effects of corn oligopeptides with 7-day supplementation on early post-surgery primary liver cancer patients: a double-blind randomized controlled trial. Hepatobiliary Surg Nutr. 2022 Dec;11(6):834-847. doi: 10.21037/hbsn-21-116.

    PubMed 36523946

  • Weimann A, Braga M, Carli F, Higashiguchi T, Hubner M, Klek S, Laviano A, Ljungqvist O, Lobo DN, Martindale RG, Waitzberg D, Bischoff SC, Singer P. ESPEN practical guideline: Clinical nutrition in surgery. Clin Nutr. 2021 Jul;40(7):4745-4761. doi: 10.1016/j.clnu.2021.03.031. Epub 2021 Apr 19.

    PubMed 34242915

  • Huang TH, Hsieh CC, Kuo LM, Chang CC, Chen CH, Chi CC, Liu CH. Malnutrition associated with an increased risk of postoperative complications following hepatectomy in patients with hepatocellular carcinoma. HPB (Oxford). 2019 Sep;21(9):1150-1155. doi: 10.1016/j.hpb.2019.01.003. Epub 2019 Feb 11.

    PubMed 30765200

  • Puri P, Dhiman RK, Taneja S, Tandon P, Merli M, Anand AC, Arora A, Acharya SK, Benjamin J, Chawla YK, Dadhich S, Duseja A, Eapan CE, Goel A, Kalra N, Kapoor D, Kumar A, Madan K, Nagral A, Pandey G, Rao PN, Saigal S, Saraf N, Saraswat VA, Saraya A, Sarin SK, Sharma P, Shalimar, Shukla A, Sidhu SS, Singh N, Singh SP, Srivastava A, Wadhawan M. Nutrition in Chronic Liver Disease: Consensus Statement of the Indian National Association for Study of the Liver. J Clin Exp Hepatol. 2021 Jan-Feb;11(1):97-143. doi: 10.1016/j.jceh.2020.09.003. Epub 2020 Oct 1.

    PubMed 33679050

  • Joliat GR, Kobayashi K, Hasegawa K, Thomson JE, Padbury R, Scott M, Brustia R, Scatton O, Tran Cao HS, Vauthey JN, Dincler S, Clavien PA, Wigmore SJ, Demartines N, Melloul E. Guidelines for Perioperative Care for Liver Surgery: Enhanced Recovery After Surgery (ERAS) Society Recommendations 2022. World J Surg. 2023 Jan;47(1):11-34. doi: 10.1007/s00268-022-06732-5. Epub 2022 Oct 30.

    PubMed 36310325

  • Plauth M, Bernal W, Dasarathy S, Merli M, Plank LD, Schutz T, Bischoff SC. ESPEN guideline on clinical nutrition in liver disease. Clin Nutr. 2019 Apr;38(2):485-521. doi: 10.1016/j.clnu.2018.12.022. Epub 2019 Jan 16.

    PubMed 30712783

  • Amodio P, Bemeur C, Butterworth R, Cordoba J, Kato A, Montagnese S, Uribe M, Vilstrup H, Morgan MY. The nutritional management of hepatic encephalopathy in patients with cirrhosis: International Society for Hepatic Encephalopathy and Nitrogen Metabolism Consensus. Hepatology. 2013 Jul;58(1):325-36. doi: 10.1002/hep.26370. Epub 2013 May 31.

    PubMed 23471642

  • Leoni L, Valoriani F, Barbieri R, Pambianco M, Vinciguerra M, Sicuro C, Colecchia A, Menozzi R, Ravaioli F. Unlocking the Power of Late-Evening Snacks: Practical Ready-to-Prescribe Chart Menu for Patients with Cirrhosis. Nutrients. 2023 Aug 5;15(15):3471. doi: 10.3390/nu15153471.

    PubMed 37571408

  • Guo YJ, Tian ZB, Jiang N, Ding XL, Mao T, Jing X. Effects of Late Evening Snack on Cirrhotic Patients: A Systematic Review and Meta-Analysis. Gastroenterol Res Pract. 2018 Apr 1;2018:9189062. doi: 10.1155/2018/9189062. eCollection 2018.

    PubMed 29805447

Questions about this trial

What is this clinical trial studying?

A study testing late-evening snacks in people with Liver Neoplasms, run by DU Yao at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Albumin rising (time frame: Day 1 of admission/Post-operative day 6/1 month postoperative/3 months postoperative/6 months postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06278701, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in