Hepatocellular CarcinomaNCT06549829
the Effect of Nutrition-optimized Prehabilitation on Perioperative Intervention in Primary Liver Carcinoma
A study testing Nutritional optimization-led triple prehabilitation Intervention and Conventional triple prehabilitation Intervention in people with Hepatocellular Carcinoma and Liver Carcinoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 3 sites in China.
Trial summary
This study aimed to evaluate whether nutritional optimization-led triple prehabilitation could improve perioperative nutritional status, promote postoperative recovery, and reduce postoperative complications in patients with primary liver cancer undergoing surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Carcinoma, Hepatobiliary Cancers
- What is being tested?
- Nutritional optimization-led triple prehabilitation Intervention and Conventional triple prehabilitation Intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 3 sitesChina
- Study dates
- 10 May 2024to 29 Sep 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with primary liver cancer.
- Patients between the ages of 18 and 80.
- Patients who are feasible for surgical treatment after clinical evaluation.
Who cannot join
- Patients with liver metastases or combined with other tumors.
- Patients with allergy to the ingredients of nutritional preparations. ③Patients with severe malnutrition who cannot eat by mouth. ④Patients with hyperthyroidism, fistula, and combined digestive system diseases.
Trial locations and contacts
3 sites in 1 country.
China3 sites
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, 310009
Huzhou Central Hospital
Huzhou, Zhejiang, 313000
ShangRao People's Hospital
Shangrao, Jiangxi, 334000
About this study
Official title: Nutrition-Optimized Prehabilitation's Impact on Perioperative Outcomes in Primary Liver Carcinoma: A Randomized Controlled Trial
This study aimed to evaluate whether nutritional optimization-led triple prehabilitation could improve perioperative nutritional status, promote postoperative recovery, and reduce postoperative complications in patients with primary liver cancer undergoing surgery. After screening according to the inclusion and exclusion criteria, eligible patients were randomized into experimental and control groups. Both groups received exercise and psychological interventions; for nutritional intervention, the experimental group received an ordinary diet plus oral nutritional supplementation, whereas the control group received an ordinary diet alone. Routine clinical blood tests were performed at the time of enrollment and on the first, third and fifth days after surgery. Enrolled patients were followed up by telephone or outpatient clinic at 1 month postoperatively.
Read the detailed description
Study subgroups: experimental group (nutritional optimization-led triple prehabilitation), control group (conventional triple prehabilitation) , with a 1:2 allocation ratio between experimental and control groups.
Intervention measures The nutritional status of each participant will be assessed in collaboration with a clinical nutritionist to develop an individualized nutritional plan. The experimental group will receive oral nutritional supplementation (ONS; Ensure) in addition to their usual diet, whereas the control group will receive their usual diet alone.
Resting energy expenditure (REE) will be estimated using the revised Harris-Benedict equations:
Men: REE (kcal/day) = 88.362 + 13.397W + 4.799H - 5.677A Women: REE (kcal/day) = 447.593 + 9.247W + 3.098H - 4.330A where W is body weight (kg), H is height (cm), and A is age (years). The estimated daily energy requirement will be calculated as REE * 1.3 (activity factor) * 1.2 (stress factor). Assuming a usual dietary energy intake of approximately 1,600 kcal/day, the additional energy to be supplied by ONS will be calculated by subtracting 1,600 kcal from the estimated daily energy requirement. Ensure powder provides 4.50 kcal/g; therefore, the required daily amount of powder will be calculated by dividing the additional energy requirement by 4.50 kcal/g.
The calculated daily amount of Ensure powder will be divided into three doses, each dissolved in 200 mL of warm water and taken orally between meals. Adherence will be monitored by the nursing team and clinical nutritionist, who will record actual supplement intake. The intervention will begin at enrollment and continue until the day before surgery.
Other interventions:
A personalized exercise program will be developed with the rehabilitation physician, and both groups will undergo exercise to increase lung capacity and cardiorespiratory tolerance: respiratory exercise will be included - patients will be guided to learn to cough and cough up sputum with deep breaths before the operation, and a respiratory trainer will be used for bedside training.
Exercise planning: in addition to respiratory training, patients will perform aerobic exercise (jogging or walking) and resistance exercise (dumbbells or resistance bands), with intensity and frequency individualized according to baseline fitness.
The experimental and control groups will undergo psychiatric intervention: patients will be psychologically evaluated with the Hospital Anxiety and Depression Scale (HADS), together with the Fatigue Assessment Scale (FAS). Those with elevated anxiety or depression (HADS ≥ 11) will receive psychological counseling 3-5 times during the preoperative week and medication when necessary, and will be guided to listen to soothing music for at least 15 minutes before bedtime daily.
The patients will undergo routine clinical blood tests at the time of enrollment and the 1st, 3rd and 5th days after the operation.
Follow-up The patients will be followed up by telephone or outpatient clinic at 1 month after the operation; the patients' clinical data will be recorded.
The relevant clinical data during the process will be recorded.
- Being tested
- Nutritional optimization-led triple prehabilitation Intervention, Conventional triple prehabilitation Intervention
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional optimization-led triple prehabilitation InterventionOther
The nutritional status of the patients was assessed together with the clinical nutritionist to develop an individualized nutritional plan. The experimental group used ordinary dietary supplementation + oral nutritional supplementation, and the control group used ordinary dietary supplementation. The target energy was calculated as resting energy expenditure (REE, revised Harris-Benedict [Shizgal-Rosa] equation) × 1.3 (activity factor) × 1.2 (stress factor), and the oral nutritional supplement dose was (target energy - 1,600 kcal) ÷ 4.50 kcal/g. Exercise workouts focused on increasing lung capacity and cardiorespiratory tolerance. Specialized psychological interventions.
Conventional triple prehabilitation InterventionOther
Conventional triple prehabilitation: ordinary dietary supplementation; exercise workouts focused on increasing lung capacity and cardiorespiratory tolerance; specialized psychological interventions.
| Study group | Role | What they receive |
|---|---|---|
| Nutritional optimization-led triple prehabilitation Intervention | Experimental | Nutritional optimization-led triple prehabilitation Receives: Other: Nutritional optimization-led triple prehabilitation Intervention |
| Conventional triple prehabilitation Intervention | Other | Conventional triple prehabilitation Receives: Other: Conventional triple prehabilitation Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum prealbumin concentration from baseline to postoperative day 1
peripheral blood
Measured: From baseline to postoperative day 1
Secondary outcomes (4)
6-minute walk distance (meters)
walk test for six minutes（6MWT）
Measured: One week after surgery
Postoperative serum prealbumin Concentration
peripheral blood
Measured: One day after surgery
Postoperative Serum Albumin Concentration
peripheral blood
Measured: One day after surgery
Postoperative Serum Retinol-Binding Protein Concentration
peripheral blood
Measured: One day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start10 May 2024
- Primary completion1 Sep 2026
- Study completion29 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shangrao People's Hospital, Huzhou Central Hospital
- Responsible party
- Sponsor
- Investigators
- Yuan Ding, Study chair, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06549829
- Sponsor's protocol ID
- 2024-0344
- Status last verified
- Oct 2026
- First submitted
- 13 May 2024
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin Y, Zheng L, Fang K, Zheng Y, Wu J, Zheng M. Proportion of liver cancer cases and deaths attributable to potentially modifiable risk factors in China. Int J Epidemiol. 2023 Dec 25;52(6):1805-1814. doi: 10.1093/ije/dyad100.
PubMed 37431632Zhou YM, Zhang XF, Li B, Sui CJ, Yang JM. Postoperative complications affect early recurrence of hepatocellular carcinoma after curative resection. BMC Cancer. 2015 Oct 14;15:689. doi: 10.1186/s12885-015-1720-0.
PubMed 26466573Noba L, Rodgers S, Chandler C, Balfour A, Hariharan D, Yip VS. Enhanced Recovery After Surgery (ERAS) Reduces Hospital Costs and Improve Clinical Outcomes in Liver Surgery: a Systematic Review and Meta-Analysis. J Gastrointest Surg. 2020 Apr;24(4):918-932. doi: 10.1007/s11605-019-04499-0. Epub 2020 Jan 3.
PubMed 31900738Forsmo HM, Pfeffer F, Rasdal A, Sintonen H, Korner H, Erichsen C. Pre- and postoperative stoma education and guidance within an enhanced recovery after surgery (ERAS) programme reduces length of hospital stay in colorectal surgery. Int J Surg. 2016 Dec;36(Pt A):121-126. doi: 10.1016/j.ijsu.2016.10.031. Epub 2016 Oct 22.
PubMed 27780772Davis JF, van Rooijen SJ, Grimmett C, West MA, Campbell AM, Awasthi R, Slooter GD, Grocott MP, Carli F, Jack S. From Theory to Practice: An International Approach to Establishing Prehabilitation Programmes. Curr Anesthesiol Rep. 2022;12(1):129-137. doi: 10.1007/s40140-022-00516-2. Epub 2022 Feb 18.
PubMed 35194410
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition-Optimized Prehabilitation's Impact on Perioperative Outcomes in Primary Liver Carcinoma: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06549829
- Acronym / sponsor ID
- 2024-0344
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Shangrao People's Hospital, Huzhou Central Hospital
- Study start
- 10 May 2024 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 29 Sep 2026 (actual)
- First posted
- 12 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to evaluate whether nutritional optimization-led triple prehabilitation could improve perioperative nutritional status, promote postoperative recovery, and reduce postoperative complications in patients with primary liver cancer undergoing surgery. After screening according to the inclusion and exclusion criteria, eligible patients were randomized into experimental and control groups. Both groups received exercise and psychological interventions; for nutritional intervention, the experimental group received an ordinary diet plus oral nutritional supplementation, whereas the control group received an ordinary diet alone. Routine clinical blood tests were performed at the time of enrollment and on the first, third and fifth days after surgery. Enrolled patients were followed up by telephone or outpatient clinic at 1 month postoperatively.
Detailed description
Study subgroups: experimental group (nutritional optimization-led triple prehabilitation), control group (conventional triple prehabilitation) , with a 1:2 allocation ratio between experimental and control groups.
Intervention measures The nutritional status of each participant will be assessed in collaboration with a clinical nutritionist to develop an individualized nutritional plan. The experimental group will receive oral nutritional supplementation (ONS; Ensure) in addition to their usual diet, whereas the control group will receive their usual diet alone.
Resting energy expenditure (REE) will be estimated using the revised Harris-Benedict equations:
Men: REE (kcal/day) = 88.362 + 13.397W + 4.799H - 5.677A Women: REE (kcal/day) = 447.593 + 9.247W + 3.098H - 4.330A where W is body weight (kg), H is height (cm), and A is age (years). The estimated daily energy requirement will be calculated as REE * 1.3 (activity factor) * 1.2 (stress factor). Assuming a usual dietary energy intake of approximately 1,600 kcal/day, the additional energy to be supplied by ONS will be calculated by subtracting 1,600 kcal from the estimated daily energy requirement. Ensure powder provides 4.50 kcal/g; therefore, the required daily amount of powder will be calculated by dividing the additional energy requirement by 4.50 kcal/g.
The calculated daily amount of Ensure powder will be divided into three doses, each dissolved in 200 mL of warm water and taken orally between meals. Adherence will be monitored by the nursing team and clinical nutritionist, who will record actual supplement intake. The intervention will begin at enrollment and continue until the day before surgery.
Other interventions:
A personalized exercise program will be developed with the rehabilitation physician, and both groups will undergo exercise to increase lung capacity and cardiorespiratory tolerance: respiratory exercise will be included - patients will be guided to learn to cough and cough up sputum with deep breaths before the operation, and a respiratory trainer will be used for bedside training.
Exercise planning: in addition to respiratory training, patients will perform aerobic exercise (jogging or walking) and resistance exercise (dumbbells or resistance bands), with intensity and frequency individualized according to baseline fitness.
The experimental and control groups will undergo psychiatric intervention: patients will be psychologically evaluated with the Hospital Anxiety and Depression Scale (HADS), together with the Fatigue Assessment Scale (FAS). Those with elevated anxiety or depression (HADS ≥ 11) will receive psychological counseling 3-5 times during the preoperative week and medication when necessary, and will be guided to listen to soothing music for at least 15 minutes before bedtime daily.
The patients will undergo routine clinical blood tests at the time of enrollment and the 1st, 3rd and 5th days after the operation.
Follow-up The patients will be followed up by telephone or outpatient clinic at 1 month after the operation; the patients' clinical data will be recorded.
The relevant clinical data during the process will be recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional optimization-led triple prehabilitation Intervention | Experimental | Other: Nutritional optimization-led triple prehabilitation InterventionNutritional optimization-led triple prehabilitation |
| Conventional triple prehabilitation Intervention | Other | Other: Conventional triple prehabilitation InterventionConventional triple prehabilitation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with primary liver cancer.
Key exclusion criteria (2 listed)
- Patients with liver metastases or combined with other tumors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional optimization-led triple prehabilitation InterventionThe nutritional status of the patients was assessed together with the clinical nutritionist to develop an individualized nutritional plan. The experimental group used ordinary dietary supplementation + oral nutritional supplementation, and the control group used ordinary dietary supplementation. The target energy was calculated as resting energy expenditure (REE, revised Harris-Benedict [Shizgal-Rosa] equation) × 1.3 (activity factor) × 1.2 (stress factor), and the oral nutritional supplement dose was (target energy - 1,600 kcal) ÷ 4.50 kcal/g. Exercise workouts focused on increasing lung capacity and cardiorespiratory tolerance. Specialized psychological interventions. | Other | Nutritional optimization-led triple prehabilitation Intervention |
| Conventional triple prehabilitation InterventionConventional triple prehabilitation: ordinary dietary supplementation; exercise workouts focused on increasing lung capacity and cardiorespiratory tolerance; specialized psychological interventions. | Other | Conventional triple prehabilitation Intervention |
Primary outcome
Change in serum prealbumin concentration from baseline to postoperative day 1
Time frame: From baseline to postoperative day 1
peripheral blood
4 secondary outcomes
6-minute walk distance (meters)
Time frame: One week after surgery
Postoperative serum prealbumin Concentration
Time frame: One day after surgery
Postoperative Serum Albumin Concentration
Time frame: One day after surgery
Postoperative Serum Retinol-Binding Protein Concentration
Time frame: One day after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Background: PubMed 37431632Lin Y, Zheng L, Fang K, Zheng Y, Wu J, Zheng M. Proportion of liver cancer cases and deaths attributable to potentially modifiable risk factors in China. Int J Epidemiol. 2023 Dec 25;52(6):1805-1814. doi: 10.1093/ije/dyad100.
- Background: PubMed 26466573Zhou YM, Zhang XF, Li B, Sui CJ, Yang JM. Postoperative complications affect early recurrence of hepatocellular carcinoma after curative resection. BMC Cancer. 2015 Oct 14;15:689. doi: 10.1186/s12885-015-1720-0.
- Background: PubMed 31900738Noba L, Rodgers S, Chandler C, Balfour A, Hariharan D, Yip VS. Enhanced Recovery After Surgery (ERAS) Reduces Hospital Costs and Improve Clinical Outcomes in Liver Surgery: a Systematic Review and Meta-Analysis. J Gastrointest Surg. 2020 Apr;24(4):918-932. doi: 10.1007/s11605-019-04499-0. Epub 2020 Jan 3.
- Background: PubMed 27780772Forsmo HM, Pfeffer F, Rasdal A, Sintonen H, Korner H, Erichsen C. Pre- and postoperative stoma education and guidance within an enhanced recovery after surgery (ERAS) programme reduces length of hospital stay in colorectal surgery. Int J Surg. 2016 Dec;36(Pt A):121-126. doi: 10.1016/j.ijsu.2016.10.031. Epub 2016 Oct 22.
- Background: PubMed 35194410Davis JF, van Rooijen SJ, Grimmett C, West MA, Campbell AM, Awasthi R, Slooter GD, Grocott MP, Carli F, Jack S. From Theory to Practice: An International Approach to Establishing Prehabilitation Programmes. Curr Anesthesiol Rep. 2022;12(1):129-137. doi: 10.1007/s40140-022-00516-2. Epub 2022 Feb 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuan Ding study chair
Second Affiliated Hospital, Zhejiang University, School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional optimization-led triple prehabilitation Intervention and Conventional triple prehabilitation Intervention in people with Hepatocellular Carcinoma and Liver Carcinoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 3 sites 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in serum prealbumin concentration from baseline to postoperative day 1 (time frame: From baseline to postoperative day 1). 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 NCT06549829, which also lists 5 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 4 Nov 2026.