The Effect of Nutrition-optimized Prehabilitation on Perioperative Intervention in Primary Hepatocellular Carcinoma

February 5, 2025 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

Nutrition-Optimized Prehabilitation's Impact on Perioperative Outcomes in Primary Hepatocellular Carcinoma: a Randomized Controlled Trial

The aim of this project is to investigate the effect of triple prehabilitation led by nutritional optimization in liver cancer patients' surgery. It improves the preoperative nutritional status of cancer patients, reduces the incidence of early postoperative complications, promotes postoperative recovery, and improves the quality of patients' survival. Patients were randomized into experimental and control groups based on exclusion and inclusion criteria. Nutritional interventions and exercise and psychological interventions for patients. Interventions will continue for two weeks prior to surgery. Routine clinical blood tests will be performed at the time of enrollment, on the first day before surgery and on the first, third and fifth days after surgery. Enrolled patients were followed up by telephone or outpatient clinic at 1,3,6 months postoperatively.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Study subgroups: experimental group (nutritional optimization-led triple prehabilitation), control group (conventional triple prerehabilitation)

  1. Enrollment Criteria

    ①Patients diagnosed with primary liver cancer.

    • Patients between 18 and 70 years old.

      • Patients who are feasible for surgical treatment after clinical evaluation. ④Major organ function meets the following conditions: neutrophil count >1.5*109/L /L; platelet count >100* 109/L; hemoglobin >90g/L; transaminase and creatinine <twice the upper limit.

  2. Exclusion criteria

    • Patients with liver metastases or combined with other tumors. ② Patients with allergy to the ingredients of nutritional preparations.

      • Patients who cannot eat by mouth.

        • Patients with severe malnutrition that cannot be corrected by oral nutrition. ⑤ Patients with hyperthyroidism, fistula, and combined digestive system diseases.

  3. Intervention measures The nutritional status of the patients was assessed together with the clinical nutritionist to develop an individualized nutritional plan. The experimental group used normal dietary supplementation + oral nutritional supplementation, and the control group used normal dietary supplementation. Target energy was defined as basal energy metabolism level*physical activity level, which was 1.55 for men and 1.56 for women; basal energy level was defined as basal metabolism standard value*body weight. Depending on the patient, a 20% increase in energy intake is calculated on top of the target energy. One scoop of oral nutritional powder has an energy of 27.5kcal, and the dose of nutritional powder needed is calculated from the increased energy intake value. The required amount of powder should be taken orally in 200ml of warm water three times a day, and the exact time of taking the powder should be customized according to the patient's condition.

    Other interventions:

    A personalized exercise program was developed with the rehabilitation physician, and the experimental and control groups underwent exercise to increase lung capacity and cardiorespiratory tolerance: respiratory exercise was included: the patients were guided to learn to cough and cough up sputum with deep breaths before the operation, and the respiratory trainer was used to carry out bedside training. The patients were instructed to learn to cough and cough up sputum with deep breaths before surgery. Exercise planning: aerobic exercise (jogging or walking) three times a day for 15 minutes.

    The experimental group and the control group underwent psychiatric intervention: patients were psychologically evaluated according to the Hospital Anxiety and Depression Scale (HADS), and the scores of the anxiety and depression subscales were as follows: 0-7 was negative; 8-10 was mild; 11-14 was moderate; and 15-21 was severe. Patients with anxiety tendencies were counseled at least three times during the preoperative week and given medication if necessary. At the same time, the patients were guided to self-psychological counseling: no less than 15 minutes before bedtime every day.At the same time, patients were guided to self-help psychological guidance: every day before bedtime, they should listen to soothing music for at least 15 minutes, which was provided by the project team.

    Intervention time: Nutritional, exercise and psychological interventions will continue for two weeks before surgery. Nutritional, exercise and psychological interventions will continue for two weeks before surgery.

    The patients will undergo routine clinical blood tests at the time of enrollment, 1 day before the operation and the 1st, 3rd and 5th days after the operation.

  4. Follow-up The patients will be followed up by telephone or outpatient clinic at 1, 3, and 6 months after the operation; the patients' clinical data will be recorded.

The relevant clinical data during the process will be recorded.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients diagnosed with primary liver cancer.

    • Patients between the ages of 18 and 70.

      • Patients who are feasible for surgical treatment after clinical evaluation. ④Major organ function meets the following conditions: neutrophil count >1.5*109/L; platelet count >100* 109/L; hemoglobin >90g/L; transaminase and creatinine <twice the upper limit.

Exclusion Criteria:

  • Patients with liver metastases or combined with other tumors. ②Patients with allergy to the ingredients of nutritional preparations.

    • Patients with severe malnutrition who cannot eat by mouth. ④Patients with hyperthyroidism, fistula, and combined digestive system diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nutritional optimization-led triple prehabilitation Intervention
Nutritional optimization-led triple prehabilitation
Other: Nutritional optimization-led triple prehabilitation Intervention
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 + transoral nutritional supplementation, and the control group used ordinary dietary supplementation. The target energy was basal energy metabolism level * physical activity level, physical activity level was male: 1.55 female: 1.56; basal energy level was basal metabolism standardized value * body weight (basal metabolism standardized value for obese patients was 25; basal metabolism standardized value for normal or emaciated patients was 30). Add 600kcal capacity supplement to this. Exercise workouts focused on increasing lung capacity and cardiorespiratory tolerance. Specialized psychological interventions.
Other: Conventional triple prehabilitation Intervention
Conventional triple prehabilitation
Other: Conventional triple prehabilitation Intervention
Conventional triple prehabilitation: ordinary dietary supplementation; exercise workouts focused on increasing lung capacity and cardiorespiratory tolerance; specialized psychological interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative serum prealbumin
Time Frame: One day after surgery, three days after surgery, five days after surgery
peripheral blood
One day after surgery, three days after surgery, five days after surgery
Postoperative transferrin
Time Frame: One day after surgery, three days after surgery, five days after surgery
peripheral blood
One day after surgery, three days after surgery, five days after surgery
Postoperative retinol-binding protein
Time Frame: One day after surgery, three days after surgery, five days after surgery
peripheral blood
One day after surgery, three days after surgery, five days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Six-minute walk test (6MWT)
Time Frame: One week after surgery
walk test for six minutes
One week after surgery
grading and incidence of various types of complications
Time Frame: one month after surgery
complications grade and incidence
one month after surgery
postoperative length of stay
Time Frame: stay hospital time, an average of 10 days
stay hospital time
stay hospital time, an average of 10 days
30-day readmission rate
Time Frame: postoperative for 30 days
readmission rate
postoperative for 30 days
patient long-term quality of life indicators (6 months)
Time Frame: during postoperative for 6 month
life quality
during postoperative for 6 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drainage tube removal time
Time Frame: Postoperative, an average of 3 days
remove abdominal drainage
Postoperative, an average of 3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Study Chair: Yuan Ding, Second Affiliated Hospital, School of Medicine, Zhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

May 13, 2024

First Submitted That Met QC Criteria

August 8, 2024

First Posted (Actual)

August 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 5, 2025

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-0344

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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