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NCT Number: NCT06549829

the Effect of Nutrition-optimized Prehabilitation on Perioperative Intervention in Primary Liver Carcinoma

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. 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 month postoperatively.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, 310009, China

Location status: Recruiting

Location contact

Human Subject Research Ethics Committee

CONTACT

[email protected]

+86 0571 87783759

About this study

Study subgroups: experimental group (nutritional optimization-led triple prehabilitation), control group (conventional triple prerehabilitation) , with a 1:2 allocation ratio between experimental and control groups.

  • Enrollment Criteria ①Patients diagnosed with primary liver cancer.

②Patients between 18 and 80 years old.

③ Patients who are feasible for surgical treatment after clinical evaluation.

  • 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. ④ Patients with severe malnutrition that cannot be corrected by oral nutrition. ⑤ Patients with hyperthyroidism, fistula, and combined digestive system diseases.
  • 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.

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.

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with primary liver cancer.
  • Patients between the ages of 18 and 80.
  • Patients who are feasible for surgical treatment after clinical evaluation.

Exclusion criteria

  • 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.

Treatment and study plan

Nutritional optimization-led triple prehabilitation Intervention

Other

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.

Conventional triple prehabilitation Intervention

Other

Conventional triple prehabilitation: ordinary dietary supplementation; exercise workouts focused on increasing lung capacity and cardiorespiratory tolerance; specialized psychological interventions.

Primary outcomes

  1. Postoperative serum prealbumin decline from baseline

    Time frame: One day after surgery

    peripheral blood

Secondary outcomes

  1. Postoperative Six-minute walk test (6MWT)

    Time frame: One week after surgery

    walk test for six minutes

  2. Postoperative serum prealbumin

    Time frame: One day after surgery

    peripheral blood

  3. Postoperative albumin

    Time frame: One day after surgery

    peripheral blood

  4. Postoperative retinol-binding protein

    Time frame: One day after surgery

    peripheral blood

Other outcomes

  1. Drainage tube removal time

    Time frame: Postoperative, an average of 3 days

    remove abdominal drainage

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, Zhejiang University, School of Medicine

Other

Collaborators

  • Shangrao People's Hospital
  • ZhuZhou Central Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 12, 2024
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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