Clinical trial NCT06549829: The Effect of Nutrition-optimized Prehabilitation on Perioperative Intervention in Primary Hepatocellular Carcinoma
Official title: Nutrition-Optimized Prehabilitation's Impact on Perioperative Outcomes in Primary Hepatocellular Carcinoma: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatocellular Carcinoma
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative serum prealbumin
timeFrame: One day after surgery, three days after surgery, five days after surgery
measure: Postoperative transferrin
timeFrame: One day after surgery, three days after surgery, five days after surgery
measure: Postoperative retinol-binding protein
timeFrame: One day after surgery, three days after surgery, five days after surgery
Secondary outcomes:
measure: Postoperative Six-minute walk test (6MWT)
timeFrame: One week after surgery
measure: grading and incidence of various types of complications
timeFrame: one month after surgery
measure: postoperative length of stay
timeFrame: stay hospital time, an average of 10 days
measure: 30-day readmission rate
timeFrame: postoperative for 30 days
measure: patient long-term quality of life indicators (6 months)
timeFrame: during postoperative for 6 month
Other outcomes:
measure: Drainage tube removal time
timeFrame: Postoperative, an average of 3 days
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Yuan Ding
role: STUDY_CHAIR
References:
citation: 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.
citation: Zhou 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.
citation: Noba 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.
citation: Forsmo 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.
citation: Davis 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.