Ignite Creation Date:
2024-10-25 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06549829
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-05-13
Brief Title:
the Effect of Nutrition-optimized Prehabilitation on Perioperative Intervention in Primary Hepatocellular Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Nutrition-Optimized Prehabilitations Impact on Perioperative Outcomes in Primary Hepatocellular Carcinoma A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 136 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 15109L L platelet count 100 109L hemoglobin 90gL 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 levelphysical activity level which was 155 for men and 156 for women basal energy level was defined as basal metabolism standard valuebody 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 275kcal 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 patients 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 dayAt 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
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 15109L L platelet count 100 109L hemoglobin 90gL 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 levelphysical activity level which was 155 for men and 156 for women basal energy level was defined as basal metabolism standard valuebody 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 275kcal 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 patients 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 dayAt 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None