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Trial Title:
the Effect of Nutrition-optimized Prehabilitation on Perioperative Intervention in Primary Hepatocellular Carcinoma
NCT ID:
NCT06549829
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Nutritional optimization-led triple prehabilitation Intervention
Description:
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.
Arm group label:
Nutritional optimization-led triple prehabilitation Intervention
Intervention type:
Other
Intervention name:
Conventional triple prehabilitation Intervention
Description:
Conventional triple prehabilitation: ordinary dietary supplementation; exercise workouts
focused on increasing lung capacity and cardiorespiratory tolerance; specialized
psychological interventions.
Arm group label:
Conventional triple prehabilitation Intervention
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
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Start date:
September 2024
Completion date:
January 2026
Lead sponsor:
Agency:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency class:
Other
Source:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06549829
