The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital
Hefei, Anhui, 230041, China
NCT Number: NCT06553274
Based on the nutritional factor prediction model, the individualized nutritional management of patients with umbilical cord blood transplantation (UCBT) was carried out to observe the impact on the survival efficacy of patients.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Phase 2
Hefei, Anhui, 230041, China
The data of 80 UCBT patients were analyzed retrospectively, and the influence of nutritional parameters on the clinical outcome of UCBT patients was first confirmed, the skinfold thickness ≥20.5 mm and peripheral blood Alb < 33.6 g/L at 30 days after transplantation were the independent influencing factors of OS and DFS. In order to further verify the accuracy of the survival prediction model, the center intends to base on the model and aim at the nutritional parameters of patients 30 days after transplantation, a single-arm, single-center, phase II, prospective intervention trial was conducted to explore individualized nutrition management in UCBT patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
After the patients were enrolled, they were given nutritional assessment by full-time clinical nutritionist and designed individualized nutritional management program, which included: Nutritional Assessment once a week for 4 weeks after Transplantation + 30 days, and nutritional assessment once a week for 4 weeks after Transplantation + 60 days, nutritional assessment every 2 weeks for 8 weeks; nutritional assessment every 4 weeks for 1 year after Transplantation + 120 days after transplantation; nutritional assessment during hospitalization in the ward and after discharge from the hospital, they were followed up in the nutrition counseling clinic or by telephone. The total energy intake was 25-35 kcal/kg/d and the protein intake was 1.2-1.5 g/kg/d. According to the"Five-step nutritional treatment principle", individual nutritional prescriptions were designed by clinical nutritionists.
Time frame: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.
Body Mass Index (BMI) is defined as a person's weight in kilograms divided by the square of their height in meters (kg/m²).
Time frame: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.
The calf circumference (cm)
Time frame: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.
thickness of skinfold (mm)
Time frame: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.
The grip strength (kg)
Time frame: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.
The level of prealbumin (mg/L)
Time frame: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.
The level of Alb (g/L)
Time frame: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.
Incidence of acute graft-versus-host disease (GVHD), incidence of chronic GVHD, incidence of oral mucositis and rate of infection.
Time frame: 12 months after transplantation
OS was calculated from the date of transplantation to death or last follow-up.
Time frame: 12 months after transplantation
DFS was defined as the time from transplantation to relapse or death from any cause.
Time frame: 12 months after transplantation
Relapse and death were considered to be competing events when calculating CIR and NRM .
Time frame: 12 months after transplantation
Relapse and death were considered to be competing events when calculating CIR and NRM .
Time frame: 12 months after transplantation
Hospitalization Duration
Time frame: 12 months after transplantation
expenses of hospitalization
Contact information is provided by the study sponsor or research team.
Lijuan Ning, M.D
CONTACT
Xiaoyu Zhu, Ph.D
CONTACT
Anhui Provincial Hospital
Other Gov
Effect of Nutritional Intervention Based on Predictive Model of Nutritional Factors on Survival of Adult Umbilical Cord Blood Transplantation Patients
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