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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individualized nutrition intervention | Experimental | Full-time clinical nutrition pharmacists evaluate the nutritional status of enrolled patients and design individualized nutrition management programs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individualized nutrition intervention | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The body mass index | Body Mass Index (BMI) is defined as a person's weight in kilograms divided by the square of their height in meters (kg/m²). | before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation. |
| The calf circumference | The calf circumference (cm) | before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation. |
| The thickness of skinfold | thickness of skinfold (mm) | before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation. |
| Grip strength | The grip strength (kg) | before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation. |
| Prealbumin level | The level of prealbumin (mg/L) | before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation. |
| Albumin Level | The level of Alb (g/L) | before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of complications | Incidence of acute graft-versus-host disease (GVHD), incidence of chronic GVHD, incidence of oral mucositis and rate of infection. | before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation. |
| Overall survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoyu Zhu, Ph.D | Contact | 15255456091 | xiaoyuz@ustc.edu.cn | |
| Lijuan Ning, M.D | Contact | 13866106561 | ninglijuan621@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoyu Zhu, Ph.D | The First Affiliated Hospital of University of Science and Technology of China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital | Hefei | Anhui | 230041 | China |
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| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
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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.
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OS was calculated from the date of transplantation to death or last follow-up. |
| 12 months after transplantation |
| Disease-free survival (DFS) | DFS was defined as the time from transplantation to relapse or death from any cause. | 12 months after transplantation |
| The cumulative incidence of relapse (CIR) | Relapse and death were considered to be competing events when calculating CIR and NRM . | 12 months after transplantation |
| Non-Relapse Mortality (NRM) | Relapse and death were considered to be competing events when calculating CIR and NRM . | 12 months after transplantation |
| Hospitalization Duration | Hospitalization Duration | 12 months after transplantation |
| Hospitalization Costs | expenses of hospitalization | 12 months after transplantation |