Nutrition Disorders
Conditions
Keywords
umbilical cord blood transplantation, nutrition intervention
Brief summary
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.
Detailed description
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.
Interventions
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 theFive-step nutritional treatment principle, individual nutritional prescriptions were designed by clinical nutritionists.
Sponsors
Anhui Provincial Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-65 years old, conscious, with language communication skills; * UCBT patients to be performed; * Major organs without serious dysfunction; * The participants agreed to participate in the study and signed the informed consent form.
Exclusion criteria
* Age \< 18 years old or \> 65 years old or with cognitive impairment can not complete this survey; * Failure or recurrence of transplantation; * Combined with severe other organ system diseases (such as severe cardiac insufficiency, autoimmune disease, active infection, severe trauma) ; * Patients who have difficulty collecting data to complete the nutritional intervention; * Patients who asked to withdraw from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Grip strength | before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation. | The grip strength (kg) |
| Prealbumin level | before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation. | The level of prealbumin (mg/L) |
| Albumin Level | before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation. | The level of Alb (g/L) |
| The body mass index | 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). |
| The calf circumference | before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation. | The calf circumference (cm) |
| The thickness of skinfold | before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation. | thickness of skinfold (mm) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of complications | 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. |
| Hospitalization Costs | 12 months after transplantation | expenses of hospitalization |
| Overall survival (OS) | 12 months after transplantation | OS was calculated from the date of transplantation to death or last follow-up. |
| Disease-free survival (DFS) | 12 months after transplantation | DFS was defined as the time from transplantation to relapse or death from any cause. |
| The cumulative incidence of relapse (CIR) | 12 months after transplantation | Relapse and death were considered to be competing events when calculating CIR and NRM . |
| Non-Relapse Mortality (NRM) | 12 months after transplantation | Relapse and death were considered to be competing events when calculating CIR and NRM . |
| Hospitalization Duration | 12 months after transplantation | Hospitalization Duration |
Countries
China
Contacts
Primary ContactXiaoyu Zhu, Ph.D
Backup ContactLijuan Ning, M.D
Outcome results
None listed