Effect of Nutritional Intervention Based on Prediction Model on Adult Umbilical Cord Blood Transplantation Patients
- Conditions
- Nutrition Disorders
- Interventions
- Procedure: Individualized nutrition intervention
- Registration Number
- NCT06553274
- Lead Sponsor
- Anhui Provincial Hospital
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 67
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Individualized nutrition intervention Individualized nutrition intervention Full-time clinical nutrition pharmacists evaluate the nutritional status of enrolled patients and design individualized nutrition management programs
- Primary Outcome Measures
Name Time Method The thickness of skinfold before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation. thickness of skinfold (mm)
Grip strength before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation. The grip strength (kg)
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).
Albumin Level before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation. The level of Alb (g/L)
The calf circumference before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation. The calf circumference (cm)
Prealbumin level before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation. The level of prealbumin (mg/L)
- Secondary Outcome Measures
Name Time Method 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.
Non-Relapse Mortality (NRM) 12 months after transplantation Relapse and death were considered to be competing events when calculating CIR and NRM .
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.
The cumulative incidence of relapse (CIR) 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
Trial Locations
- Locations (1)
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital
🇨🇳Hefei, Anhui, China