Effect of Nutritional Intervention Based on Prediction Model on Adult Umbilical Cord Blood Transplantation Patients

Effect of Nutritional Intervention Based on Predictive Model of Nutritional Factors on Survival of Adult Umbilical Cord Blood Transplantation Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Nutrition Disorders
• Intervention / Treatment: Procedure: Individualized nutrition intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 67
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xiaoyu Zhu, Ph.D; Phone Number: 15255456091; Email: xiaoyuz@ustc.edu.cn
• Study Contact Backup: Name: Lijuan Ning, M.D; Phone Number: 13866106561; Email: ninglijuan621@126.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230041
      • The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital
      • Contact: Xiaoyu Zhu; Phone Number: 15255456091; Email: xiaoyuz@ustc.edu.cn
      • Contact: Lijuan Ning; Phone Number: 13866106561; Email: ninglijuan621@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Individualized nutrition intervention; Full-time clinical nutrition pharmacists evaluate the nutritional status of enrolled patients and design individualized nutrition management programs

Procedure: Individualized nutrition intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Anhui Provincial Hospital
• Investigators: Principal Investigator: Xiaoyu Zhu, Ph.D, The First Affiliated Hospital of University of Science and Technology of China

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 5, 2024
• First Submitted That Met QC Criteria: August 11, 2024
• First Posted (Actual): August 14, 2024

Study Record Updates

• Last Update Posted (Actual): August 14, 2024
• Last Update Submitted That Met QC Criteria: August 11, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: nutrition intervention; umbilical cord blood transplantation
• Additional Relevant MeSH Terms: Nutrition Disorders
• Other Study ID Numbers: Nutrition-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No