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Not yet recruiting NCT06553274

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

Phase II Interventional Nutrition Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Individualized nutrition intervention.
Who it may be relevant to
Registry conditions: Nutrition Disorders. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • 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

Primary outcome measures

  • The body mass index [Time frame: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.]
  • The calf circumference [Time frame: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.]
  • The thickness of skinfold [Time frame: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.]
  • Grip strength [Time frame: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.]
  • Prealbumin level [Time frame: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.]
  • Albumin Level [Time frame: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.]
Secondary outcome measures (7)
  • Incidence of complications [Time frame: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.]
  • Overall survival (OS) [Time frame: 12 months after transplantation]
  • Disease-free survival (DFS) [Time frame: 12 months after transplantation]
  • The cumulative incidence of relapse (CIR) [Time frame: 12 months after transplantation]
  • Non-Relapse Mortality (NRM) [Time frame: 12 months after transplantation]
  • Hospitalization Duration [Time frame: 12 months after transplantation]
  • Hospitalization Costs [Time frame: 12 months after transplantation]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital of University of Science and Technology of China (Anhui Prov — Hefei

Identifiers

NCT: NCT06553274 · Nutrition-2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗