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NCT Number: NCT06553274

Effect of Nutritional Intervention Based on Prediction Model on 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. The body mass index

    Time frame: 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).

  2. The calf circumference

    Time frame: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.

    The calf circumference (cm)

  3. The thickness of skinfold

    Time frame: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.

    thickness of skinfold (mm)

  4. Grip strength

    Time frame: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.

    The grip strength (kg)

  5. Prealbumin level

    Time frame: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.

    The level of prealbumin (mg/L)

  6. Albumin Level

    Time frame: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.

    The level of Alb (g/L)

Secondary outcomes

  1. Incidence of complications

    Time frame: 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.

  2. Overall survival (OS)

    Time frame: 12 months after transplantation

    OS was calculated from the date of transplantation to death or last follow-up.

  3. Disease-free survival (DFS)

    Time frame: 12 months after transplantation

    DFS was defined as the time from transplantation to relapse or death from any cause.

  4. The cumulative incidence of relapse (CIR)

    Time frame: 12 months after transplantation

    Relapse and death were considered to be competing events when calculating CIR and NRM .

  5. Non-Relapse Mortality (NRM)

    Time frame: 12 months after transplantation

    Relapse and death were considered to be competing events when calculating CIR and NRM .

  6. Hospitalization Duration

    Time frame: 12 months after transplantation

    Hospitalization Duration

  7. Hospitalization Costs

    Time frame: 12 months after transplantation

    expenses of hospitalization

Study contacts

Contact information is provided by the study sponsor or research team.

Lijuan Ning, M.D

CONTACT

[email protected]

13866106561

Xiaoyu Zhu, Ph.D

CONTACT

[email protected]

15255456091

Sponsors and collaborators

Lead sponsor

Anhui Provincial Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 14, 2024
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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