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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAnhui Provincial Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Individualized nutrition intervention

    Procedure/Surgery

    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.

Treatment groups

67 Participants
are divided into 1 treatment group
Group A: Individualized nutrition interventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.
2

The calf circumference

The calf circumference (cm)

Time frame
before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.
3

The thickness of skinfold

thickness of skinfold (mm)

Time frame
before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.
4

Grip strength

The grip strength (kg)

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

Secondary outcomes

1

Incidence of complications

Incidence of acute graft-versus-host disease (GVHD), incidence of chronic GVHD, incidence of oral mucositis and rate of infection.

Time frame
before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.
2

Overall survival (OS)

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

Time frame
12 months after transplantation
3

Disease-free survival (DFS)

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

Time frame
12 months after transplantation
4

The cumulative incidence of relapse (CIR)

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

Time frame
12 months after transplantation

Other outcomes

Sponsors and contacts

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