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

August 11, 2024 updated by: Anhui Provincial Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
67

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230041
        • The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
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 calf circumference (cm)
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.
thickness of skinfold (mm)
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.
The grip strength (kg)
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.
The level of prealbumin (mg/L)
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.
The level of Alb (g/L)
before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.
Overall survival (OS)
Time Frame: 12 months after transplantation
OS was calculated from the date of transplantation to death or last follow-up.
12 months after transplantation
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.
12 months after transplantation
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 .
12 months after transplantation
Non-Relapse Mortality (NRM)
Time Frame: 12 months after transplantation
Relapse and death were considered to be competing events when calculating CIR and NRM .
12 months after transplantation
Hospitalization Duration
Time Frame: 12 months after transplantation
Hospitalization Duration
12 months after transplantation
Hospitalization Costs
Time Frame: 12 months after transplantation
expenses of hospitalization
12 months after transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Anhui Provincial Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xiaoyu Zhu, Ph.D, The First Affiliated Hospital of University of Science and Technology of China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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