Nutrition DisordersPhase 2NCT06553274
Effect of Nutritional Intervention Based on Prediction Model on Adult Umbilical Cord Blood Transplantation Patients
A Phase 2 study testing Individualized nutrition intervention in people with Nutrition Disorders, run by Anhui Provincial Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nutrition Disorders
- What is being tested?
- Individualized nutrition intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteChina
- Study dates
- Aug 2024to Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital
Hefei, Anhui, 230041
Xiaoyu Zhu, 15255456091, xiaoyuz@ustc.edu.cn
Lijuan Ning, 13866106561, ninglijuan621@126.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Nutrition Disorders
- Being tested
- Individualized nutrition intervention
- Keywords
- umbilical cord blood transplantation, nutrition intervention
- Medical subject headings
- Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized nutrition interventionProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Individualized nutrition intervention | Experimental | Full-time clinical nutrition pharmacists evaluate the nutritional status of enrolled patients and design individualized nutrition management programs Receives: Procedure: Individualized nutrition intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.
The calf circumference
The calf circumference (cm)
Measured: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.
The thickness of skinfold
thickness of skinfold (mm)
Measured: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.
Grip strength
The grip strength (kg)
Measured: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.
Prealbumin level
The level of prealbumin (mg/L)
Measured: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.
Albumin Level
The level of Alb (g/L)
Measured: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.
Secondary outcomes (7)
Incidence of complications
Incidence of acute graft-versus-host disease (GVHD), incidence of chronic GVHD, incidence of oral mucositis and rate of infection.
Measured: 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.
Measured: 12 months after transplantation
Disease-free survival (DFS)
DFS was defined as the time from transplantation to relapse or death from any cause.
Measured: 12 months after transplantation
The cumulative incidence of relapse (CIR)
Relapse and death were considered to be competing events when calculating CIR and NRM .
Measured: 12 months after transplantation
Non-Relapse Mortality (NRM)
Relapse and death were considered to be competing events when calculating CIR and NRM .
Measured: 12 months after transplantation
Hospitalization Duration
Hospitalization Duration
Measured: 12 months after transplantation
Hospitalization Costs
expenses of hospitalization
Measured: 12 months after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study startAug 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition DisordersStudies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Xiaoyu Zhu, Ph.D, Principal investigator, The First Affiliated Hospital of University of Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553274
- Sponsor's protocol ID
- Nutrition-2024
- Status last verified
- Aug 2024
- First submitted
- 5 Aug 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nutritional Intervention Based on Predictive Model of Nutritional Factors on Survival of Adult Umbilical Cord Blood Transplantation Patients
- ClinicalTrials.gov ID
- NCT06553274
- Acronym / sponsor ID
- Nutrition-2024
- Conditions
- Nutrition Disorders
- Keywords
- umbilical cord blood transplantation, nutrition intervention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- Aug 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 14 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Individualized nutrition intervention | Experimental | Procedure: Individualized nutrition interventionFull-time clinical nutrition pharmacists evaluate the nutritional status of enrolled patients and design individualized nutrition management programs |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized nutrition interventionAfter 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. | Procedure or surgery | Individualized nutrition intervention |
Primary outcome
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).
The calf circumference
Time frame: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.
The calf circumference (cm)
The thickness of skinfold
Time frame: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.
thickness of skinfold (mm)
Grip strength
Time frame: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.
The grip strength (kg)
Prealbumin level
Time frame: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.
The level of prealbumin (mg/L)
Albumin Level
Time frame: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.
The level of Alb (g/L)
7 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoyu Zhu, Ph.D principal investigator
The First Affiliated Hospital of University of Science and Technology of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Individualized nutrition intervention in people with Nutrition Disorders, run by Anhui Provincial Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoyu Zhu, Ph.D (15255456091, xiaoyuz@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The body mass index (time frame: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.