Clinical trial NCT06553274: Effect of Nutritional Intervention Based on Prediction Model on Adult Umbilical Cord Blood Transplantation Patients
Official title: Effect of Nutritional Intervention Based on Predictive Model of Nutritional Factors on Survival of Adult Umbilical Cord Blood Transplantation Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Nutrition Disorders
Keywords: umbilical cord blood transplantation
nutrition intervention
Lead sponsor: Anhui Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2024-08-14
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

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.

Primary outcomes:
measure: The body mass index
timeFrame: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.
measure: The calf circumference
timeFrame: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.
measure: The thickness of skinfold
timeFrame: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.
measure: Grip strength
timeFrame: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.
measure: Prealbumin level
timeFrame: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.
measure: Albumin Level
timeFrame: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.
Secondary outcomes:
measure: Incidence of complications
timeFrame: before transplantation, Day30 , Day 60 , Day120 , Day180, 12 months after transplantation.
measure: Overall survival (OS)
timeFrame: 12 months after transplantation
measure: Disease-free survival (DFS)
timeFrame: 12 months after transplantation
measure: The cumulative incidence of relapse (CIR)
timeFrame: 12 months after transplantation
measure: Non-Relapse Mortality (NRM)
timeFrame: 12 months after transplantation
measure: Hospitalization Duration
timeFrame: 12 months after transplantation
measure: Hospitalization Costs
timeFrame: 12 months after transplantation
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital
state: Anhui
Study officials:
affiliation: The First Affiliated Hospital of University of Science and Technology of China
name: Xiaoyu Zhu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: