Nutritional Status of Patients After Hematopoietic Stem Cell Transplantation

Recruiting

• Conditions: Nutrition; Hematopoietic Stem Cell Transplantation

• Registration Number: NCT04146870
• Lead Sponsor: The First Affiliated Hospital of Soochow University

Brief Summary

The main objectives of this study were :(1) to comprehensively and systematically evaluate the nutritional status of patients after hematopoietic stem cell transplantation. (2) to explore the effect of nutritional factors on the prognosis of patients treated by hematopoietic stem cell transplantation.

Detailed Description

This study is devised to investigate nutritional status in patients who have undergone hematopoietic stem cell transplantation in the First Affiliated Hospital of Soochow University. Evaluation time points include the day before receiving conditioning regimen, post-transplantation 180 days, the nutritional status of patients were systematically evaluated from the aspects of food intake, physical activity level, body composition, blood biochemistry, etc. Also, the effect of nutritional factors on prognosis of hematopoietic stem cell transplantaion patients will be evaluated.

Study Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2019-10-14
• Study First Submitted QC: 2019-10-30
• Study First Posted: 2019-10-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-17
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients who undergo hematopoietic stem cell transplantation in the First Affiliated Hospital of Soochow University.
• Having a life expectancy of more than 3 months

Exclusion Criteria

• Not willing to participate in the investigation
• Age less than 15 years old or more than 80 years old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from Baseline food intake at 6 months	6 months	24-hour dietary record and semi-quantitative food frequency questionnaire are used to evaluate the eating condition of patients
Change from Baseline fat mass at 6 months	6 months	Body composition analyzer INBODY S10 (bioelectrical impedance method) is used to analyze the content of fat mass（ kilograms）
Change from Baseline fat free mass at 6 months	6 months	Body composition analyzer INBO DY S10 (bioelectrical impedance method) is used to analyze the content of fat free mass（ kilograms）
Change from Baseline albumin level in blood at 6 months	6 months	The content of albumin in blood is determined.

Secondary Outcome Measures

Name	Time	Method
Overall survial	3 years	It is measured from the date of entry into this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive
Event free survival	3 years	It is measured from the date of entry into this trial to the date of relapse from CR, or CRi, or death from any cause; patients not known to have any of these events are censored on the date they were last examined.

Trial Locations

Locations (1)

The first affiliated hospital of suzhou university; 🇨🇳 Suzhou, Jiangsu, China