Nutritional Status of Patients After Hematopoietic Stem Cell Transplantation

A Survey of Nutritional Status of Patients After Hematopoietic Stem Cell Transplantation

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.

Study Overview

• Status: Recruiting
• Conditions: Hematopoietic Stem Cell Transplantation; Nutrition
• Intervention / Treatment: Other: not have

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Sheng-Li Xue, M.D.; Phone Number: +86 512 67781139; Email: slxue@suda.edu.cn

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215000
      • Recruiting
      • The First Affiliated Hospital of Suzhou University
      • Contact: Sheng-Li Xue, M.D.; Phone Number: +86 512 67781139; Email: slxue@suda.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients who have received hematopoietic stem cell transplantation in the First Affiliated Hospital of Soochow University

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survial	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	3 years
Event free survival	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.	3 years

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Soochow University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: October 14, 2019
• First Submitted That Met QC Criteria: October 30, 2019
• First Posted (Actual): October 31, 2019

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: SZnutri01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No