Nutritional Status of Patients After Hematopoietic Stem Cell Transplantation

Sponsor
The First Affiliated Hospital of Soochow University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04146870
Collaborator
(none)
200
1
51
3.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Survey of Nutritional Status of Patients After Hematopoietic Stem Cell Transplantation
Actual Study Start Date :
Oct 1, 2018
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Outcome Measures

Primary Outcome Measures

  1. 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)

  2. 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)

  3. 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

  4. Change from Baseline albumin level in blood at 6 months [6 months]

    The content of albumin in blood is determined.

Secondary Outcome Measures

  1. 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

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The first affiliated hospital of suzhou university Suzhou Jiangsu China 215000

Sponsors and Collaborators

  • The First Affiliated Hospital of Soochow University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sheng-Li Xue, MD, Associate Professor, The First Affiliated Hospital of Soochow University
ClinicalTrials.gov Identifier:
NCT04146870
Other Study ID Numbers:
  • SZnutri01
First Posted:
Oct 31, 2019
Last Update Posted:
Apr 12, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 12, 2022