- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04591340
Effect of Standardized Nutrient Management on Clinical Outcomes of Hematopoientic Stem Cell Transportation Patients
October 9, 2020 updated by: The Third Xiangya Hospital of Central South University
Effect of Standardized Nutrient Management on Clinical Outcomes of Hematopoientic Stem Cell Transportation Patients--a Cross-sectional Study
To analysis a standardized stepped nutritional treatment process for patients with hematopoietic stem cell transportation, including nutritional risk screening and assessment, standardized nutritional treatment implementation, therapeutic effect follow-up and monitoring, family nutritional treatment follow-up, etc
Study Overview
Status
Unknown
Conditions
Detailed Description
Standardized nutrition therapy for patients with hematopoietic stem cell transportation should follow the principle of sequential treatment of nutrition, which is the preferred scheme with individualized dietary advice or oral nutritional supplement, if their energy intake will not reach 60% of the goal level during the transplanting, then supplementary parenteral nutrition or total parenteral nutrition is needed.
The standardized nutrition therapy aims to improve quality of life and long-term survival rate of patients, reduce the complications and social burden of disease.
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hunan
-
Changsha, Hunan, China, 410013
- Recruiting
- Feng
-
Contact:
- Min Liu
- Phone Number: 86-731-88618717
- Email: Liumin330@hotmail.com
-
Contact:
- Guo Feng
- Phone Number: 86-731-88618717
- Email: fgblood@csu.edu.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 66 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Both female and male patients and between 10 to 79 years old treated with HSCT can be included.
Description
Inclusion Criteria:
- • Patients treated with HSCT
Exclusion Criteria:
- nothing
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
test group
all the patients treated with HSCT are with nutrition risk, so they will be all included to accept nutrition therapy.
|
All HSCT(hematopoietic stem cell transplantation) patients should be accepted dietary advice or oral nutritional supplement, if their energy intake will not reach 60% of the goal level during the transplanting, then supplementary parenteral nutrition or total parenteral nutrition.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Improvement of nutritional status
Time Frame: 4 months
|
We collect the body composition and grip strength of every HSCTpatients.
Body composition include the muscle and fat contents.They are all measured as kilogram.
(kg).
Specific nutritional guidelines will be provided based on body composition results
|
4 months
|
|
Improvement of quality of life
Time Frame: 4 months
|
We asked each patient to complete the quality of life scale for every HSCTpatient.
There are 32 questions in the scale, and each question has 4-7 options.
The higher the score, the heavier it is.We will decide whether to give psychological intervention based on the score.
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 1, 2021
Primary Completion (Anticipated)
December 31, 2021
Study Completion (Anticipated)
July 1, 2022
Study Registration Dates
First Submitted
October 9, 2020
First Submitted That Met QC Criteria
October 9, 2020
First Posted (Actual)
October 19, 2020
Study Record Updates
Last Update Posted (Actual)
October 19, 2020
Last Update Submitted That Met QC Criteria
October 9, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- YYK-2020003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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