Nutrition Related CancerNCT04591340
Effect of Standardized Nutrient Management on Clinical Outcomes of Hematopoientic Stem Cell Transportation Patients
An observational study of Nutrition Related Cancer, run by The Third Xiangya Hospital of Central South University at 1 site in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 10 to 70 years
- Conditions the study is for
- Nutrition Related Cancer
- What is being tested?
- dietary advice, oral nutritional supplement, supplementary parenteral nutrition or total parenteral nutrition
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 1 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Both female and male patients and between 10 to 79 years old treated with HSCT can be included.
Who may be able to join
- • Patients treated with HSCT
Who cannot join
- nothing
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Feng
Changsha, Hunan, 410013
Min Liu, 86-731-88618717, Liumin330@hotmail.com
Guo Feng, 86-731-88618717, fgblood@csu.edu.cn
About this study
Official title: 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
Read the 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.
- Conditions
- Nutrition Related Cancer
- Being tested
- dietary advice, oral nutritional supplement, supplementary parenteral nutrition or total parenteral nutrition
- Keywords
- HSCT; Nutrtion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary advice, oral nutritional supplement, supplementary parenteral nutrition or total parenteral nutritionDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| test group | all the patients treated with HSCT are with nutrition risk, so they will be all included to accept nutrition therapy. Receives: Dietary Supplement: dietary advice, oral nutritional supplement, supplementary parenteral nutrition or total parenteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of nutritional status
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
Measured: 4 months
Improvement of quality of life
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Jan 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition Related CancerStudies of the same condition, open and under way.
- More trials run by The Third Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591340
- Sponsor's protocol ID
- YYK-2020003
- Status last verified
- Sep 2020
- First submitted
- 9 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Standardized Nutrient Management on Clinical Outcomes of Hematopoientic Stem Cell Transportation Patients--a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04591340
- Acronym / sponsor ID
- YYK-2020003
- Conditions
- Nutrition Related Cancer
- Keywords
- HSCT; Nutrtion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| test group | – | Dietary Supplement: dietary advice, oral nutritional supplement, supplementary parenteral nutrition or total parenteral nutritionall the patients treated with HSCT are with nutrition risk, so they will be all included to accept nutrition therapy. |
Who may qualify
- Ages
- 10 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Both female and male patients and between 10 to 79 years old treated with HSCT can be included.
Key inclusion criteria (1 listed)
- • Patients treated with HSCT
Key exclusion criteria (1 listed)
- nothing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dietary advice, oral nutritional supplement, supplementary parenteral nutrition or total parenteral nutritionAll 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. | Dietary supplement | test group |
Primary outcome
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutrition Related Cancer, run by The Third Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of nutritional status (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.