Nutrition Aspect of CancerNCT05590091
Study on Intelligent Nutrition Support Therapy for Hematopoietic Stem Cell Transplantation Recipients
A study testing Parenteral nutrition;Enteral nutrition in people with Nutrition Aspect of Cancer and Stem Cell Transplant Complications, run by Hebei Yanda Ludaopei Hospital.
Trial summary
The use of high-dose radiotherapy, chemotherapy and preventive antibiotics in the preconditioning regimen before allogeneic hematopoietic stem cell transplantation can easily lead to damage to the gastrointestinal mucosa, resulting in malnutrition, and even progression to cachexia, which directly leads to multiple… Read more about this study
- Who is it for?
- Ages 12 to 55 years
- Conditions the study is for
- Nutrition Aspect of Cancer, Stem Cell Transplant Complications
- What is being tested?
- Parenteral nutrition;Enteral nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2022to 31 Mar 2024
- Phase
- Interventional
- 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 12 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 12-55 years old;
- Patients who are about to receive allo-HSCT (1-2 weeks before pretreatment);
- No serious medical and surgical complications, no mental and psychological diseases;
- Those who voluntarily participate in the research and sign the informed consent.
- No serious allergic diseases, especially those with milk protein allergy
Who cannot join
- Feeling unwell during the test;
- Combined with severe infection or other serious underlying diseases, the duration of hemodynamic instability is ≥5 days;
- Severe liver and kidney dysfunction and coagulation disorder for ≥5 days;
- Intractable cachexia/refractory stage: the tumor continues to progress and does not respond to treatment; the catabolism is active, and the body weight continues to lose weight that cannot be corrected
- Clinical symptoms of brain dysfunction or severe mental illness, unable to understand or comply with the research protocol;
- Drug abuse, medical, psychological or social conditions that may interfere with the subject's participation in the research or the evaluation of the research results;
- Those who cannot be followed up as scheduled;
- The investigator believes that the subjects have any clinical or laboratory abnormalities or compliance problems and are not suitable to participate in this clinical study
About this study
Official title: Allogeneic Hematopoietic Stem Cell Transplantation Based on the Support of Intelligent Nutrition Management System Nutritional Intervention Research in Recipients During Peritransplantation
The use of high-dose radiotherapy, chemotherapy and preventive antibiotics in the preconditioning regimen before allogeneic hematopoietic stem cell transplantation can easily lead to damage to the gastrointestinal mucosa, resulting in malnutrition, and even progression to cachexia, which directly leads to multiple organ failure; The damage of the intestinal mucosal barrier, secondary to the translocation of intestinal-derived bacteria, leads to bloodstream infection and lung infection (drug-resistant Enterobacteriaceae, especially carbapenem-resistant Enterobacteriaceae infection) is one of the challenges faced in clinical treatment. A major problem that affects the long-term survival rate of patients. Nutrition therapy based on the support and guidance of the intelligent nutrition management system aims to improve the adherence and compliance rate of patients with nutritional support therapy through scientific and accurate monitoring and intervention, thereby improving the nutritional status of patients and improving the tolerance of patients to radiotherapy and chemotherapy， and reduce the incidence of adverse reactions. At the same time, it is expected that nutritional support therapy will protect the integrity of the intestinal mucosal barrier of patients, reduce the incidence of enterobacteriaceae bacterial infections (mainly drug-resistant Klebsiella pneumoniae and Escherichia coli infections), and ultimately improve the long-term survival rate. Purpose.
This trial objects are patients who are going to undergo allogeneic hematopoietic stem cell transplantation, and explores the use of intelligent nutrition management system for data support to reduce the incidence and severity of malnutrition, especially cachexia, and to help reduce the incidence and severity of Enterobacteriaceae bacterial infections. It can reduce the incidence of acute intestinal GVHD and ultimately improve the long-term survival rate and quality of life of patients.
Read the detailed description
- Background The use of high-dose radiotherapy, chemotherapy and preventive antibiotics in the preconditioning regimen before allogeneic hematopoietic stem cell transplantation can easily lead to damage to the gastrointestinal mucosa, resulting in malnutrition, and even progression to cachexia, which directly leads to multiple organ failure; The damage of the intestinal mucosal barrier, secondary to the translocation of intestinal-derived bacteria, leads to bloodstream infection and lung infection (drug-resistant Enterobacteriaceae, especially carbapenem-resistant Enterobacteriaceae infection) is one of the challenges faced in clinical treatment. A major problem that affects the long-term survival rate of patients. Nutrition therapy based on the support and guidance of the intelligent nutrition management system aims to improve the compliance and compliance rate of patients with nutritional support therapy through scientific and accurate monitoring and intervention, thereby improving the nutritional status of patients and improving the tolerance of patients to radiotherapy and chemotherapy. Reduce the incidence of adverse reactions. At the same time, it is hoped that nutritional support therapy will protect the integrity of the intestinal mucosal barrier of patients, reduce the incidence of Enterobacteriaceae bacterial infections (mainly drug-resistant Klebsiella pneumoniae and Escherichia coli infections), and ultimately improve the long-term survival rate.
- Purposes To investigate the effect of continuous nutritional therapy on the nutritional status of allogeneic HSCT recipients based on an intelligent nutritional management system, and to reduce the incidence of malnutrition during peri-transplantation.
- Conditions to be met to participate in a study/trial Inclusion criteria: 1. Age 12-55 years old; 2. Patients who are about to receive allo-HSCT (1-2 weeks before pretreatment) ; 3. No serious medical and surgical complications, no mental and psychological diseases; 4. . Those who voluntarily participate in the study and sign the informed consent in writing. 4. No serious allergic diseases, especially those with milk protein allergy; Exclusion criteria: 1. Physical discomfort during the test; 2. Complicated with severe infection or other serious underlying diseases, and the duration of hemodynamic instability is ≥5 days; 3. Severe liver and kidney dysfunction and coagulation disorders persist Time ≥ 5 days; 4. Intractable cachexia phase/refractory phase: tumor continues to progress, no response to treatment; catabolism is active, and body weight continues to lose weight that cannot be corrected 5. Being unable to understand or comply with the research protocol due to clinical symptoms of brain dysfunction or severe mental illness; 6. drug abuse, medical, psychological or social conditions that may interfere with the subject's participation in the research or the evaluation of the research results; 7. Those who cannot be followed up as scheduled; 8. The investigator believes that the subject has any clinical or laboratory abnormalities or compliance problems that are not suitable for participation in this clinical study.
- Number of trail subjects This clinical trial is a randomized controlled trial, and plans to recruit a total of 106 subjects, with 53 subjects in the experimental group and 53 in the control group .
- Research/Trial Process This study is a randomized controlled clinical trial. After signing the informed consent, the subjects who meet the inclusion and exclusion criteria will be randomly assigned to the experimental group and the control group at a ratio of 1:1. The control group only receives conventional treatment, while the experimental group receives precise nutritional intervention with the assistance of an intelligent nutrition system. The intervention period of the experimental group will be 100 days after being enrolled and receiving the transplantation. The patients in the control group and experimental group will be followed up at -5d before transplantation and +6d, +30d, +60d, +100d, +180d, and +360d after transplantation. .
Randomized trial : The grouping is randomly performed by the computer, so that the bias caused by the grouping can be avoided. Each subject had a 50% chance of being assigned to both the experimental group and the control group.
- Being tested
- Parenteral nutrition;Enteral nutrition
- Keywords
- HSCT, Nutrition therapy, Intestinal graft-versus-host disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenteral nutrition;Enteral nutritionOther
The intelligent nutrition management system was used to carry out standardized nutrition management of patients after hematopoietic stem cell transplantation
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | roup A were given precise dietary guidance and enteral and parenteral nutrition support treatment using only nutrition software. It is recommended that the precise recommended time covers the start of enrollment until 100 days after transplantation Receives: Other: Parenteral nutrition;Enteral nutrition |
| The control group | No intervention | Group B patients were given the routine nutritional support treatment plan commonly used in clinics. Patients in both groups were monitored and followed up at -5d before transplantation and at +6d, +30d, +60d, +100d, +180d, and +360d after transplantation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who fell sick and vomit at certain checkpoint of transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of sick and vomit and statistics the number of participants who developed these symptoms
Measured: 5 days before transplantation
Number of participants who fell sick and vomit at certain checkpoint of transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of sick and vomit and statistics the number of participants who developed these symptoms
Measured: 6 days after transplantation
Number of participants who fell sick and vomit at certain checkpoint of transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of sick and vomit and statistics the number of participants who developed these symptoms
Measured: 30 days after transplantation
Number of participants who fell sick and vomit at certain checkpoint of transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of sick and vomit and statistics the number of participants who developed these symptoms
Measured: 60 days after transplantation
Number of participants who fell sick and vomit at certain checkpoint of transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of sick and vomit and statistics the number of participants who developed these symptoms
Measured: 100 days after transplantation
Number of participants who fell sick and vomit at certain checkpoint of transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of sick and vomit and statistics the number of participants who developed these symptoms
Measured: 180 days after transplantation
Number of participants who fell sick and vomit at certain checkpoint of transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of sick and vomit and statistics the number of participants who developed these symptoms
Measured: 360 days after transplantation
Number of participants who fell constipate at certain checkpoint of transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of constipate and statistics the number of participants who developed these symptoms
Measured: 5 days before transplantation
Number of participants who fell constipate at certain checkpoint of transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of constipate and statistics the number of participants who developed these symptoms
Measured: 6 days after transplantation
Number of participants who fell constipate at certain checkpoint of transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of constipate and statistics the number of participants who developed these symptoms
Measured: 30 days after transplantation
Number of participants who fell constipate at certain checkpoint of transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of constipate and statistics the number of participants who developed these symptoms
Measured: 60 days after transplantation
Number of participants who fell constipate at certain checkpoint of transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of constipate and statistics the number of participants who developed these symptoms
Measured: 100 days after transplantation
Number of participants who fell constipate at certain checkpoint of transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of constipate and statistics the number of participants who developed these symptoms
Measured: 180 days after transplantation
Number of participants who fell constipate at certain checkpoint of transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of constipate and statistics the number of participants who developed these symptoms
Measured: 360 days after transplantation
Number of participants who fell difficulty urinating at certain checkpoint of transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of difficulty urinating and statistics the number of participants who developed these symptoms
Measured: 5 days before transplantation
Number of participants who fell difficulty urinating at certain checkpoint of transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of difficulty urinating and statistics the number of participants who developed these symptoms
Measured: 6 days after transplantation
Number of participants who fell difficulty urinating at certain checkpoint of transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of difficulty urinating and statistics the number of participants who developed these symptoms
Measured: 30 days after transplantation
Number of participants who fell difficulty urinating at certain checkpoint of transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of difficulty urinating and statistics the number of participants who developed these symptoms
Measured: 60 days after transplantation
Number of participants who fell difficulty urinating at certain checkpoint of transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of difficulty urinating and statistics the number of participants who developed these symptoms
Measured: 100 days after transplantation
Number of participants who fell difficulty urinating at certain checkpoint of transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of difficulty urinating and statistics the number of participants who developed these symptoms
Measured: 180 days after transplantation
Number of participants who fell difficulty urinating at certain checkpoint of transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of difficulty urinating and statistics the number of participants who developed these symptoms
Measured: 360 days before transplantation
Number of participants who fell lethargy at certain checkpoint of transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of lethargy and statistics the number of participants who developed these symptoms
Measured: 5 days before transplantation
Number of participants who fell lethargy at certain checkpoint of transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of lethargy and statistics the number of participants who developed these symptoms
Measured: 6 days after transplantation
Number of participants who fell lethargy at certain checkpoint of transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of lethargy and statistics the number of participants who developed these symptoms
Measured: 30 days after transplantation
Number of participants who fell lethargy at certain checkpoint of transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of lethargy and statistics the number of participants who developed these symptoms
Measured: 60 days after transplantation
Number of participants who fell lethargy at certain checkpoint of transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of lethargy and statistics the number of participants who developed these symptoms
Measured: 100 days after transplantation
Number of participants who fell lethargy at certain checkpoint of transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of lethargy and statistics the number of participants who developed these symptoms
Measured: 180 days after transplantation
Number of participants who fell lethargy at certain checkpoint of transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of lethargy and statistics the number of participants who developed these symptoms
Measured: 360 days after transplantation
Number of participants who fell dizziness, difficulty breathing, biliary colic, headache, stomachache, or anorexia at certain checkpoint of transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of dizziness, difficulty breathing, biliary colic, headache, stomachache, or anorexia and statistics the number of participants who developed these symptoms
Measured: 5 days before transplantation
Number of participants who fell dizziness, difficulty breathing, biliary colic, headache, stomachache, or anorexia at certain checkpoint of transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of dizziness, difficulty breathing, biliary colic, headache, stomachache, or anorexia and statistics the number of participants who developed these symptoms
Measured: 6 days after transplantation
Number of participants who fell dizziness, difficulty breathing, biliary colic, headache, stomachache, or anorexia at certain checkpoint of transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of dizziness, difficulty breathing, biliary colic, headache, stomachache, or anorexia and statistics the number of participants who developed these symptoms
Measured: 30 days after transplantation
Number of participants who fell dizziness, difficulty breathing, biliary colic, headache, stomachache, or anorexia at certain checkpoint of transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of dizziness, difficulty breathing, biliary colic, headache, stomachache, or anorexia and statistics the number of participants who developed these symptoms
Measured: 60 days after transplantation
Number of participants who fell dizziness, difficulty breathing, biliary colic, headache, stomachache, or anorexia at certain checkpoint of transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of dizziness, difficulty breathing, biliary colic, headache, stomachache, or anorexia and statistics the number of participants who developed these symptoms
Measured: 100 days after transplantation
Number of participants who fell dizziness, difficulty breathing, biliary colic, headache, stomachache, or anorexia at certain checkpoint of transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of dizziness, difficulty breathing, biliary colic, headache, stomachache, or anorexia and statistics the number of participants who developed these symptoms
Measured: 180 days after transplantation
Number of participants who fell dizziness, difficulty breathing, biliary colic, headache, stomachache, or anorexia at certain checkpoint of transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of dizziness, difficulty breathing, biliary colic, headache, stomachache, or anorexia and statistics the number of participants who developed these symptoms
Measured: 360 days after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start1 Nov 2022 (estimated)
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition Aspect of CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Yanda Ludaopei Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590091
- Sponsor's protocol ID
- DPJG-Y-202205
- Status last verified
- Oct 2022
- First submitted
- 13 Sep 2022
- Last updated
- 21 Oct 2022
- Results posted
- No
- 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 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Hematopoietic Stem Cell Transplantation Based on the Support of Intelligent Nutrition Management System Nutritional Intervention Research in Recipients During Peritransplantation
- ClinicalTrials.gov ID
- NCT05590091
- Acronym / sponsor ID
- DPJG-Y-202205
- Keywords
- HSCT, Nutrition therapy, Intestinal graft-versus-host disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Hebei Yanda Ludaopei HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 21 Oct 2022 (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.
The use of high-dose radiotherapy, chemotherapy and preventive antibiotics in the preconditioning regimen before allogeneic hematopoietic stem cell transplantation can easily lead to damage to the gastrointestinal mucosa, resulting in malnutrition, and even progression to cachexia, which directly leads to multiple organ failure; The damage of the intestinal mucosal barrier, secondary to the translocation of intestinal-derived bacteria, leads to bloodstream infection and lung infection (drug-resistant Enterobacteriaceae, especially carbapenem-resistant Enterobacteriaceae infection) is one of the challenges faced in clinical treatment. A major problem that affects the long-term survival rate of patients. Nutrition therapy based on the support and guidance of the intelligent nutrition management system aims to improve the adherence and compliance rate of patients with nutritional support therapy through scientific and accurate monitoring and intervention, thereby improving the nutritional status of patients and improving the tolerance of patients to radiotherapy and chemotherapy， and reduce the incidence of adverse reactions. At the same time, it is expected that nutritional support therapy will protect the integrity of the intestinal mucosal barrier of patients, reduce the incidence of enterobacteriaceae bacterial infections (mainly drug-resistant Klebsiella pneumoniae and Escherichia coli infections), and ultimately improve the long-term survival rate. Purpose.
This trial objects are patients who are going to undergo allogeneic hematopoietic stem cell transplantation, and explores the use of intelligent nutrition management system for data support to reduce the incidence and severity of malnutrition, especially cachexia, and to help reduce the incidence and severity of Enterobacteriaceae bacterial infections. It can reduce the incidence of acute intestinal GVHD and ultimately improve the long-term survival rate and quality of life of patients.
Detailed description
- Background The use of high-dose radiotherapy, chemotherapy and preventive antibiotics in the preconditioning regimen before allogeneic hematopoietic stem cell transplantation can easily lead to damage to the gastrointestinal mucosa, resulting in malnutrition, and even progression to cachexia, which directly leads to multiple organ failure; The damage of the intestinal mucosal barrier, secondary to the translocation of intestinal-derived bacteria, leads to bloodstream infection and lung infection (drug-resistant Enterobacteriaceae, especially carbapenem-resistant Enterobacteriaceae infection) is one of the challenges faced in clinical treatment. A major problem that affects the long-term survival rate of patients. Nutrition therapy based on the support and guidance of the intelligent nutrition management system aims to improve the compliance and compliance rate of patients with nutritional support therapy through scientific and accurate monitoring and intervention, thereby improving the nutritional status of patients and improving the tolerance of patients to radiotherapy and chemotherapy. Reduce the incidence of adverse reactions. At the same time, it is hoped that nutritional support therapy will protect the integrity of the intestinal mucosal barrier of patients, reduce the incidence of Enterobacteriaceae bacterial infections (mainly drug-resistant Klebsiella pneumoniae and Escherichia coli infections), and ultimately improve the long-term survival rate.
- Purposes To investigate the effect of continuous nutritional therapy on the nutritional status of allogeneic HSCT recipients based on an intelligent nutritional management system, and to reduce the incidence of malnutrition during peri-transplantation.
- Conditions to be met to participate in a study/trial Inclusion criteria: 1. Age 12-55 years old; 2. Patients who are about to receive allo-HSCT (1-2 weeks before pretreatment) ; 3. No serious medical and surgical complications, no mental and psychological diseases; 4. . Those who voluntarily participate in the study and sign the informed consent in writing. 4. No serious allergic diseases, especially those with milk protein allergy; Exclusion criteria: 1. Physical discomfort during the test; 2. Complicated with severe infection or other serious underlying diseases, and the duration of hemodynamic instability is ≥5 days; 3. Severe liver and kidney dysfunction and coagulation disorders persist Time ≥ 5 days; 4. Intractable cachexia phase/refractory phase: tumor continues to progress, no response to treatment; catabolism is active, and body weight continues to lose weight that cannot be corrected 5. Being unable to understand or comply with the research protocol due to clinical symptoms of brain dysfunction or severe mental illness; 6. drug abuse, medical, psychological or social conditions that may interfere with the subject's participation in the research or the evaluation of the research results; 7. Those who cannot be followed up as scheduled; 8. The investigator believes that the subject has any clinical or laboratory abnormalities or compliance problems that are not suitable for participation in this clinical study.
- Number of trail subjects This clinical trial is a randomized controlled trial, and plans to recruit a total of 106 subjects, with 53 subjects in the experimental group and 53 in the control group .
- Research/Trial Process This study is a randomized controlled clinical trial. After signing the informed consent, the subjects who meet the inclusion and exclusion criteria will be randomly assigned to the experimental group and the control group at a ratio of 1:1. The control group only receives conventional treatment, while the experimental group receives precise nutritional intervention with the assistance of an intelligent nutrition system. The intervention period of the experimental group will be 100 days after being enrolled and receiving the transplantation. The patients in the control group and experimental group will be followed up at -5d before transplantation and +6d, +30d, +60d, +100d, +180d, and +360d after transplantation. .
Randomized trial : The grouping is randomly performed by the computer, so that the bias caused by the grouping can be avoided. Each subject had a 50% chance of being assigned to both the experimental group and the control group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Parenteral nutrition;Enteral nutritionroup A were given precise dietary guidance and enteral and parenteral nutrition support treatment using only nutrition software. It is recommended that the precise recommended time covers the start of enrollment until 100 days after transplantation |
| The control group | No intervention | –Group B patients were given the routine nutritional support treatment plan commonly used in clinics. Patients in both groups were monitored and followed up at -5d before transplantation and at +6d, +30d, +60d, +100d, +180d, and +360d after transplantation. |
Who may qualify
- Ages
- 12 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age 12-55 years old;
- Patients who are about to receive allo-HSCT (1-2 weeks before pretreatment);
- No serious medical and surgical complications, no mental and psychological diseases;
- Those who voluntarily participate in the research and sign the informed consent.
- No serious allergic diseases, especially those with milk protein allergy
Key exclusion criteria (8 listed)
- Feeling unwell during the test;
- Combined with severe infection or other serious underlying diseases, the duration of hemodynamic instability is ≥5 days;
- Severe liver and kidney dysfunction and coagulation disorder for ≥5 days;
- Intractable cachexia/refractory stage: the tumor continues to progress and does not respond to treatment; the catabolism is active, and the body weight continues to lose weight that cannot be corrected
- Clinical symptoms of brain dysfunction or severe mental illness, unable to understand or comply with the research protocol;
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 |
|---|---|---|
| Parenteral nutrition;Enteral nutritionThe intelligent nutrition management system was used to carry out standardized nutrition management of patients after hematopoietic stem cell transplantation | Other | Experimental group |
Primary outcome
Number of participants who fell sick and vomit at certain checkpoint of transplantation
Time frame: 5 days before transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of sick and vomit and statistics the number of participants who developed these symptoms
Number of participants who fell sick and vomit at certain checkpoint of transplantation
Time frame: 6 days after transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of sick and vomit and statistics the number of participants who developed these symptoms
Number of participants who fell sick and vomit at certain checkpoint of transplantation
Time frame: 30 days after transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of sick and vomit and statistics the number of participants who developed these symptoms
Number of participants who fell sick and vomit at certain checkpoint of transplantation
Time frame: 60 days after transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of sick and vomit and statistics the number of participants who developed these symptoms
Number of participants who fell sick and vomit at certain checkpoint of transplantation
Time frame: 100 days after transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of sick and vomit and statistics the number of participants who developed these symptoms
Number of participants who fell sick and vomit at certain checkpoint of transplantation
Time frame: 180 days after transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of sick and vomit and statistics the number of participants who developed these symptoms
Number of participants who fell sick and vomit at certain checkpoint of transplantation
Time frame: 360 days after transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of sick and vomit and statistics the number of participants who developed these symptoms
Number of participants who fell constipate at certain checkpoint of transplantation
Time frame: 5 days before transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of constipate and statistics the number of participants who developed these symptoms
Number of participants who fell constipate at certain checkpoint of transplantation
Time frame: 6 days after transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of constipate and statistics the number of participants who developed these symptoms
Number of participants who fell constipate at certain checkpoint of transplantation
Time frame: 30 days after transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of constipate and statistics the number of participants who developed these symptoms
Number of participants who fell constipate at certain checkpoint of transplantation
Time frame: 60 days after transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of constipate and statistics the number of participants who developed these symptoms
Number of participants who fell constipate at certain checkpoint of transplantation
Time frame: 100 days after transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of constipate and statistics the number of participants who developed these symptoms
Number of participants who fell constipate at certain checkpoint of transplantation
Time frame: 180 days after transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of constipate and statistics the number of participants who developed these symptoms
Number of participants who fell constipate at certain checkpoint of transplantation
Time frame: 360 days after transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of constipate and statistics the number of participants who developed these symptoms
Number of participants who fell difficulty urinating at certain checkpoint of transplantation
Time frame: 5 days before transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of difficulty urinating and statistics the number of participants who developed these symptoms
Number of participants who fell difficulty urinating at certain checkpoint of transplantation
Time frame: 6 days after transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of difficulty urinating and statistics the number of participants who developed these symptoms
Number of participants who fell difficulty urinating at certain checkpoint of transplantation
Time frame: 30 days after transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of difficulty urinating and statistics the number of participants who developed these symptoms
Number of participants who fell difficulty urinating at certain checkpoint of transplantation
Time frame: 60 days after transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of difficulty urinating and statistics the number of participants who developed these symptoms
Number of participants who fell difficulty urinating at certain checkpoint of transplantation
Time frame: 100 days after transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of difficulty urinating and statistics the number of participants who developed these symptoms
Number of participants who fell difficulty urinating at certain checkpoint of transplantation
Time frame: 180 days after transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of difficulty urinating and statistics the number of participants who developed these symptoms
Number of participants who fell difficulty urinating at certain checkpoint of transplantation
Time frame: 360 days before transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of difficulty urinating and statistics the number of participants who developed these symptoms
Number of participants who fell lethargy at certain checkpoint of transplantation
Time frame: 5 days before transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of lethargy and statistics the number of participants who developed these symptoms
Number of participants who fell lethargy at certain checkpoint of transplantation
Time frame: 6 days after transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of lethargy and statistics the number of participants who developed these symptoms
Number of participants who fell lethargy at certain checkpoint of transplantation
Time frame: 30 days after transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of lethargy and statistics the number of participants who developed these symptoms
Number of participants who fell lethargy at certain checkpoint of transplantation
Time frame: 60 days after transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of lethargy and statistics the number of participants who developed these symptoms
Number of participants who fell lethargy at certain checkpoint of transplantation
Time frame: 100 days after transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of lethargy and statistics the number of participants who developed these symptoms
Number of participants who fell lethargy at certain checkpoint of transplantation
Time frame: 180 days after transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of lethargy and statistics the number of participants who developed these symptoms
Number of participants who fell lethargy at certain checkpoint of transplantation
Time frame: 360 days after transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of lethargy and statistics the number of participants who developed these symptoms
Number of participants who fell dizziness, difficulty breathing, biliary colic, headache, stomachache, or anorexia at certain checkpoint of transplantation
Time frame: 5 days before transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of dizziness, difficulty breathing, biliary colic, headache, stomachache, or anorexia and statistics the number of participants who developed these symptoms
Number of participants who fell dizziness, difficulty breathing, biliary colic, headache, stomachache, or anorexia at certain checkpoint of transplantation
Time frame: 6 days after transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of dizziness, difficulty breathing, biliary colic, headache, stomachache, or anorexia and statistics the number of participants who developed these symptoms
Number of participants who fell dizziness, difficulty breathing, biliary colic, headache, stomachache, or anorexia at certain checkpoint of transplantation
Time frame: 30 days after transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of dizziness, difficulty breathing, biliary colic, headache, stomachache, or anorexia and statistics the number of participants who developed these symptoms
Number of participants who fell dizziness, difficulty breathing, biliary colic, headache, stomachache, or anorexia at certain checkpoint of transplantation
Time frame: 60 days after transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of dizziness, difficulty breathing, biliary colic, headache, stomachache, or anorexia and statistics the number of participants who developed these symptoms
Number of participants who fell dizziness, difficulty breathing, biliary colic, headache, stomachache, or anorexia at certain checkpoint of transplantation
Time frame: 100 days after transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of dizziness, difficulty breathing, biliary colic, headache, stomachache, or anorexia and statistics the number of participants who developed these symptoms
Number of participants who fell dizziness, difficulty breathing, biliary colic, headache, stomachache, or anorexia at certain checkpoint of transplantation
Time frame: 180 days after transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of dizziness, difficulty breathing, biliary colic, headache, stomachache, or anorexia and statistics the number of participants who developed these symptoms
Number of participants who fell dizziness, difficulty breathing, biliary colic, headache, stomachache, or anorexia at certain checkpoint of transplantation
Time frame: 360 days after transplantation
Use the Clinical Study Case Reports sheet to record whether each participant developed symptoms of dizziness, difficulty breathing, biliary colic, headache, stomachache, or anorexia and statistics the number of participants who developed these symptoms
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Parenteral nutrition;Enteral nutrition in people with Nutrition Aspect of Cancer and Stem Cell Transplant Complications, run by Hebei Yanda Ludaopei Hospital.
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 5 inclusion and 8 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 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who fell sick and vomit at certain checkpoint of transplantation (time frame: 5 days before transplantation). The study lists 35 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 21 Oct 2022.