Study on Intelligent Nutrition Support Therapy for Hematopoietic Stem Cell Transplantation Recipients

NCT05590091 | Unknown

• 1 other identifier: DPJG-Y-202205
• Study Type: interventional
• Target: 106
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Nutrition Aspect of Cancer; Stem Cell Transplant Complications

Keywords

HSCT; Nutrition therapy; Intestinal graft-versus-host disease

Outcome Measures

Primary Outcomes (35)

• 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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  360 days after transplantation

Study Arms (2)

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

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.

Interventions

Parenteral nutrition;Enteral nutrition OTHER

The intelligent nutrition management system was used to carry out standardized nutrition management of patients after hematopoietic stem cell transplantation

Experimental group

Eligibility Criteria

• Age: 12 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hebei Yanda Ludaopei Hospital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: October 21, 2022
• Study Start: November 1, 2022
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: October 21, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share