UnknownNot Applicable

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

106 participantsStarted 2022-11-01

Plain-language 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.

Who can participate

Age range12 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

What they're measuring

Number of participants who fell sick and vomit at certain checkpoint of transplantation

Timeframe: 5 days before transplantation

Number of participants who fell sick and vomit at certain checkpoint of transplantation

Timeframe: 6 days after transplantation

Number of participants who fell sick and vomit at certain checkpoint of transplantation

Timeframe: 30 days after transplantation

Number of participants who fell sick and vomit at certain checkpoint of transplantation

Timeframe: 60 days after transplantation

Number of participants who fell sick and vomit at certain checkpoint of transplantation

Timeframe: 100 days after transplantation

Number of participants who fell sick and vomit at certain checkpoint of transplantation

Timeframe: 180 days after transplantation

Number of participants who fell sick and vomit at certain checkpoint of transplantation

Timeframe: 360 days after transplantation

Trial details

NCT IDNCT05590091

SponsorHebei Yanda Ludaopei Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-31

View on ClinicalTrials.gov More Nutrition Aspect of Cancer trials

Plain-language summary

Who can participate

Age range12 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of participants who fell sick and vomit at certain checkpoint of transplantation

Timeframe: 5 days before transplantation

Number of participants who fell sick and vomit at certain checkpoint of transplantation

Timeframe: 6 days after transplantation

Number of participants who fell sick and vomit at certain checkpoint of transplantation

Timeframe: 30 days after transplantation

Number of participants who fell sick and vomit at certain checkpoint of transplantation

Timeframe: 60 days after transplantation

Number of participants who fell sick and vomit at certain checkpoint of transplantation

Timeframe: 100 days after transplantation

Number of participants who fell sick and vomit at certain checkpoint of transplantation

Timeframe: 180 days after transplantation

Number of participants who fell sick and vomit at certain checkpoint of transplantation

Timeframe: 360 days after transplantation