This is a multi-center observational study. The study aims to explore the effect of enteral nutritional support on nutritional status and clinical outcomes in patients after hematopoietic stem cell transplantation. Eligible participants will receive routine clinical care combined with nutritional intervention at each participating site. We will collect clinical and laboratory indicators to evaluate changes in nutrition-related indexes. No extra invasive procedures will be performed for research purposes.
Patients with primary hematological diseases of acute lymphoblastic leukemia, acute myeloid leukemia, or myelodysplastic syndrome who have an indication for allogeneic hematopoietic stem cell transplantation (Allo-HSCT) and are scheduled to undergo myeloablative conditioning;
Expected survival ≥ 3 months;
Age between 18 and 65 years (inclusive), with no restrictions on sex or race;
ECOG performance status ≤ 2;
Relapsed and refractory acute myeloid leukemia;
Acute myeloid leukemia, myelodysplastic syndrome and acute lymphoblastic leukemia with positive MRD prior to transplantation;
Patients with concomitant other malignant tumors requiring treatment;
Presence of active infections, such as hepatitis B, hepatitis C, tuberculosis, etc.;
Parallel
Enteral Nutritional Suspension (TP-MCT)
Dietary supplement500 mL per day of enteral nutritional suspension (TP-MCT), whole-protein formula, 1 kcal/mL, administered orally in addition to routine dietary guidance. Dose titrated from 20-50 mL initial volume to target dose according to gastrointestinal tolerance. Provided by Nutricia Pharmaceutical (Wuxi) Co., Ltd.
Routine nutritional guidance
BehavioralStandard clinical dietary guidance without oral nutritional supplement. Parenteral nutrition will be supplemented to meet target energy requirements when oral intake is insufficient.
Biospecimen-Stool Sample Collection
Other interventionCollection of 40 g first-voided fresh stool samples at seven predefined study time-points for gut microbiota analysis. Specimens are transported under 4 °C cold-chain conditions and stored long-term at -80 °C for laboratory testing.
Non-contact Millimeter-Wave Radar Sleep-Breathing Monitoring
Other intervention24-hour non-contact sleep-breathing monitoring is performed via millimeter-wave radar device on the day of conditioning initiation and on the day of stem-cell infusion. No wearable sensors are required for participants to collect sleep-respiratory parameters.
Incidence of Acute Graft-versus-Host Disease (aGVHD)
Cumulative incidence of acute graft-versus-host disease (skin, gastrointestinal tract, liver) assessed by modified Glucksberg / MAGIC grading criteria.
3-year Overall Survival Rate
Overall survival rate, defined as the proportion of participants alive at 3-year follow-up after allogeneic hematopoietic stem-cell transplantation; death from any cause is treated as event.
3-year Transplant-Related Mortality
Cumulative incidence of transplant-related mortality within 3 years after hematopoietic stem cell transplantation.
Incidence of conditioning-related toxicity
Toxicity graded by NCI-CTCAE 5.0, count cases of grade ≥2 toxicity
Incidence of obstructive sleep apnea(OSA)
Obstructive sleep apnea was detected by non-contact sleep-breath monitoring using millimeter-wave radar.
Body weight
Body weight is measured in participants.
Handgrip strength
Hand dynamometer; dominant hand measured 3 times for average value
Time to neutrophil engraftment
Days from stem-cell infusion to sustained absolute neutrophil count ≥0.5×10\^9/L for 3 consecutive days.
Time to platelet engraftment
Days from stem-cell infusion to sustained platelet count ≥20×10\^9/L without platelet transfusion support for 7 consecutive days.
Hospital length of stay
Total days of inpatient hospitalization during transplant treatment for participants.
Medical resource consumption
Consumption of albumin preparations, antimicrobial agents and total hospitalization-related costs.
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Institute of Hematology & Blood Diseases Hospital, China
Lead sponsor
Nutricia Pharmaceutical Co., Ltd.
Collaborator
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