NCT07850375

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
49mo left

Started Oct 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 30, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

October 12, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2027

3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2030

Last Updated

September 30, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 15, 2026

Last Update Submit

September 24, 2026

Conditions

Hematopoietic Stem Cell Transplantation (HSCT)Malnutrition (Calorie)

Keywords

llogeneic hematopoietic stem cell transplantationOral nutritional supplementEnteral nutritionMalnutritionGraft-versus-host disease

Outcome Measures

Primary Outcomes (3)

  • 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.

    Within 100 days after transplantation

  • 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 years after allogeneic hematopoietic stem-cell transplantation

  • 3-year Transplant-Related Mortality

    Cumulative incidence of transplant-related mortality within 3 years after hematopoietic stem cell transplantation.

    From Day 0 after hematopoietic stem cell transplantation until the date of transplant-related death, assessed up to 3 years

Secondary Outcomes (7)

  • Incidence of conditioning-related toxicity

    From initiation of conditioning to 30 days post-infusion

  • Incidence of obstructive sleep apnea(OSA)

    Day of conditioning, Day 0 (stem-cell infusion day) after hematopoietic stem cell transplantation

  • Body weight

    Baseline (7 days before conditioning), Conditioning Day, Day 0, Day 14, Day 30, Day 60, Day 90 after hematopoietic stem cell transplantation

  • Handgrip strength

    Baseline (7 days before conditioning), Day of conditioning, Day 0, Day 14, Day 30, Day 60, Day 90 after hematopoietic stem cell transplantation

  • Incidence of adverse events

    From the date of signed informed consent up to Day 90 after hematopoietic stem cell transplantation

  • +2 more secondary outcomes

Other Outcomes (10)

  • Time to neutrophil engraftment

    Up to day +28 after transplantation

  • Time to platelet engraftment

    Up to day +28 after transplantation

  • Hospital length of stay

    From admission for transplantation to hospital discharge, assessed up to 1 year after hematopoietic stem cell transplantation

  • +7 more other outcomes

Study Arms (2)

ONS Nutritional Intervention Group

EXPERIMENTAL

Participants receive 500 mL Kangquangan enteral nutrition suspension (whole-protein formula, 1 kcal/mL, Nutricia Pharmaceutical (Wuxi) Co., Ltd.) daily, combined with routine dietary guidance. Additional parenteral nutrition will be supplemented if daily energy intake continuously fails to reach 60% of target energy for 3-5 consecutive days. Dose titration: initial 20-50 mL, gradually escalated to target dose according to gastrointestinal tolerance.

Dietary Supplement: Enteral Nutritional Suspension (TP-MCT)Behavioral: Routine nutritional guidanceOther: Biospecimen-Stool Sample CollectionOther: Non-contact Millimeter-Wave Radar Sleep-Breathing Monitoring

Routine Nutritional Support Group

ACTIVE COMPARATOR

Participants receive routine dietary guidance without oral nutritional supplement. Parenteral nutrition will be supplemented to meet target energy requirements when oral intake is insufficient.

Behavioral: Routine nutritional guidanceOther: Biospecimen-Stool Sample CollectionOther: Non-contact Millimeter-Wave Radar Sleep-Breathing Monitoring

Interventions

Enteral Nutritional Suspension (TP-MCT)DIETARY_SUPPLEMENT

500 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.

ONS Nutritional Intervention Group
Routine nutritional guidanceBEHAVIORAL

Standard clinical dietary guidance without oral nutritional supplement. Parenteral nutrition will be supplemented to meet target energy requirements when oral intake is insufficient.

ONS Nutritional Intervention GroupRoutine Nutritional Support Group
Biospecimen-Stool Sample CollectionOTHER

Collection 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.

ONS Nutritional Intervention GroupRoutine Nutritional Support Group
Non-contact Millimeter-Wave Radar Sleep-Breathing MonitoringOTHER

24-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.

ONS Nutritional Intervention GroupRoutine Nutritional Support Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • NRS2002 score ≥ 3;
  • The patient, or his/her authorized legal representative, agrees to participate in the clinical trial and signs the informed consent form.

You may not qualify if:

  • 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.;
  • Patients with positive HIV serology;
  • Patients with impairment of one or more major organs including heart, lung, liver and kidney, severe abnormal glucose metabolism, or those assessed by the investigator as unable to tolerate treatment;
  • Patients with clinical symptoms of cerebral dysfunction, severe psychiatric disorders, or other conditions rendering them unable to understand or comply with treatment and monitoring requirements;
  • Regular use of enteral nutrition preparations within 1 month prior to study entry;
  • Suspected allergy to the investigational product or any of its excipients; Patients deemed unsuitable for participation by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Tianjin, Tianjin Municipality, 301600, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

MeSH Terms

Conditions

MalnutritionGraft vs Host Disease

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesImmune System Diseases

Study Officials

  • Jingqin Sun, M.Med

    Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingqin Sun, M.Med

CONTACT

+86-22-23608209sunjingqin@ihcams.ac.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This is a parallel-group randomized trial with two arms. Subjects are allocated at a 1:1 ratio to the oral nutritional supplement intervention group or the routine nutritional support control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2026

First Posted

September 30, 2026

Study Start (Estimated)

October 12, 2026

Primary Completion (Estimated)

October 30, 2027

Study Completion (Estimated)

October 30, 2030

Last Updated

September 30, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared with other external researchers. Analyzed aggregate study results may be published in peer-reviewed journals.

Locations

CN(3)