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Not Yet Recruiting NCT07850375

Nutritional Intervention for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Conditions: Hematopoietic Stem Cell Transplantation (HSCT), Malnutrition (Calorie)

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 160
Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Location: The First Hospital of Jilin University Changchun Jilin

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.

Eligibility Criteria

Inclusion Criteria: 1. 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; 2. Expected survival ≥ 3 months; 3. Age between 18 and 65 years (inclusive), with no restrictions on sex or race; 4. ECOG performance status ≤ 2; 5. NRS2002 score ≥ 3; 6. The patient, or his/her authorized legal representative, agrees to participate in the clinical trial and signs the informed consent form. Exclusion Criteria: 1. Relapsed and refractory acute myeloid leukemia; 2. Acute myeloid leukemia, myelodysplastic syndrome and acute lymphoblastic leukemia with positive MRD prior to transplantation; 3. Patients with concomitant other malignant tumors requiring treatment; 4. Presence of active infections, such as hepatitis B, hepatitis C, tuberculosis, etc.; 5. Patients with positive HIV serology; 6. 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; 7. 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; 8. Regular use of enteral nutrition preparations within 1 month prior to study entry; 9. Suspected allergy to the investigational product or any of its excipients; Patients deemed unsuitable for participation by the investigator.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07850375). StuddyBuddy aggregates publicly available trial information.