[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658187":3},{"organization":4,"outcomesModule":7,"designInfo":86,"detailedDescription":94,"studyPopulation":91,"armGroups":95,"interventions":110,"overallOfficials":129,"centralContacts":134,"locations":139,"responsibleParty":185,"collaborators":187,"id":191,"slug":192,"hasResults":193,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":193,"sex":199,"minAge":200,"maxAge":201,"enrollmentInfo":202,"targetDuration":91,"studyType":205,"phases":206,"briefSummary":208,"conditions":209,"keywords":212,"overallStatus":218,"whyStopped":91,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":228},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":21,"otherOutcomes":48},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Incidence of Acute Graft-versus-Host Disease (aGVHD)","Cumulative incidence of acute graft-versus-host disease (skin, gastrointestinal tract, liver) assessed by modified Glucksberg \u002F MAGIC grading criteria.","Within 100 days after transplantation",{"measure":14,"description":15,"timeFrame":16},"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",{"measure":18,"description":19,"timeFrame":20},"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",[22,26,30,34,38,42,45],{"measure":23,"description":24,"timeFrame":25},"Incidence of conditioning-related toxicity","Toxicity graded by NCI-CTCAE 5.0, count cases of grade ≥2 toxicity","From initiation of conditioning to 30 days post-infusion",{"measure":27,"description":28,"timeFrame":29},"Incidence of obstructive sleep apnea(OSA)","Obstructive sleep apnea was detected by non-contact sleep-breath monitoring using millimeter-wave radar.","Day of conditioning, Day 0 (stem-cell infusion day) after hematopoietic stem cell transplantation",{"measure":31,"description":32,"timeFrame":33},"Body weight","Body weight is measured in participants.","Baseline (7 days before conditioning), Conditioning Day, Day 0, Day 14, Day 30, Day 60, Day 90 after hematopoietic stem cell transplantation",{"measure":35,"description":36,"timeFrame":37},"Handgrip strength","Hand dynamometer; dominant hand measured 3 times for average value","Baseline (7 days before conditioning), Day of conditioning, Day 0, Day 14, Day 30, Day 60, Day 90 after hematopoietic stem cell transplantation",{"measure":39,"description":40,"timeFrame":41},"Incidence of adverse events","Incidence of adverse events occurring in participants from the date of signed informed consent throughout oral nutritional supplement intervention period, graded according to CTCAE Version 5.0.","From the date of signed informed consent up to Day 90 after hematopoietic stem cell transplantation",{"measure":43,"description":44,"timeFrame":37},"Patient-Generated Subjective Global Assessment (PG-SGA) score","Complete Patient-Generated Subjective Global Assessment (PG-SGA) questionnaire and calculate total score. The PG-SGA total score ranges from 0 to 35; higher scores indicate greater severity of malnutrition.",{"measure":46,"description":47,"timeFrame":37},"Phase angle","Phase angle is measured by bioelectrical impedance analysis (BIA) in participants.",[49,53,56,60,64,68,72,75,79,82],{"measure":50,"description":51,"timeFrame":52},"Time to neutrophil engraftment","Days from stem-cell infusion to sustained absolute neutrophil count ≥0.5×10\\^9\u002FL for 3 consecutive days.","Up to day +28 after transplantation",{"measure":54,"description":55,"timeFrame":52},"Time to platelet engraftment","Days from stem-cell infusion to sustained platelet count ≥20×10\\^9\u002FL without platelet transfusion support for 7 consecutive days.",{"measure":57,"description":58,"timeFrame":59},"Hospital length of stay","Total days of inpatient hospitalization during transplant treatment for participants.","From admission for transplantation to hospital discharge, assessed up to 1 year after hematopoietic stem cell transplantation",{"measure":61,"description":62,"timeFrame":63},"Medical resource consumption","Consumption of albumin preparations, antimicrobial agents and total hospitalization-related costs.","Up to day +90 after transplantation",{"measure":65,"description":66,"timeFrame":67},"Abnormalities in key laboratory parameters","Abnormal changes of ALT, total bilirubin and serum creatinine.","Baseline up to day +90 after transplantation",{"measure":69,"description":70,"timeFrame":71},"Incidence of nutrition-related severe adverse events","Incidence of pancreatitis, hypersensitivity, grade 4 oral mucositis, refractory vomiting, moderate-to-severe diarrhea.","From study enrollment to day +90 after transplantation",{"measure":73,"description":74,"timeFrame":33},"Anthropometric circumferences","Waist circumference, hip circumference, upper arm circumference and calf circumference are measured in participants.",{"measure":76,"description":77,"timeFrame":78},"Body composition mass parameters assessed by bioelectrical impedance analysis (BIA)","Lean body mass, fat mass, total body water, skeletal muscle mass and bone mineral content are measured by bioelectrical impedance analysis (BIA) in participants.","Baseline (7 days before conditioning), Conditioning Day, Day 0, Day 14, Day 30, Day 60, Day 90 after hematopoietic stem cell transplantation.",{"measure":80,"description":81,"timeFrame":78},"Body composition percentage parameters assessed by bioelectrical impedance analysis (BIA)","Body fat percentage, skeletal muscle percentage and total body water percentage are measured by bioelectrical impedance analysis (BIA) in participants.",{"measure":83,"description":84,"timeFrame":85},"Serious adverse event incidence","Incidence of serious adverse events occurring in participants, defined according to ICH-GCP criteria.","From the date of signed informed consent, assessed up to 3 years after hematopoietic stem cell transplantation",{"allocation":87,"interventionModel":88,"interventionModelDescription":89,"primaryPurpose":90,"observationalModel":91,"timePerspective":91,"maskingInfo":92},"RANDOMIZED","PARALLEL","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.","SUPPORTIVE_CARE",null,{"masking":93,"maskingDescription":91,"whoMasked":91},"NONE","This is a multi-center, open-label, parallel-group randomized controlled study to investigate the effects of peri-transplant oral nutritional supplement (ONS) intervention on clinical disease outcomes among adult patients undergoing myeloablative allogeneic hematopoietic stem-cell transplantation (allo-HSCT).\n\nMalnutrition occurs frequently in allo-HSCT recipients and is associated with higher risks of graft-versus-host disease (GVHD), transplant-related mortality, infection, and poor survival. Malnutrition, intestinal barrier injury and gut microbiota dysbiosis form a vicious cycle that worsens post-transplant complications. In addition, sleep disturbance and obstructive sleep apnea (OSA) are highly prevalent during transplantation and may mediate the relationship between nutritional status and transplant prognosis, which has rarely been objectively evaluated in existing nutrition-related transplant studies. Non-contact millimeter-wave radar-based sleep-breathing monitoring will be applied in this trial to objectively capture sleep-respiratory parameters without wearable devices.\n\nA total of 160 eligible participants will be enrolled in this three-center multicenter study across three Chinese clinical sites (100 participants at the lead center, 30 participants at each of the two collaborative sites), and randomized at a 1:1 ratio within each center into either the intervention group or the control group (80 participants per arm). Randomization will be performed independently within each participating center. All participants will receive routine dietary and physical-activity guidance according to study manuals.\n\nParticipants assigned to the intervention group will receive daily 500 mL Kangquan-Gan enteral nutrition suspension (1 kcal\u002FmL, polymeric whole-protein formula, 500 kcal per bottle, oral nutritional supplement). The initial administration starts at 20-50 mL with 2-3 h during the study observation; if gastrointestinal tolerance is acceptable, the dose will be gradually titrated up to the target 500 mL per day in divided doses (50-100 mL, 4-6 times daily). If gastrointestinal adverse reactions occur, ONS will be paused for 1-3 days and re-challenged. Persistent intolerance will lead to study withdrawal. Remaining energy requirements will be covered by regular oral diet. Parenteral nutrition (PN) will be supplemented when total energy intake continuously falls below 60 % of target energy for 3-5 consecutive days.\n\nParticipants in the control group will receive standard nutritional support with identical dietary guidance, without study-provided ONS. Daily dietary intake will be recorded. Parenteral nutrition will be used to compensate energy shortfalls to meet individual energy and protein targets. To reduce performance bias caused by heightened awareness of nutritional intake among control participants, participants from two study arms will be housed on separate wards whenever feasible.\n\nTarget energy is calculated as the sum of ONS, parenteral nutrition and ordinary dietary intake. Nutritional support teams (physicians, nurses, dietitians, pharmacists) will monitor daily energy intake and adjust nutritional strategies dynamically according to subject tolerance and clinical conditions. During the intervention period, participants are required to avoid other enteral nutritional products, probiotics and prebiotics that may interfere with study outcomes. Unintended consumption will be documented in case report forms.\n\nStudy assessments, physical measurements and biological sample collection will be performed at seven scheduled time-points: baseline (approximately 7 days before conditioning initiation), day 1 of conditioning, stem-cell infusion day, neutrophil engraftment (day +14 post-infusion), post-transplant day 30, day 60 and day 90. Collected biospecimens include stool samples (40 g of the first voided stool of the day at each time-point) for gut microbiota analysis. Fresh stool specimens will be transported to the key laboratory within 2 hours under 4 °C cold-chain conditions, processed and stored long-term at -80 °C for laboratory analyses. Evaluations cover anthropometrics, body-composition analysis, handgrip strength, nutritional assessment (NRS-2002, PG-SGA), laboratory biochemistry, hematology, inflammatory cytokines, immune-cell subsets, bone-marrow examinations, non-contact sleep-apnea monitoring, EORTC-QLQ-C30 quality-of-life questionnaire, 24-hour dietary recall and gastrointestinal symptom rating scale (GSRS).\n\nPrimary outcome measures include overall survival, transplant-related mortality, and cumulative incidence of acute graft-versus-host disease (aGVHD). Secondary outcomes cover incidence of conditioning-related toxicity, adverse-event rates, changes in BMI Z-score, body-fat percentage, skeletal-muscle mass, handgrip strength, and incidence of obstructive sleep apnea. Exploratory endpoints contain neutrophil and platelet engraftment time, albumin transfusion volume, antimicrobial-agent consumption, length of hospital stay and total hospitalization costs. Safety outcomes focus on the incidence of acute pancreatitis, hypersensitivity, grade-4 oral mucositis, refractory vomiting, and moderate-to-severe diarrhea; secondary safety variables include general adverse-event rates and abnormalities of liver- and renal-function laboratory parameters. Adverse events will be graded using CTCAE Version 5.0.\n\nAfter completion of the 90-day intensive observation phase, all participants will undergo long-term follow-up via outpatient visits, telephone and WeChat contact up to 3 years post-transplant at scheduled time-points (6-month, 9-month, 1-year, 1.5-year, 2-year, 2.5-year, 3-year).\n\nPrimary analysis will be performed on the Full-Analysis Set (FAS); safety analysis will be based on the Safety-Set (SS); Per-Protocol-Set (PPS) will be used for sensitivity analysis. Statistical analyses will be performed using SAS 9.4. Cox proportional-hazards regression, logistic regression, repeated-measures analysis of variance, chi-square test, Fisher's exact test, t-test and Wilcoxon rank-sum test will be applied as appropriate. All statistical tests will be two-sided with α = 0.05.\n\nWritten informed consent must be obtained before any study-specific procedures. This trial complies with the Declaration of Helsinki. The study protocol, informed-consent documents and amendments are reviewed and approved by the institutional review board of the lead study site as well as ethics committees of each participating center.",[96,105],{"label":97,"type":98,"description":99,"interventionNames":100},"ONS Nutritional Intervention Group","EXPERIMENTAL","Participants receive 500 mL Kangquangan enteral nutrition suspension (whole-protein formula, 1 kcal\u002FmL, 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.",[101,102,103,104],"Dietary Supplement: Enteral Nutritional Suspension (TP-MCT)","Behavioral: Routine nutritional guidance","Other: Biospecimen-Stool Sample Collection","Other: Non-contact Millimeter-Wave Radar Sleep-Breathing Monitoring",{"label":106,"type":107,"description":108,"interventionNames":109},"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.",[102,103,104],[111,116,121,125],{"type":112,"name":113,"description":114,"armGroupLabels":115,"otherNames":91},"DIETARY_SUPPLEMENT","Enteral Nutritional Suspension (TP-MCT)","500 mL per day of enteral nutritional suspension (TP-MCT), whole-protein formula, 1 kcal\u002FmL, 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.",[97],{"type":117,"name":118,"description":119,"armGroupLabels":120,"otherNames":91},"BEHAVIORAL","Routine nutritional guidance","Standard clinical dietary guidance without oral nutritional supplement. Parenteral nutrition will be supplemented to meet target energy requirements when oral intake is insufficient.",[97,106],{"type":6,"name":122,"description":123,"armGroupLabels":124,"otherNames":91},"Biospecimen-Stool Sample Collection","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.",[97,106],{"type":6,"name":126,"description":127,"armGroupLabels":128,"otherNames":91},"Non-contact Millimeter-Wave Radar Sleep-Breathing Monitoring","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.",[97,106],[130],{"name":131,"affiliation":132,"role":133},"Jingqin Sun, M.Med","Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College","PRINCIPAL_INVESTIGATOR",[135],{"name":131,"role":136,"phone":137,"phoneExt":91,"email":138},"CONTACT","+86-22-23608209","sunjingqin@ihcams.ac.cn",[140,158,170],{"facility":141,"status":91,"city":142,"state":143,"zip":144,"country":145,"countryCode":146,"cosmosGeoPoint":147,"geoPoint":152,"contacts":153},"The First Hospital of Jilin University","Changchun","Jilin","130021","China","CN",{"type":148,"coordinates":149},"Point",[150,151],125.32278,43.88,{"lat":151,"lon":150},[154],{"name":155,"role":136,"phone":156,"phoneExt":91,"email":157},"Yehui Tan, MD, PhD","+86-15948027438","276769165@qq.com",{"facility":132,"status":91,"city":159,"state":160,"zip":161,"country":145,"countryCode":146,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"Tianjin","Tianjin Municipality","301600",{"type":148,"coordinates":163},[164,165],117.17667,39.14222,{"lat":165,"lon":164},[168,169],{"name":131,"role":136,"phone":137,"phoneExt":91,"email":138},{"name":131,"role":133,"phone":91,"phoneExt":91,"email":91},{"facility":171,"status":91,"city":172,"state":173,"zip":174,"country":145,"countryCode":146,"cosmosGeoPoint":175,"geoPoint":179,"contacts":180},"The First Affiliated Hospital of Wenzhou Medical University","Wenzhou","Zhejiang","325000",{"type":148,"coordinates":176},[177,178],120.66682,27.99942,{"lat":178,"lon":177},[181],{"name":182,"role":136,"phone":183,"phoneExt":91,"email":184},"Hanping Shi, MD, PhD","+86-13802741263","shihp@vip.163.com",{"type":186,"investigatorFullName":91,"investigatorTitle":91,"investigatorAffiliation":91,"oldNameTitle":91,"oldOrganization":91},"SPONSOR",[188],{"name":189,"class":190},"Nutricia Pharmaceutical Co., Ltd.","UNKNOWN","100658187","nutritional-intervention-for-patients-undergoing-allogeneic-hematopoietic-stem-cell-transplantation-100658187",false,"NCT07850375","Nutritional Intervention for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation","Effect of Nutritional Intervention on Disease Outcomes in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation","HSCT-NUT","Inclusion Criteria:\n\n1. 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;\n2. Expected survival ≥ 3 months;\n3. Age between 18 and 65 years (inclusive), with no restrictions on sex or race;\n4. ECOG performance status ≤ 2;\n5. NRS2002 score ≥ 3;\n6. The patient, or his\u002Fher authorized legal representative, agrees to participate in the clinical trial and signs the informed consent form.\n\nExclusion Criteria:\n\n1. Relapsed and refractory acute myeloid leukemia;\n2. Acute myeloid leukemia, myelodysplastic syndrome and acute lymphoblastic leukemia with positive MRD prior to transplantation;\n3. Patients with concomitant other malignant tumors requiring treatment;\n4. Presence of active infections, such as hepatitis B, hepatitis C, tuberculosis, etc.;\n5. Patients with positive HIV serology;\n6. 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;\n7. 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;\n8. Regular use of enteral nutrition preparations within 1 month prior to study entry;\n9. Suspected allergy to the investigational product or any of its excipients; Patients deemed unsuitable for participation by the investigator.","ALL","18 Years","65 Years",{"count":203,"type":204},160,"ESTIMATED","INTERVENTIONAL",[207],"NA","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.",[210,211],"Hematopoietic Stem Cell Transplantation (HSCT)","Malnutrition (Calorie)",[213,214,215,216,217],"llogeneic hematopoietic stem cell transplantation","Oral nutritional supplement","Enteral nutrition","Malnutrition","Graft-versus-host disease","NOT_YET_RECRUITING","2026-09-24",{"date":221,"type":222},"2026-09-30","ACTUAL",{"date":224,"type":204},"2026-10-12",{"date":226,"type":204},"2030-10-30",{"name":5,"class":6},3]