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| ID | Type | Description | Link |
|---|---|---|---|
| UF-BMT-LDND-101 | Other Identifier | University of Florida | |
| OCR15632 | Other Identifier | UF OnCore | |
| UF-HEM-007 | Other Identifier | University of Florida |
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Interim analysis determined that study reached a safety stopping rule
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This is an open-label, two-arm, phase III non-inferiority trial to evaluate the safety of a liberalized hospital diet inclusive of fresh fruits and vegetables to a neutropenic diet in patients with prolonged neutropenia. Both cohorts and diets will adhere to the hygiene and common sense advice listed in the FDA-endorsed food safety guidelines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liberalized Hospital Diet (Diet A) | Active Comparator | Diet A would include fresh fruits and/or fresh vegetables in a liberalized hospital diet, and subjects will be encouraged to eat at least one daily serving of fresh fruits and/or vegetables. |
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| Neutropenic Diet (Diet B) | Active Comparator | Diet B is the hospital neutropenic diet. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet | Other | Diet Intervention: Subjects will undergo stratified randomization to account for the heterogeneous population, to receive one of the two diets: liberalized hospital diet (Diet A) or a neutropenic diet (Diet B). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of major infections | The primary objective of the trial is to compare the incidence of major infections in subjects undergoing HSCT or receiving induction chemotherapy for acute leukemia with prolonged neutropenia (less than or equal to 7 days) who are receiving either Diet A or Diet B. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of infections in each diet group | This secondary objective of the trial is to compare the impact of diet on severe infections including: septic shock, bloodstream infection, invasive fungal infection, upper respiratory infection, infectious & non-infectious pneumonia, C. difficile infection, Vancomycin-resistant & -sensitive enterococcal colonization, Vancomycin-resistant & -sensitive enterococcal infections, febrile neutropenia, typhlitis, lower tract respiratory viral infections, infection-related mortality, and admission to the ICU. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Crispen, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF Health Cancer Center | Gainesville | Florida | 32608 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41406403 | Derived | Wingard JR, Lee JH, Li D, Al-Mansour Z, Farhadfar N, Hsu J, Hiemenz J, Dean EA, Brown R, Trikha G, Schulz JN, Cline CL, Leather H, Sugrue MW, Dahl WJ, McGee KH, Leggett A, Kelly DL. Randomized Noninferiority Trial of a Liberalized Diet Versus the Neutropenic Diet in Hematopoietic Stem-Cell Transplant Patients and Patients With Acute Leukemia. J Clin Oncol. 2026 Feb;44(4):300-310. doi: 10.1200/JCO-25-00889. Epub 2025 Dec 17. |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D009190 | Myelodysplastic Syndromes |
| D007239 | Infections |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| 1 year |
| Admission frequency | This secondary objective of the trial will examine the admission frequency to the intensive care unit (ICU). | 1 year |
| Compliance | This secondary objective of the trial will evaluate the degree of compliance to each diet from the time of initiation of the diet intervention until either the Absolute Neutrophil Count (ANC) is equal to or less than 500/mm3, the subject is discharged from the hospital, the subject is transferred from the unit, or after 30 days of ANC less than 500/mm3. | 1 year |
| Patient-Generated Subjective Global Assessment (PG-SGA) | This secondary objective of the trial will evaluate the impact of each diet on nutritional status as assessed by PG-SGA. | 1 year |
| Incidence of mucositis | This secondary objective of the trial will evaluate the impact of mucositis on dietary intake. | 1 year |
| Symptom incidence | This secondary objective of the trial is to compare symptoms between diets using the MDASI tool. | 1 year |
| Quality of life (QoL) | This secondary objective of the trial is to compare the QoL between diets as assessed by FACT-G. | 1 year |
| Overall survival (OS) | This secondary objective of the trial is to evaluate OS from 1 year following randomization | 1 year |
| Progression free survival (PFS) | This secondary objective of the trial is to evaluate PFS from 1 year following randomization | 1 year |
| Incidence of graft vs.host disease (GVHD) | This secondary objective of the trial is to evaluate the incidence of GVHD in allogeneic HSCT subjects only. | 1 year |
| D001855 | Bone Marrow Diseases |