Comparing Two Diets in Patients Undergoing HSCT or Remission Induction Chemo for Acute Leukemia and MDS (UF-BMT-LDND-101)

Study Overview
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Brief Summary
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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.

Official Title
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A Phase III, Randomized, Clinical Trial Comparing Two Diets in Patients Undergoing Hematopoietic Stem Cell Transplant (HSCT) or Remission Induction Chemotherapy for Acute Leukemia and Myelodysplastic Syndrome (UF-BMT-LDND-101)

Conditions
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Leukemia, Myelodysplastic Syndromes

Intervention / Treatment
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* Other: Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Undergoing treatment for hematologic malignancies or HSCT as outlined below: Underlying diagnosis for non-HSCT patients: Acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) receiving induction or reinduction chemotherapy; OR Acute lymphoblastic leukemia (ALL) receiving an intensive induction chemotherapy (e.g., HyperCVAD±R, CALGB9251, Larsons protocol) with an expected duration of neutropenia of ≥7 days; OR Allogeneic or autologous HSCT for any indication. For patients undergoing reduced intensity conditioning, only those regimens in which the expected neutropenia is ≥ 7 days are permitted and the patient must reside in the hospital Expected duration of neutropenia of ≥ 7 days Exclusion Criteria: Use of anti infectives for treatment of active systemic infections within 7 days prior to initiation of study diet Untreated major infection at presentation Patients with uncontrolled invasive fungal infection (defined as those who have not completed at least 6 weeks of treatment; or who are symptomatic with two CT scans, at least 1 week apart showing uncontrolled disease at the time of initiation of study diet) Uncontrolled HIV, Hepatitis B and C infection Receipt of nutrition via enteral tube or total parenteral nutrition at the time of enrollment Patients unwilling to eat fresh fruit and/or vegetables Planned management of neutropenia in the outpatient setting

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Liberalized Hospital Diet (Diet A)<br>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. | Other: Diet<br>* 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).<br>|
| Active Comparator: Neutropenic Diet (Diet B)<br>Diet B is the hospital neutropenic diet. | Other: Diet<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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leukemia, myelodysplastic, myeloid, lymphoblastic, diet, infection, hematopoietic, stem cell, transplant