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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
217
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).
UF Health Cancer Center
Gainesville, Florida, United States
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.
Time frame: 1 year
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.
Time frame: 1 year
Admission frequency
This secondary objective of the trial will examine the admission frequency to the intensive care unit (ICU).
Time frame: 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.
Time frame: 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.
Time frame: 1 year
Incidence of mucositis
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This secondary objective of the trial will evaluate the impact of mucositis on dietary intake.
Time frame: 1 year
Symptom incidence
This secondary objective of the trial is to compare symptoms between diets using the MDASI tool.
Time frame: 1 year
Quality of life (QoL)
This secondary objective of the trial is to compare the QoL between diets as assessed by FACT-G.
Time frame: 1 year
Overall survival (OS)
This secondary objective of the trial is to evaluate OS from 1 year following randomization
Time frame: 1 year
Progression free survival (PFS)
This secondary objective of the trial is to evaluate PFS from 1 year following randomization
Time frame: 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.
Time frame: 1 year