TOPLINE:

Compared to a “liberalized” diet, a restrictive neutropenic diet led to significantly fewer major infections — 20.2% vs 31.4% — in patients undergoing hematopoietic stem cell transplantation (HSCT) or induction chemotherapy to treat acute leukemia. Researchers halted the trial early because the major infection rate in the liberalized diet arm exceeded the predefined safety threshold.

METHODOLOGY:

• A neutropenic diet, which requires food to be cooked to high temperatures to avoid food-borne bacteria, is often recommended for neutropenic patients undergoing HSCT or induction therapy for acute leukemia. Although several recent analyses have suggested that infection rates in this patient population may not be worse with liberalized diets, clear evidence supporting a neutropenic over a liberalized diet remains limited.
• To determine the safety of each diet, researchers conducted a single-center phase III noninferiority randomized trial, enrolling 214 evaluable patients undergoing HSCT or induction chemotherapy for acute leukemia, with an expected neutropenia duration of at least 7 days.
• Participants were randomly assigned to either a liberalized diet containing fresh fruits and vegetables or a standard hospital neutropenic diet. Patients were stratified across five subgroups: myeloid acute leukemia, lymphoblastic acute leukemia, and three types of HSCT. Patients had other types of blood cancers, including multiple myeloma and non-Hodgkin lymphoma.
• Researchers assessed whether the rate of major infections in the liberalized diet arm was noninferior to that in the neutropenic diet arm, with a predefined noninferiority margin of < 10% difference in infection rates.
• A major infection was defined as bloodstream infection, infectious pneumonia, invasive fungal disease, Clostridium difficile infection, or typhlitis between the start and end of the intervention. Researchers monitored caloric intake, nutritional status, symptoms, and quality of life using validated assessment tools.

TAKEAWAY:

• Major infections occurred in 31.4% of patients receiving a liberalized diet compared to 20.2% of those on a neutropenic diet, with a difference of 11.2% (P = .58), which exceeded the predefined noninferiority margin. The trial was stopped early because the major infection rate in the liberalized diet arm surpassed the predefined boundary.
• Bloodstream infections were the most common type of infection, occurring in 19% of patients in the liberalized diet arm compared with 10% in the neutropenic diet arm.
• No advantages were observed in symptoms or quality of life between the diet groups. One year survival rates were not significantly different between the two arms: 86.7% in the liberalized diet group and 82.6% in the neutropenic diet group.
• There was no improvement in caloric intake between the two groups — 710 kcal/d in the liberalized diet group compared with 740 kcal/d for neutropenic diet arm (P = .6) — and protein intake remained similar at 31 g/d for both groups (P = .9).

IN PRACTICE:

“These findings suggest that [a liberalized diet] is not a safe alternative to [a neutropenic diet] in HSCT patients and patients with [acute leukemia] because of increased infection risk without nutritional or other benefit,” the study authors concluded.

SOURCE:

The study, led by John R. Wingard, MD, University of Florida College of Medicine, Gainesville, Florida, was published online in the Journal of Clinical Oncology.

LIMITATIONS:

This was a single center study and there may be center-specific practices that could limit the generalizability of the findings. Patients in both diet arms experienced suboptimal calorie and protein intake due to poor appetite, dysgeusia, or mucositis, which may have affected the assessment. Unconfirmed infections could have been a cause of culture-negative neutropenic fever, but this would only be a confounder if occurring at different rates between the two arms.

DISCLOSURES:

The study received support from the University of Florida Health Cancer Center, the Gatorade Trust through a grant by the University of Florida College of Medicine, Department of Medicine, and the Price Eminent Scholar endowment. John R. Wingard, MD, disclosed receiving consulting fees from Celgene, Cidara Therapeutics, F2G, ORCA Therapeutics, Mundipharma, Takeda, and Karius, and having stockownership in NMDP. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.