Findings of a new study suggest that maintaining a traditional neutropenic (cooked-food–only) diet during hospitalization for blood cancer treatment may be beneficial. Patients assigned to a liberalized diet experienced a higher incidence of major infections, and greater adherence to the liberalized diet was associated with an even higher infection risk. These results support the long-standing practice of dietary restrictions to help reduce infection risk in this vulnerable population. The study was published in the Journal of Clinical Oncology by John R. W. and colleagues.
Neutropenic diets have long been recommended as a means of preventing infection in the presence of profound immunosuppression, although recent smaller-scale studies questioned their necessity and found the liberalized neutropenic diet to be safe and improve nutritional intake. This trial sought to establish whether a neutropenic diet that is liberalized is noninferior concerning major infection rates in the presence of neutropenia and whether it improves caloric or nutritional intake, quality of life, or survival.
The study was a Phase III randomized trial that was performed on patients receiving HSCT or induction chemotherapy for acute leukemia. The patients were randomly allotted to either a conventional neutropenic diet or a liberalized one that could include raw fruits and vegetables. The primary outcome was the development of any major infection during neutropenia. Noninferiority was assumed if the difference in the major infection rate was not more than 10%.
A total of 214 evaluable patients were enrolled before the study was stopped at the second interim analysis. Early trial termination occurred because the major infection rate in the liberalized diet arm crossed the prespecified safety boundary. Patients in both groups were comparable with respect to treatment intensity and baseline risk for infection and malnutrition.
Key findings
The incidence rate of major infection was 31.4% with the liberalized diet and 20.2% with the neutropenic diet.
The absolute difference was 11.2%, surpassing the margin for noninferiority, with values ranging from -0.4% to 22.9% (P = 0.58).
Calorie intake did not improve with the liberalized diet despite increased food availability.
Approximately two-thirds of both groups found their nutritional concerns to be critical.
This phase III trial shows that a liberalized diet is not a safe alternative to a neutropenic diet for patients undergoing HSCT or induction chemotherapy for acute leukemia because it increases the risk of infection rather than enhancing nutrition and other patient-centered outcomes. Future studies should aim at identifying other dietary approaches that can optimize nutrition without risking infection in immunocompromised hosts.
Reference:
Wingard, J. R., Lee, J.-H., Li, D., Al-Mansour, Z., Farhadfar, N., Hsu, J., Hiemenz, J., Dean, E. A., Brown, R., Trikha, G., Schulz, J. N., Cline, C. L., Leather, H., Sugrue, M. W., Dahl, W. J., McGee, K. H., Leggett, A., & Kelly, D. L. (2025). Randomized noninferiority trial of a liberalized diet versus the neutropenic diet in hematopoietic stem-cell transplant patients and patients with acute leukemia. Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology, JCO-25-00889, JCO2500889. https://doi.org/10.1200/JCO-25-00889
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