Randomized noninferiority trial of a liberalized diet versus neutropenic diet in hematopoietic stem-cell transplant patients and patients with acute leukemia

Patients undergoing hematopoietic stem-cell transplantation (HSCT) or induction chemotherapy for acute leukemia (AL) generally receive a low-bacterial neutropenic diet (ND) to minimize infection from ingested microbes. A phase 3 randomized trial at the University of Florida College of Medicine (Gainesville) investigated whether the rate of major infections in patients receiving a more liberalized diet (LD) was noninferior to than in ND patients and whether an LD improved caloric intake and nutritional status. Patients were randomized to either an ND or LD, containing fresh fruits and vegetables. The primary endpoint was the development of any major infection during neutropenia. The trial was halted at the second interim analysis after enrolling 214 evaluable patients, because the LD arm’s major infection rate surpassed the predefined stopping boundary of ≤ 10%. In the LD arm, major infections occurred in 31.4% of patients compared with 20.2% of patients in the ND arm. Furthermore, the caloric intake in the LD arm was not improved, and nearly two thirds of patients on both diets reported critical nutritional problems. There was no advantage in symptoms, quality of life, or survival in the LD arm. The authors conclude that these findings suggest that LD is not a safe alternative to ND in HSCT patients and patients with AL.