Nonrestrictive diet does not increase infections during post-HSCT neutropenia: data from a multicenter randomized trial.

Infections are a major cause of morbidity and mortality during neutropenia after chemo-radio therapy and hematopoietic stem cell transplantation (HSCT). The use of low-microbial Protective-Diet (PD) in the peri-transplant period is a standard of care despite its efficacy has never been tested prospectively. We conducted a multicenter, randomized, non-inferiority trial enrolling all consecutive adult patients undergoing high-dose-induction chemotherapy or HSCT with the objective to compare Non-Restrictive-Diet (NRD) versus PD. Overall, 222 patients were enrolled, randomized, and analyzed. One hundred and seventy-five (79%) subjects received autologous-HSCT, 41(18%) received allogeneic-HSCT while 6(3%) patients received high-dose-induction chemotherapy. There was no significant difference in terms of incidence of Grade≥2 infections and death during neutropenia in the two arms (65% in PD vs 61% in NRD patients,RR=1.0;95%CI=0.9-1.3,p=0.7). In multivariable analysis, only multiple myeloma diagnosis, fluoroquinolone prophylaxis and absence of mucositis were associated with lower incidence of Grade≥2 infections. We did not report any significant variation in terms of hospitalization length, incidence of mucositis and gastrointestinal infections, body weight and serum albumin variations in the two arms. In allogeneic-HSCT recipients, the incidence of acute Graft Versus Host Disease (aGVHD) grade≥3 was similar (20% in PD vs 9.5% in NRD, p=0.4;RR=2.1,95%CI=0.5-9.1,p=0.4). NRD was associated with higher patients' satisfaction (16% in PD vs 35% in NRD, RR=0.5;95%CI= 0.3-0.8;p=0.003). In conclusion Non-Restrictive diet is non-inferior to traditional Protective diet during neutropenia after HSCT, our results demonstrated that implementing a restrictive diet unnecessary burdens patients' quality of life.