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

Abstract

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.

Nutritional aspects in autoimmune diseases undergoing hematopoietic stem cell transplantation: overview and recommendations on behalf of the EBMT ADWP and Nurses Group

“…Regarding nutritional support with LBD or non-restrictive diet (NRD), the literature points out that the former has shown no benefit on infection rates or survival, in contrast with the routine use of low-microbial foods in clinical practice ( 39 ). Moreover, results from a recent randomized study by Stella et al ( 33 ) demonstrated that the frequency of infections, deaths, nutritional outcomes, and acute GvHD was not different in patients receiving LBD versus NRD during the neutropenic phase after HSCT. These results suggest that the use of a restrictive diet is an unnecessary burden for patients’ QoL, even if, undoubtedly, data are more mature in the autologous HSCT setting in which LBD should no longer be recommended.…”

“…Despite advances in supportive care, infections remain a significant cause of morbidity and mortality in the setting of HSCT ( 33 , 34 ). The resultant injury on the gastrointestinal epithelial barrier by chemotherapy (CT) or radiotherapy (RT), and the extensive use of antibiotics during the neutropenic phase, may lead to gut microbiota dysbiosis ( 35 ).…”

“…Various measures have been adopted to minimize the incidence of infections, including the use of a low-bacterial diet (LBD) that excludes raw food, fresh fruits, and vegetables ( 33 ). The rationale behind the use of LBD is to prevent the introduction of dangerous bacteria into the gastrointestinal tract, already damaged by CT or RT ( 33 , 38 ).…”

“…Various measures have been adopted to minimize the incidence of infections, including the use of a low-bacterial diet (LBD) that excludes raw food, fresh fruits, and vegetables ( 33 ). The rationale behind the use of LBD is to prevent the introduction of dangerous bacteria into the gastrointestinal tract, already damaged by CT or RT ( 33 , 38 ). Regarding nutritional support with LBD or non-restrictive diet (NRD), the literature points out that the former has shown no benefit on infection rates or survival, in contrast with the routine use of low-microbial foods in clinical practice ( 39 ).…”

The sweet taste of liberalizing dietary restrictions in HCT

“…In this issue of Blood Advances , Stella et al report their findings from a multicenter trial that randomly assigned patients undergoing hematopoietic stem cell transplantation (HCT) to a traditional restrictive neutropenic diet or a liberalized diet. 1 More than 200 patients who underwent auto- and allo-HCT and underwent treatment at 3 transplant centers in Italy were included in the study, and the authors found that restricting posttransplant dietary options conferred no benefit with regard to the incidence of severe infections or any of the secondary outcomes studied. The key differences between the restrictive and liberalized diet recommendations are summarized in the figure.…”