Nonrestrictive diet does not increase infections during post-HSCT neutropenia: data from a multicenter randomized trial.
Autor: | Stella F; Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy., Marasco V; Division of Hematology and Bone Marrow Transplant, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei Tumori, Milan, Italy., Levati GV; Division of Hematology and Bone Marrow Transplant, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei Tumori, Milan, Italy., Guidetti A; Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy.; Division of Hematology and Bone Marrow Transplant, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei Tumori, Milan, Italy., De Filippo A; Division of Hematology and Bone Marrow Transplant, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei Tumori, Milan, Italy., Pennisi M; Division of Hematology and Bone Marrow Transplant, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei Tumori, Milan, Italy., Vismara C; Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy., Miceli R; Biostatistics for Clinical Research Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei Tumori, Milan, Italy., Ljevar S; Biostatistics for Clinical Research Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei Tumori, Milan, Italy., Tecchio C; Department of Medicine, Section of Hematology and Bone Marrow Transplant Unit, University of Verona, Verona, Italy., Mordini N; Division of hematology, Azienda Ospedaliera S. Croce e Carle, Cuneo, Italy., Gobbi G; Division of Hematology and Bone Marrow Transplant, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei Tumori, Milan, Italy., Saracino L; Division of Hematology and Bone Marrow Transplant, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei Tumori, Milan, Italy., Corradini P; Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy.; Division of Hematology and Bone Marrow Transplant, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei Tumori, Milan, Italy. |
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Jazyk: | angličtina |
Zdroj: | Blood advances [Blood Adv] 2023 Oct 10; Vol. 7 (19), pp. 5996-6004. |
DOI: | 10.1182/bloodadvances.2023010348 |
Abstrakt: | Infections are a major cause of morbidity and mortality during neutropenia after hematopoietic stem cell transplantation (HSCT). The use of a low-microbial protective diet (PD) in the peritransplantation period is a standard of care, although its efficacy has never been tested prospectively. We conducted a multicenter, randomized, noninferiority trial, enrolling all consecutive adult patients undergoing high-dose induction chemotherapy or HSCT with the objective to compare nonrestrictive diet (NRD) vs PD. Overall, 222 patients were enrolled, randomly assigned, and analyzed. One hundred seventy-five subjects (79%) received autologous HSCT (auto-HSCT), 41 (18%) received allogeneic HSCT (allo-HSCT), and 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 2 arms. In multivariable analysis, only multiple myeloma diagnosis, fluoroquinolone prophylaxis, and the absence of mucositis were associated with a 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 2 arms. In allo-HSCT recipients, the incidence of acute graft-versus-host disease grade ≥3 was similar. NRD was associated with higher patient-reported satisfaction. In conclusion, NRD is not inferior to a traditional PD during neutropenia after HSCT, and our results demonstrated that implementing a restrictive diet unnecessary burdens patients' quality of life. The clinical trial was registered prospectively in the clinical trial registry of the Istituto Nazionale dei Tumori of Milan as INT54/16. (© 2023 by The American Society of Hematology. Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0), permitting only noncommercial, nonderivative use with attribution. All other rights reserved.) |
Databáze: | MEDLINE |
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