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Malnutrition Prevention after Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT): A Prospective Explorative Interventional Study with an Oral Polymeric Formulation Enriched with Transforming Growth Factor Beta 2 (TGF-β2)

Malnutrition is common after allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT), and interventions directed to correct nutritional status are warranted to improve transplant outcomes. In this prospective study, an oral polymeric formulation enriched with TGF-β2 (TE-OPF) was explored to co...

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Autores principales: Morello, Enrico, Arena, Francesco, Malagola, Michele, Farina, Mirko, Polverelli, Nicola, Cavagna, Elsa, Colnaghi, Federica, Donna, Lorenzo, Zollner, Tatiana, Accorsi Buttini, Eugenia, Andreoli, Marco, Ricci, Chiara, Leoni, Alessandro, Samarani, Emanuela, Bertulli, Alice, Leali, Daria, Bernardi, Simona, Russo, Domenico
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9460256/
https://www.ncbi.nlm.nih.gov/pubmed/36079847
http://dx.doi.org/10.3390/nu14173589
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author Morello, Enrico
Arena, Francesco
Malagola, Michele
Farina, Mirko
Polverelli, Nicola
Cavagna, Elsa
Colnaghi, Federica
Donna, Lorenzo
Zollner, Tatiana
Accorsi Buttini, Eugenia
Andreoli, Marco
Ricci, Chiara
Leoni, Alessandro
Samarani, Emanuela
Bertulli, Alice
Leali, Daria
Bernardi, Simona
Russo, Domenico
author_facet Morello, Enrico
Arena, Francesco
Malagola, Michele
Farina, Mirko
Polverelli, Nicola
Cavagna, Elsa
Colnaghi, Federica
Donna, Lorenzo
Zollner, Tatiana
Accorsi Buttini, Eugenia
Andreoli, Marco
Ricci, Chiara
Leoni, Alessandro
Samarani, Emanuela
Bertulli, Alice
Leali, Daria
Bernardi, Simona
Russo, Domenico
author_sort Morello, Enrico
collection PubMed
description Malnutrition is common after allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT), and interventions directed to correct nutritional status are warranted to improve transplant outcomes. In this prospective study, an oral polymeric formulation enriched with TGF-β2 (TE-OPF) was explored to correct malnutrition according to Patient-Generated Subjective Global Assessment (PG-SGA). TE-OPF was proposed to 51 consecutive patients who received transplants at our institution for hematological malignancies, and sufficient dose intake was established per protocol as at least 50% of the prescribed dose of TE-OPF: group A received adequate nutritional support; group B, inadequate. The study met the primary outcomes in terms of safety (no adverse events reported during TE-OPF intake except for its disgusting taste) and malnutrition (PG-SGA C 28 days after transplant): severely malnourished patients (PG-SGA C) accounted for 13% in group A and 88.9% in group B (p = 0.000). At the end of the study, after a median follow-up of 416 days, the estimated median Overall Survival (OS) was 734 days for well or moderately nourished patients (PG-SGA A/B) in comparison to 424 for malnourished patients (p = 0.03). Inadequate TE-OPF intake was associated with an increase in acute gastrointestinal Graft Versus Host Disease (GVHD) cumulative incidence (38% vs. 0% p = 0.006). A higher incidence of pneumonia was reported in group B (p = 0.006). IGF-1 levels at 14 and 28 days after transplant were significantly higher in group A and were associated with a lower incidence of acute GVHD (aGVHD). Higher subsets of B, T, and NK cells were found in group A, and a higher number of CD16+ NK cells was associated with a lower incidence of acute GVHD (p = 0.005) and increased survival at the end of the study (p = 0.023). Artificial neural network analysis suggested that inadequate TE-OPF intake, pneumonia, and sepsis significantly affected malnutrition 28 days after alloHSCT and survival 365 days after alloHSCT (normalized importance 100%, 82%, and 68%, respectively). In this exploratory and preliminary study, the use of TE-OPF appeared to reduce the incidence of malnutrition after alloHSCT, but larger and controlled studies are required.
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spelling pubmed-94602562022-09-10 Malnutrition Prevention after Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT): A Prospective Explorative Interventional Study with an Oral Polymeric Formulation Enriched with Transforming Growth Factor Beta 2 (TGF-β2) Morello, Enrico Arena, Francesco Malagola, Michele Farina, Mirko Polverelli, Nicola Cavagna, Elsa Colnaghi, Federica Donna, Lorenzo Zollner, Tatiana Accorsi Buttini, Eugenia Andreoli, Marco Ricci, Chiara Leoni, Alessandro Samarani, Emanuela Bertulli, Alice Leali, Daria Bernardi, Simona Russo, Domenico Nutrients Article Malnutrition is common after allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT), and interventions directed to correct nutritional status are warranted to improve transplant outcomes. In this prospective study, an oral polymeric formulation enriched with TGF-β2 (TE-OPF) was explored to correct malnutrition according to Patient-Generated Subjective Global Assessment (PG-SGA). TE-OPF was proposed to 51 consecutive patients who received transplants at our institution for hematological malignancies, and sufficient dose intake was established per protocol as at least 50% of the prescribed dose of TE-OPF: group A received adequate nutritional support; group B, inadequate. The study met the primary outcomes in terms of safety (no adverse events reported during TE-OPF intake except for its disgusting taste) and malnutrition (PG-SGA C 28 days after transplant): severely malnourished patients (PG-SGA C) accounted for 13% in group A and 88.9% in group B (p = 0.000). At the end of the study, after a median follow-up of 416 days, the estimated median Overall Survival (OS) was 734 days for well or moderately nourished patients (PG-SGA A/B) in comparison to 424 for malnourished patients (p = 0.03). Inadequate TE-OPF intake was associated with an increase in acute gastrointestinal Graft Versus Host Disease (GVHD) cumulative incidence (38% vs. 0% p = 0.006). A higher incidence of pneumonia was reported in group B (p = 0.006). IGF-1 levels at 14 and 28 days after transplant were significantly higher in group A and were associated with a lower incidence of acute GVHD (aGVHD). Higher subsets of B, T, and NK cells were found in group A, and a higher number of CD16+ NK cells was associated with a lower incidence of acute GVHD (p = 0.005) and increased survival at the end of the study (p = 0.023). Artificial neural network analysis suggested that inadequate TE-OPF intake, pneumonia, and sepsis significantly affected malnutrition 28 days after alloHSCT and survival 365 days after alloHSCT (normalized importance 100%, 82%, and 68%, respectively). In this exploratory and preliminary study, the use of TE-OPF appeared to reduce the incidence of malnutrition after alloHSCT, but larger and controlled studies are required. MDPI 2022-08-31 /pmc/articles/PMC9460256/ /pubmed/36079847 http://dx.doi.org/10.3390/nu14173589 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Morello, Enrico
Arena, Francesco
Malagola, Michele
Farina, Mirko
Polverelli, Nicola
Cavagna, Elsa
Colnaghi, Federica
Donna, Lorenzo
Zollner, Tatiana
Accorsi Buttini, Eugenia
Andreoli, Marco
Ricci, Chiara
Leoni, Alessandro
Samarani, Emanuela
Bertulli, Alice
Leali, Daria
Bernardi, Simona
Russo, Domenico
Malnutrition Prevention after Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT): A Prospective Explorative Interventional Study with an Oral Polymeric Formulation Enriched with Transforming Growth Factor Beta 2 (TGF-β2)
title Malnutrition Prevention after Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT): A Prospective Explorative Interventional Study with an Oral Polymeric Formulation Enriched with Transforming Growth Factor Beta 2 (TGF-β2)
title_full Malnutrition Prevention after Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT): A Prospective Explorative Interventional Study with an Oral Polymeric Formulation Enriched with Transforming Growth Factor Beta 2 (TGF-β2)
title_fullStr Malnutrition Prevention after Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT): A Prospective Explorative Interventional Study with an Oral Polymeric Formulation Enriched with Transforming Growth Factor Beta 2 (TGF-β2)
title_full_unstemmed Malnutrition Prevention after Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT): A Prospective Explorative Interventional Study with an Oral Polymeric Formulation Enriched with Transforming Growth Factor Beta 2 (TGF-β2)
title_short Malnutrition Prevention after Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT): A Prospective Explorative Interventional Study with an Oral Polymeric Formulation Enriched with Transforming Growth Factor Beta 2 (TGF-β2)
title_sort malnutrition prevention after allogeneic hematopoietic stem cell transplantation (allohsct): a prospective explorative interventional study with an oral polymeric formulation enriched with transforming growth factor beta 2 (tgf-β2)
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9460256/
https://www.ncbi.nlm.nih.gov/pubmed/36079847
http://dx.doi.org/10.3390/nu14173589
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