Cargando…

Randomized Study of enterade(®) to Reduce Diarrhea in Patients Receiving High-Dose Chemotherapy and Autologous Hematopoietic Stem Cell Transplantation

High-dose chemotherapy frequently causes injury to the gastrointestinal mucosa, resulting in diarrhea. The purpose of the current study was to assess the tolerability and efficacy of enterade(®) in reducing ≥ grade 2 diarrhea (G2D) in association with high-dose melphalan followed by autologous stem...

Descripción completa

Detalles Bibliográficos
Autores principales: De Filipp, Zachariah, Glotzbecker, Brett, Luque, Laura, Kim, Haesook T, Mitchell, Katherine M, Cheuvront, Samuel N, Soiffer, Robert J
Formato: Online Artículo Texto
Lenguaje:English
Publicado: West Asia Organization for Cancer Prevention 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8184175/
https://www.ncbi.nlm.nih.gov/pubmed/33507712
http://dx.doi.org/10.31557/APJCP.2021.22.1.301
_version_ 1783704536560435200
author De Filipp, Zachariah
Glotzbecker, Brett
Luque, Laura
Kim, Haesook T
Mitchell, Katherine M
Cheuvront, Samuel N
Soiffer, Robert J
author_facet De Filipp, Zachariah
Glotzbecker, Brett
Luque, Laura
Kim, Haesook T
Mitchell, Katherine M
Cheuvront, Samuel N
Soiffer, Robert J
author_sort De Filipp, Zachariah
collection PubMed
description High-dose chemotherapy frequently causes injury to the gastrointestinal mucosa, resulting in diarrhea. The purpose of the current study was to assess the tolerability and efficacy of enterade(®) in reducing ≥ grade 2 diarrhea (G2D) in association with high-dose melphalan followed by autologous stem cell transplantation (ASCT). We conducted a prospective, double blinded, multi-center trial in which 114 subjects were randomized to receive enterade(®) or placebo twice daily during the transplant hospitalization. Gastrointestinal toxicities (nausea, vomiting, oral mucositis and dysphagia) resulted in poor study compliance in both arms. Among subjects who were able to complete planned therapy (13%), the incidence of G2D was lower for those receiving enterade(®) as compared to placebo (16% vs 86%, p<0.03). Twice daily oral administration of enterade(®) and placebo following high-dose chemotherapy and ASCT was not feasible due to significant gastrointestinal toxicities. Future explorations of enterade(®) should be conducted in populations capable of reasonable oral intake.
format Online
Article
Text
id pubmed-8184175
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher West Asia Organization for Cancer Prevention
record_format MEDLINE/PubMed
spelling pubmed-81841752021-06-11 Randomized Study of enterade(®) to Reduce Diarrhea in Patients Receiving High-Dose Chemotherapy and Autologous Hematopoietic Stem Cell Transplantation De Filipp, Zachariah Glotzbecker, Brett Luque, Laura Kim, Haesook T Mitchell, Katherine M Cheuvront, Samuel N Soiffer, Robert J Asian Pac J Cancer Prev Research Article High-dose chemotherapy frequently causes injury to the gastrointestinal mucosa, resulting in diarrhea. The purpose of the current study was to assess the tolerability and efficacy of enterade(®) in reducing ≥ grade 2 diarrhea (G2D) in association with high-dose melphalan followed by autologous stem cell transplantation (ASCT). We conducted a prospective, double blinded, multi-center trial in which 114 subjects were randomized to receive enterade(®) or placebo twice daily during the transplant hospitalization. Gastrointestinal toxicities (nausea, vomiting, oral mucositis and dysphagia) resulted in poor study compliance in both arms. Among subjects who were able to complete planned therapy (13%), the incidence of G2D was lower for those receiving enterade(®) as compared to placebo (16% vs 86%, p<0.03). Twice daily oral administration of enterade(®) and placebo following high-dose chemotherapy and ASCT was not feasible due to significant gastrointestinal toxicities. Future explorations of enterade(®) should be conducted in populations capable of reasonable oral intake. West Asia Organization for Cancer Prevention 2021-01 /pmc/articles/PMC8184175/ /pubmed/33507712 http://dx.doi.org/10.31557/APJCP.2021.22.1.301 Text en https://creativecommons.org/licenses/by/3.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License, (http://creativecommons.org/licenses/by/3.0/ (https://creativecommons.org/licenses/by/3.0/) ) which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Article
De Filipp, Zachariah
Glotzbecker, Brett
Luque, Laura
Kim, Haesook T
Mitchell, Katherine M
Cheuvront, Samuel N
Soiffer, Robert J
Randomized Study of enterade(®) to Reduce Diarrhea in Patients Receiving High-Dose Chemotherapy and Autologous Hematopoietic Stem Cell Transplantation
title Randomized Study of enterade(®) to Reduce Diarrhea in Patients Receiving High-Dose Chemotherapy and Autologous Hematopoietic Stem Cell Transplantation
title_full Randomized Study of enterade(®) to Reduce Diarrhea in Patients Receiving High-Dose Chemotherapy and Autologous Hematopoietic Stem Cell Transplantation
title_fullStr Randomized Study of enterade(®) to Reduce Diarrhea in Patients Receiving High-Dose Chemotherapy and Autologous Hematopoietic Stem Cell Transplantation
title_full_unstemmed Randomized Study of enterade(®) to Reduce Diarrhea in Patients Receiving High-Dose Chemotherapy and Autologous Hematopoietic Stem Cell Transplantation
title_short Randomized Study of enterade(®) to Reduce Diarrhea in Patients Receiving High-Dose Chemotherapy and Autologous Hematopoietic Stem Cell Transplantation
title_sort randomized study of enterade(®) to reduce diarrhea in patients receiving high-dose chemotherapy and autologous hematopoietic stem cell transplantation
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8184175/
https://www.ncbi.nlm.nih.gov/pubmed/33507712
http://dx.doi.org/10.31557/APJCP.2021.22.1.301
work_keys_str_mv AT defilippzachariah randomizedstudyofenteradetoreducediarrheainpatientsreceivinghighdosechemotherapyandautologoushematopoieticstemcelltransplantation
AT glotzbeckerbrett randomizedstudyofenteradetoreducediarrheainpatientsreceivinghighdosechemotherapyandautologoushematopoieticstemcelltransplantation
AT luquelaura randomizedstudyofenteradetoreducediarrheainpatientsreceivinghighdosechemotherapyandautologoushematopoieticstemcelltransplantation
AT kimhaesookt randomizedstudyofenteradetoreducediarrheainpatientsreceivinghighdosechemotherapyandautologoushematopoieticstemcelltransplantation
AT mitchellkatherinem randomizedstudyofenteradetoreducediarrheainpatientsreceivinghighdosechemotherapyandautologoushematopoieticstemcelltransplantation
AT cheuvrontsamueln randomizedstudyofenteradetoreducediarrheainpatientsreceivinghighdosechemotherapyandautologoushematopoieticstemcelltransplantation
AT soifferrobertj randomizedstudyofenteradetoreducediarrheainpatientsreceivinghighdosechemotherapyandautologoushematopoieticstemcelltransplantation