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Lactobacillus brevis CD2 lozenges prevent oral mucositis in patients undergoing high dose chemotherapy followed by haematopoietic stem cell transplantation

BACKGROUND: Oral mucositis is a common inflammatory complication in patients undergoing high-dose chemotherapy and radiation followed by haematopoietic stem cell transplantation (HSCT). Lactobacillus brevis CD2 has been proven efficacious in preventing chemoradiotherapy-induced oral mucositis in squ...

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Autores principales: Sharma, Atul, Tilak, TVSVGK, Bakhshi, Sameer, Raina, Vinod, Kumar, Lalit, Chaudhary, Surendra Pal, Sahoo, Ranjit Kumar, Gupta, Ritu, Thulkar, Sanjay
Formato: Online Artículo Texto
Lenguaje:English
Publicado: ESMO Open 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5548970/
https://www.ncbi.nlm.nih.gov/pubmed/28848667
http://dx.doi.org/10.1136/esmoopen-2016-000138
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author Sharma, Atul
Tilak, TVSVGK
Bakhshi, Sameer
Raina, Vinod
Kumar, Lalit
Chaudhary, Surendra Pal
Sahoo, Ranjit Kumar
Gupta, Ritu
Thulkar, Sanjay
author_facet Sharma, Atul
Tilak, TVSVGK
Bakhshi, Sameer
Raina, Vinod
Kumar, Lalit
Chaudhary, Surendra Pal
Sahoo, Ranjit Kumar
Gupta, Ritu
Thulkar, Sanjay
author_sort Sharma, Atul
collection PubMed
description BACKGROUND: Oral mucositis is a common inflammatory complication in patients undergoing high-dose chemotherapy and radiation followed by haematopoietic stem cell transplantation (HSCT). Lactobacillus brevis CD2 has been proven efficacious in preventing chemoradiotherapy-induced oral mucositis in squamous cell carcinoma of head and neck. METHODS: This phase II study aimed to evaluate the safety and efficacy of L. brevis CD2 lozenges in preventing oral mucositis in patients undergoing HSCT. Eligible patients received four to six lozenges of L. brevis CD2 per day, beginning from 4 to 7 days before initiation of chemotherapy and continuing until resolution of mucositis or till day +24. RESULTS: Of 31 patients enrolled, 7 (22.6%) patients did not develop any mucositis, 6 (19.4%) patients developed grade 1, 12 (38.7%) patients developed grade 2, 4 (12.9%) and 2 (6.5%) patients developed grade 3 and grade 4 mucositis, respectively. Median time to onset and for resolution of mucositis were 6 days and 8 days, respectively. No adverse events were reported with usage of study drug. However, one patient died of Klebsiella sepsis. CONCLUSION: Promising results from the study encourage the use of L. brevis CD2 lozenges as a supportive care treatment option; however, a randomised, double-blind, multicentric trial in a larger population is warranted. TRIALS REGISTRATION NUMBER: NCT01480011 at https://www.clinicaltrials.gov/ (Registered on Nov 04, 2011).
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spelling pubmed-55489702017-08-28 Lactobacillus brevis CD2 lozenges prevent oral mucositis in patients undergoing high dose chemotherapy followed by haematopoietic stem cell transplantation Sharma, Atul Tilak, TVSVGK Bakhshi, Sameer Raina, Vinod Kumar, Lalit Chaudhary, Surendra Pal Sahoo, Ranjit Kumar Gupta, Ritu Thulkar, Sanjay ESMO Open Original Research BACKGROUND: Oral mucositis is a common inflammatory complication in patients undergoing high-dose chemotherapy and radiation followed by haematopoietic stem cell transplantation (HSCT). Lactobacillus brevis CD2 has been proven efficacious in preventing chemoradiotherapy-induced oral mucositis in squamous cell carcinoma of head and neck. METHODS: This phase II study aimed to evaluate the safety and efficacy of L. brevis CD2 lozenges in preventing oral mucositis in patients undergoing HSCT. Eligible patients received four to six lozenges of L. brevis CD2 per day, beginning from 4 to 7 days before initiation of chemotherapy and continuing until resolution of mucositis or till day +24. RESULTS: Of 31 patients enrolled, 7 (22.6%) patients did not develop any mucositis, 6 (19.4%) patients developed grade 1, 12 (38.7%) patients developed grade 2, 4 (12.9%) and 2 (6.5%) patients developed grade 3 and grade 4 mucositis, respectively. Median time to onset and for resolution of mucositis were 6 days and 8 days, respectively. No adverse events were reported with usage of study drug. However, one patient died of Klebsiella sepsis. CONCLUSION: Promising results from the study encourage the use of L. brevis CD2 lozenges as a supportive care treatment option; however, a randomised, double-blind, multicentric trial in a larger population is warranted. TRIALS REGISTRATION NUMBER: NCT01480011 at https://www.clinicaltrials.gov/ (Registered on Nov 04, 2011). ESMO Open 2017-02-13 /pmc/articles/PMC5548970/ /pubmed/28848667 http://dx.doi.org/10.1136/esmoopen-2016-000138 Text en © European Society for Medical Oncology (unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
spellingShingle Original Research
Sharma, Atul
Tilak, TVSVGK
Bakhshi, Sameer
Raina, Vinod
Kumar, Lalit
Chaudhary, Surendra Pal
Sahoo, Ranjit Kumar
Gupta, Ritu
Thulkar, Sanjay
Lactobacillus brevis CD2 lozenges prevent oral mucositis in patients undergoing high dose chemotherapy followed by haematopoietic stem cell transplantation
title Lactobacillus brevis CD2 lozenges prevent oral mucositis in patients undergoing high dose chemotherapy followed by haematopoietic stem cell transplantation
title_full Lactobacillus brevis CD2 lozenges prevent oral mucositis in patients undergoing high dose chemotherapy followed by haematopoietic stem cell transplantation
title_fullStr Lactobacillus brevis CD2 lozenges prevent oral mucositis in patients undergoing high dose chemotherapy followed by haematopoietic stem cell transplantation
title_full_unstemmed Lactobacillus brevis CD2 lozenges prevent oral mucositis in patients undergoing high dose chemotherapy followed by haematopoietic stem cell transplantation
title_short Lactobacillus brevis CD2 lozenges prevent oral mucositis in patients undergoing high dose chemotherapy followed by haematopoietic stem cell transplantation
title_sort lactobacillus brevis cd2 lozenges prevent oral mucositis in patients undergoing high dose chemotherapy followed by haematopoietic stem cell transplantation
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5548970/
https://www.ncbi.nlm.nih.gov/pubmed/28848667
http://dx.doi.org/10.1136/esmoopen-2016-000138
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