Phase II study of pregabalin for the prevention of chemotherapy induced nausea and vomiting

To evaluate the role of pregabalin in the protection of chemotherapy-induced nausea and vomiting, we performed a phase II randomized, double-blind, placebo-controlled trial to investigate whether pregabalin could improve the complete control of nausea and vomiting (primary end point). We enrolled 82...

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Authors: Paniquar, Carla Santos Rossi, del Giglio, Auro, Yamada, Alayne Magalhães Trindade Domingues, Cruz, Felipe José Silva Melo
Format: article
Status:Published version
Publication Date:2024
Country:Brasil
Institution:Centro Universitário São Camilo
Repository:O Mundo da Saúde (Online)
Language:Portuguese
English
OAI Identifier:oai:ojs3.revistamundodasaude.emnuvens.com.br:article/1540
Online Access:https://revistamundodasaude.emnuvens.com.br/mundodasaude/article/view/1540
Access Level:Open access
Keyword:Nausea
Neurokinin-1 receptor antagonists
Pregabalin
Antiemetics
Cancer
Náuseas
Antagonistas do receptor da Neurocinina-1
Pregabalina
Antieméticos
Câncer
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spelling Phase II study of pregabalin for the prevention of chemotherapy induced nausea and vomitingEstudo de fase II de pregabalina para prevenção de náuseas e vômitos induzidos por quimioterapiaNauseaNeurokinin-1 receptor antagonistsPregabalinAntiemeticsCancerNáuseasAntagonistas do receptor da Neurocinina-1PregabalinaAntieméticosCâncerTo evaluate the role of pregabalin in the protection of chemotherapy-induced nausea and vomiting, we performed a phase II randomized, double-blind, placebo-controlled trial to investigate whether pregabalin could improve the complete control of nausea and vomiting (primary end point). We enrolled 82 chemotherapy-naive patients, scheduled to receive moderately and highly emetogenic chemotherapy. All patients received IV ondansetron 8mg, dexamethasone 10mg before chemotherapy on day one and oral dexamethasone 4mg, b.d., on days two and three. Patients were randomly assigned to take pregabalin 75mg or placebo, bd, from the night before chemotherapy to day five. The overall complete response was not statistically significant between the groups (53.7 versus 48.8%, respectively, in the pregabalin group and the control group (P=0.65)). There was also no significant difference during the acute phase (first 24 hours) and delayed phase (24-120h): 80.5% versus 82.9% (P=0.77), 53.7 versus 51.2% (P=0.82), respectively. There is no role for pregabalin preventing chemotherapy-induced nausea and vomiting. Clinicaltrial.gov registration number: NCT04181346.Para avaliar o papel da pregabalina na proteção das náuseas e vômitos induzidos pela quimioterapia, foi realizado um ensaio clínico de fase II, aleatorizado, duplamente cego, controlado por placebo, para investigar se a pregabalina poderia melhorar o controle completo das náuseas e vômitos (desfecho primário). Inscrevemos 82 pacientes virgens de quimioterapia, programados para receber quimioterapia moderadamente e altamente emetogênica. Todos os doentes receberam ondansetron 8mg por via intravenosa, dexametasona 10mg antes da quimioterapia no primeiro dia e, dexametasona 4 mg por via oral, b.d., nos dias dois e três. Os doentes foram distribuídos aleatoriamente para tomar pregabalina 75 mg ou placebo, bd, desde a noite anterior à quimioterapia até ao quinto dia. A resposta completa global não foi estatisticamente significativa entre os grupos (53,7 versus 48,8%, respetivamente, no grupo da pregabalina e no grupo de controlo (P=0,65)). Também não houve diferença estatística significativa durante a fase aguda (primeiras 24 horas) e a fase tardia (24-120h): 80,5% versus 82,9% (P=0,77), 53,7 versus 51,2% (P=0,82), respectivamente. Neste estudo não foi identificada ação da pregabalina na prevenção de náuseas e vômitos induzidos por quimioterapia. Número de registo no Clinicaltrial.gov: NCT04181346.Centro Universitário São Camilo2024-03-11info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttps://revistamundodasaude.emnuvens.com.br/mundodasaude/article/view/154010.15343/0104-7809.202448e15402023PO Mundo da Saúde; Vol. 48 (2024): O Mundo da SaúdeO Mundo da Saúde; Vol. 48 (2024): O Mundo da SaúdeO Mundo da Saúde; v. 48 (2024): O Mundo da Saúde1980-39900104-7809reponame:O Mundo da Saúde (Online)instname:Centro Universitário São Camiloinstacron:SAOCAMILOporenghttps://revistamundodasaude.emnuvens.com.br/mundodasaude/article/view/1540/1430https://revistamundodasaude.emnuvens.com.br/mundodasaude/article/view/1540/1431Copyright (c) 2024 O Mundo da Saúdeinfo:eu-repo/semantics/openAccessPaniquar, Carla Santos Rossi del Giglio, AuroYamada, Alayne Magalhães Trindade DominguesCruz, Felipe José Silva Melo2025-02-12T16:42:08Zoai:ojs3.revistamundodasaude.emnuvens.com.br:article/1540Revistahttps://revistamundodasaude.emnuvens.com.br/mundodasaude/indexPRIhttps://revistamundodasaude.emnuvens.com.br/mundodasaude/oamundodasaude@saocamilo-sp.br || secretariapublica@saocamilo-sp.brhttps://doi.org/10.15343/0104-78091980-39900104-7809opendoar:2025-02-12T16:42:08O Mundo da Saúde (Online) - Centro Universitário São Camilofalse
dc.title.none.fl_str_mv Phase II study of pregabalin for the prevention of chemotherapy induced nausea and vomiting
Estudo de fase II de pregabalina para prevenção de náuseas e vômitos induzidos por quimioterapia
title Phase II study of pregabalin for the prevention of chemotherapy induced nausea and vomiting
spellingShingle Phase II study of pregabalin for the prevention of chemotherapy induced nausea and vomiting
Paniquar, Carla Santos Rossi
Nausea
Neurokinin-1 receptor antagonists
Pregabalin
Antiemetics
Cancer
Náuseas
Antagonistas do receptor da Neurocinina-1
Pregabalina
Antieméticos
Câncer
title_short Phase II study of pregabalin for the prevention of chemotherapy induced nausea and vomiting
title_full Phase II study of pregabalin for the prevention of chemotherapy induced nausea and vomiting
title_fullStr Phase II study of pregabalin for the prevention of chemotherapy induced nausea and vomiting
title_full_unstemmed Phase II study of pregabalin for the prevention of chemotherapy induced nausea and vomiting
title_sort Phase II study of pregabalin for the prevention of chemotherapy induced nausea and vomiting
dc.creator.none.fl_str_mv Paniquar, Carla Santos Rossi
del Giglio, Auro
Yamada, Alayne Magalhães Trindade Domingues
Cruz, Felipe José Silva Melo
author Paniquar, Carla Santos Rossi
author_facet Paniquar, Carla Santos Rossi
del Giglio, Auro
Yamada, Alayne Magalhães Trindade Domingues
Cruz, Felipe José Silva Melo
author_role author
author2 del Giglio, Auro
Yamada, Alayne Magalhães Trindade Domingues
Cruz, Felipe José Silva Melo
author2_role author
author
author
dc.subject.por.fl_str_mv Nausea
Neurokinin-1 receptor antagonists
Pregabalin
Antiemetics
Cancer
Náuseas
Antagonistas do receptor da Neurocinina-1
Pregabalina
Antieméticos
Câncer
topic Nausea
Neurokinin-1 receptor antagonists
Pregabalin
Antiemetics
Cancer
Náuseas
Antagonistas do receptor da Neurocinina-1
Pregabalina
Antieméticos
Câncer
description To evaluate the role of pregabalin in the protection of chemotherapy-induced nausea and vomiting, we performed a phase II randomized, double-blind, placebo-controlled trial to investigate whether pregabalin could improve the complete control of nausea and vomiting (primary end point). We enrolled 82 chemotherapy-naive patients, scheduled to receive moderately and highly emetogenic chemotherapy. All patients received IV ondansetron 8mg, dexamethasone 10mg before chemotherapy on day one and oral dexamethasone 4mg, b.d., on days two and three. Patients were randomly assigned to take pregabalin 75mg or placebo, bd, from the night before chemotherapy to day five. The overall complete response was not statistically significant between the groups (53.7 versus 48.8%, respectively, in the pregabalin group and the control group (P=0.65)). There was also no significant difference during the acute phase (first 24 hours) and delayed phase (24-120h): 80.5% versus 82.9% (P=0.77), 53.7 versus 51.2% (P=0.82), respectively. There is no role for pregabalin preventing chemotherapy-induced nausea and vomiting. Clinicaltrial.gov registration number: NCT04181346.
publishDate 2024
dc.date.none.fl_str_mv 2024-03-11
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://revistamundodasaude.emnuvens.com.br/mundodasaude/article/view/1540
10.15343/0104-7809.202448e15402023P
url https://revistamundodasaude.emnuvens.com.br/mundodasaude/article/view/1540
identifier_str_mv 10.15343/0104-7809.202448e15402023P
dc.language.iso.fl_str_mv por
eng
language por
eng
dc.relation.none.fl_str_mv https://revistamundodasaude.emnuvens.com.br/mundodasaude/article/view/1540/1430
https://revistamundodasaude.emnuvens.com.br/mundodasaude/article/view/1540/1431
dc.rights.driver.fl_str_mv Copyright (c) 2024 O Mundo da Saúde
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Copyright (c) 2024 O Mundo da Saúde
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Centro Universitário São Camilo
publisher.none.fl_str_mv Centro Universitário São Camilo
dc.source.none.fl_str_mv O Mundo da Saúde; Vol. 48 (2024): O Mundo da Saúde
O Mundo da Saúde; Vol. 48 (2024): O Mundo da Saúde
O Mundo da Saúde; v. 48 (2024): O Mundo da Saúde
1980-3990
0104-7809
reponame:O Mundo da Saúde (Online)
instname:Centro Universitário São Camilo
instacron:SAOCAMILO
instname_str Centro Universitário São Camilo
instacron_str SAOCAMILO
institution SAOCAMILO
reponame_str O Mundo da Saúde (Online)
collection O Mundo da Saúde (Online)
repository.name.fl_str_mv O Mundo da Saúde (Online) - Centro Universitário São Camilo
repository.mail.fl_str_mv mundodasaude@saocamilo-sp.br || secretariapublica@saocamilo-sp.br
_version_ 1853663492494589952
score 15,228081

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