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...
| Autores: | , , , |
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| Tipo de recurso: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2024 |
| País: | Brasil |
| Institución: | Centro Universitário São Camilo |
| Repositorio: | O Mundo da Saúde (Online) |
| Idioma: | portugués inglés |
| OAI Identifier: | oai:ojs3.revistamundodasaude.emnuvens.com.br:article/1540 |
| Acceso en línea: | https://revistamundodasaude.emnuvens.com.br/mundodasaude/article/view/1540 |
| Access Level: | acceso abierto |
| Palabra clave: | Nausea Neurokinin-1 receptor antagonists Pregabalin Antiemetics Cancer Náuseas Antagonistas do receptor da Neurocinina-1 Pregabalina Antieméticos Câncer |
| Sumario: | 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. |
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