Abstract
Nausea and vomiting are major inconveniences for patients undergoing chemotherapy. Despite standard preventive treatment, chemotherapy-induced nausea and vomiting (CINV) still occurs in approximately 50% of these patients. In an attempt to optimize this treatment, we evaluated the possible effects of carbamazepine for prevention of CINV. Prospective nonrandomized open-label phase II study carried out at a Brazilian public oncology service. Patients allocated for their first cycle of highly emetogenic chemotherapy were continuously recruited. In addition to standard antiemetic protocol that was made available, they received carbamazepine orally, with staggered doses, from the third day before until the fifth day after chemotherapy. Considering the sparseness of evidence about the efficacy of anticonvulsants for CINV prevention, we used Simon's two-stage design, in which 43 patients should be included unless overall complete prevention was not achieved in 9 out of the first 15 entries. The Functional Living Index-Emesis questionnaire was used to measure the impact on quality of life. None of the ten patients (0%) presented overall complete prevention. In three cases, carbamazepine therapy was withdrawn because of somnolence and vomiting before chemotherapy. Seven were able to take the medication for the entire period and none were responsive, so the study was closed. There was no impact on the patients' quality of life. Carbamazepine was not effective for prevention of CINV and also had a deleterious side-effect profile in this population.
Highlights
Nausea and vomiting are major inconveniences for patients undergoing cancer therapy
Several factors have been implicated in development of chemotherapy-induced nausea and vomiting (CINV), i.e. the intrinsic emetogenicity of some chemotherapeutic agents, either alone or in combination.[2,4,5]
All patients received the standard antiemetic treatment that was available, which was based on intravenous ondansetron (8 mg), dexamethasone (10 mg) and ranitidine (50 mg) before chemotherapy infusion, followed by oral dexamethasone (4 mg), twice a day on days 2 and 3
Summary
Nausea and vomiting are major inconveniences for patients undergoing cancer therapy. Several factors have been implicated in development of chemotherapy-induced nausea and vomiting (CINV), i.e. the intrinsic emetogenicity of some chemotherapeutic agents, either alone or in combination.[2,4,5] CINV is classified according to the timing of the occurrence: acute — occurs and resolves within the first 24 hours after chemotherapy; or delayed — occurs after the first 24 hours after chemotherapy administration.[5,6] Because of the severity of the acute phase, this has been more often targeted in therapeutic intervention studies. The symptoms in the delayed period are less marked than those observed in acutely started nausea and vomiting, its course can be more protracted, resulting in poor hydration and nutrition control, in addition to poor performance status.[7,8]
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