Gabapentin for the prevention of chemotherapy-induced nausea and vomiting: a pilot study

被引:38
作者
Cruz, Felipe Melo [1 ]
Gomes Cubero, Daniel de Iracema [2 ]
Taranto, Patricia [2 ]
Lerner, Tatiana [2 ]
Lera, Andrea Thaumaturgo [2 ]
Miranda, Michele da Costa [2 ]
Vieira, Mariana da Cunha [2 ]
de Souza Fede, Angelo Bezerra [2 ]
Schindler, Fernanda [2 ]
Carrasco, Mercia Maleckas [2 ]
de Afonseca, Samuel Oliveira [2 ]
Pinczowski, Helio [2 ]
del Giglio, Auro [2 ]
机构
[1] Ctr, BR-09030310 Santo Andre, Brazil
[2] Fac Med ABC, Disciplina Hematol & Oncol, BR-09060650 Sao Paulo, Brazil
关键词
Antiemetics; Vomiting; Nausea; Gabapentin; Antineoplastic protocols; Prevention and control; CISPLATIN-INDUCED EMESIS; MODERATELY EMETOGENIC CHEMOTHERAPY; NEUROKININ-1 RECEPTOR ANTAGONIST; PLACEBO-CONTROLLED TRIAL; RANDOMIZED DOUBLE-BLIND; HIGH-DOSE CISPLATIN; PREOPERATIVE GABAPENTIN; OPEN CHOLECYSTECTOMY; PHASE-III; ONDANSETRON;
D O I
10.1007/s00520-011-1138-4
中图分类号
R73 [肿瘤学];
学科分类号
100214 [肿瘤学];
摘要
Introduction Chemotherapy-induced nausea and vomiting (CINV) is a distressing side effect that affects many patients undergoing emetogenic chemotherapy, despite the use of antiemetic medications. The purpose of this trial was to evaluate the efficacy and safety of gabapentin for the prevention of CINV during the first cycle of treatment in patients receiving moderately or highly emetogenic chemotherapy. Methods Eighty chemotherapy-naive patients, scheduled to receive moderately and highly emetogenic chemotherapy, were enrolled in this randomised, double-blind, placebo-controlled clinical trial. All patients received intravenous ondansetron 8 mg, dexamethasone 10 mg and ranitidine 50 mg before chemotherapy on day 1 and oral dexamethasone 4 mg twice a day on days 2 and 3. Patients were randomly assigned to take gabapentin 300 mg or placebo on the following schedule: 5 and 4 days before chemotherapy once daily, 3 and 2 days before chemotherapy twice daily, 1 day before to 5 days after chemotherapy thrice daily. The primary endpoint was complete overall protection from both vomiting and nausea over the course of the entire study (day 1 through day 5), and complete protection during the delayed period (24-120 h after chemotherapy). Results The proportion of patients achieving complete response improved from 40% to 62.5%, (p=0.04) when comparing the control group and the gabapentin group, respectively. In the subset of patients who achieved complete control in the acute phase, the percentage of patients who achieved delayed complete control was higher in the gabapentin group (89.3x60.7%, p=0.01). Adverse events did not significantly differ between study arms. Conclusions Gabapentin is a low-cost strategy to improve complete control of CINV, specially delayed CINV control.
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收藏
页码:601 / 606
页数:6
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