Carbamazepine for prevention of chemotherapy-induced nausea and vomiting: a pilot study.
OBJECTIVE
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.


METHODS
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.


RESULTS
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 In three cases, carbamazepine therapy was withdrawn because of somnolence and vomiting before chemotherapy.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.


CONCLUSIONS
Carbamazepine was not effective for prevention of CINV and also had a deleterious side-effect profile in this population.
Faculdade de Medicina do ABC, São Paulo, Brazil.
Thaiana Aragão
TA
Santana
Faculdade de Medicina do ABC, São Paulo, Brazil.
Felipe Melo
FM
Cruz
Faculdade de Medicina do ABC, São Paulo, Brazil.
Damila Cristina
DC
Trufelli
Instituto do Câncer do Estado de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.
João
J
Glasberg
Faculdade de Medicina do ABC, São Paulo, Brazil.
Auro
A
Del Giglio
D000932:Antiemetics / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects*; D002220:Carbamazepine / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000188:drug therapy / Q000517:prevention & control*; D009369:Neoplasms / Q000188:drug therapy; D010865:Pilot Projects; D011446:Prospective Studies; D011788:Quality of Life; D012893:Sleep Wake Disorders / Q000139:chemically induced; D014839:Vomiting / Q000139:chemically induced / Q000188:drug therapy / Q000517:prevention & control*
D000932:Antiemetics; D000970:Antineoplastic Agents; D002220:Carbamazepine