PHASE II STUDY TO EVALUATE EFFICACY AND SAFETY OF CARBAMAZEPINE FOR THE PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING.
Meanwhile there are a lot of studies with these three classes of drugs, some efforts are
being done to reach higher control rates of CINV with different drugs. In this scenario, in
a randomized phase II placebo-controlled trial Cruz et. al. demonstrated that Gabapentin
raises chemotherapy-induced nausea and vomiting control when associated with Dexametason and
Ondasetron, suggesting that it could be a cost-effective alternative to neurokinin 1
receptor antagonists9, although, as we know, there aren`t comparative studies with
gabapentin and aprepitant. Guttuso et al demonstrated in an open clinical study the
antiemetic effect of gabapentin in chemotherapy-induced acute (within 24hs) and delayed
onset (days 2-5) nausea and vomiting in breast cancer patients with refractory emesis10.
Tan e cols showed higher complete and delayed nausea and vomiting control rates for
olanzapine vs. aprepitant, in association with palonosetron and dexametason in highly and
moderately emetogenic potential chemotherapy11. Navari e cols haven't found similar results
although this comparison may not be done, since maintenance anti-emetic treatment was
different between these studies12.
In a case report, Strohscheer I. & Borasio GD showed complete control of refractory nausea
and vomiting in one patient with meningeal carcinomatosis treated with Carbamazepine13.
Carbamazepine is an available anticonvulsant largely used in Brazil. The aim of this study
is to evaluate the role of Carbamazepine for the prevention of nausea and vomiting induced
by moderate and highly emetogenic chemotherapy.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Efficacy of Carbamazepine
To evaluate complete protection (CP) of chemotherapy induced nausea and vomiting, defined as the percentage of patients without nausea or vomiting and the absence of use of rescue medication.
Brazil: Ethics Committee