Overview

Gabapentin in the Prevention of Nausea and Vomiting Induced by Chemotherapy

Status:
Completed
Trial end date:
2010-07-01
Target enrollment:
0
Participant gender:
All
Summary
Gabapentin is an antiepileptic drug. Its antiemetic effect is demonstrated after laparoscopic surgery, but it is not yet known whether gabapentin is effective in preventing chemotherapy induced emesis. The purpose of this study is to determine whether the addition of gabapentin to dexamethasone plus ondansetron increase the control of chemotherapy-induced nausea and vomiting.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Faculdade de Medicina do ABC
Treatments:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Gabapentin
gamma-Aminobutyric Acid
Criteria
Inclusion Criteria:

- First course of chemotherapy ( cisplatin or doxorubicin at a dose of at least 50mg per
square meter)

- Written informed consent must be obtained before initiating the protocol procedures

Exclusion Criteria:

- ECOG 3

- Nausea and vomiting within the past 1 day

- Gastrointestinal obstruction

- Concurrent use of opioid

- Patients with brain metastases

- History of allergic or other adverse reaction to gabapentin