Conditions: Vomiting Cisplatin Adverse Reaction
Keywords: Vomiting Antiemetics Dexamethasone Cisplatin Antineoplastic combined chemotherapy protocols
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 80
Healthy volunteers: no

Brief 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.

Detailed description:
This was a prospective, double-blind, placebo-controlled study conducted at our institution (Faculdade de Medicina da Fundação ABC and affiliated Hospitals) from April 2009 to April 2010. Patients and personnel involved in the study were blinded to the assigned treatment. The study was approved by the ethics committee of our institution. All the patients provided written informed consent.

Arms:
arm 1: Placebo:

* Five and four days before chemotherapy (day -5 and day -4): 1x daily
* Three and two days before chemotherapy (day -3 and day -2): 2x daily
* One day before to five days after chemotherapy ( day -1 to day 5): 3x daily arm 2: Gabapentin 300mg:

* Five and four days before chemotherapy (day -5 and day -4): 1x daily
* Three and two days before chemotherapy (day -3 and day -2): 2x daily
* One day before to five days after chemotherapy ( day -1 to day 5): 3x daily

Interventions: intervention 1: Placebo intervention 2: Gabapentin
Intervention descriptions: intervention 1: Placebo, given orally Ranitide 50 mg, IV, before chemotherapy (D1) Ondansetron 8 mg, IV, before chemotherapy (D1) Dexamethasone 10 mg, IV, before chemotherapy (D1) Dexamethasone 4 mg, PO, 2x/day (D2, D3) intervention 2: Gabapentin 300mg, orally Ranitide 50 mg, IV, before chemotherapy (D1) Ondansetron 8 mg, IV, before chemotherapy (D1) Dexamethasone 10 mg, IV, before chemotherapy (D1) Dexamethasone 4 mg, PO, 2x/day (D2, D3)

Protocol document: