Gabapentin in the Prevention of Nausea and Vomiting Induced by Chemotherapy

Phase 3

Completed

• Conditions: Vomiting; Cisplatin Adverse Reaction
• Interventions: Drug: Placebo; Drug: Gabapentin

• Registration Number: NCT01052844
• Lead Sponsor: Faculdade de Medicina do ABC

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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-12-17
• Study First Submitted QC: 2010-01-19
• Study First Posted: 2010-01-20
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Results First Submitted: 2010-09-24
• Status Verified: 2014-01
• Results First Submitted QC: 2014-01-18
• Last Update Submitted: 2014-01-18
• Results First Posted: 2014-03-07
• Last Update Posted: 2014-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Placebo	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
Gabapentin	Gabapentin	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

Primary Outcome Measures

Name	Time	Method
Number of Patients With Complete Response During Chemotherapy Course 1	5 days	The CR was defined as no emetic episodes and no nausea episodes from day 1 to day 5 (0-120h)
Number of Patients With CR During Delayed-onset Phase (24-120 Hours) After Administration of Chemotherapy Course 1	6 days	Complete response during delayed-onset phase was defined as the absence of any episode of nausea or vomiting and no use of rescue medication when occurring during the period from days 2 through 5 after chemotherapy

Trial Locations

Locations (1)

Faculdade de Medicina do ABC; 🇧🇷 Santo André, São Paulo, Brazil