Gabapentin in the Prevention of Nausea and Vomiting Induced by Chemotherapy

ABC Foundation (FUABC)

Status and phase: Completed; Phase 3

Conditions: Cisplatin Adverse Reaction; Vomiting

Treatments: Drug: Gabapentin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01052844

ABC-2009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Gabapentin

Experimental group

Description:

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

Treatment:

Drug: Gabapentin