Gabapentin in the Prevention of Nausea and Vomiting Induced by Chemotherapy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Vomiting Cisplatin Adverse Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Control group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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)

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

Group Type EXPERIMENTAL

Gabapentin

Intervention Type DRUG

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)

Interventions

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Placebo

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 Type DRUG

Gabapentin

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)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No