Gabapentin in the Prevention of Nausea and Vomiting Induced by Chemotherapy

Study Overview
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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.

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.

Official Title
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Clinical Trial of Gabapentin in the Prevention of Nausea Ond Vomiting Induced by Chemotherapy, a Randomized, Double-blind, Placebo Controled Study

Conditions
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Vomiting, Cisplatin Adverse Reaction

Intervention / Treatment
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* Drug: Placebo
* Drug: Gabapentin


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>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 | Drug: Placebo<br>* 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)<br>|
| Experimental: Gabapentin<br>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 | Drug: Gabapentin<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Complete Response During Chemotherapy Course 1 | The CR was defined as no emetic episodes and no nausea episodes from day 1 to day 5 (0-120h) | 5 days | 
| Number of Patients With CR During Delayed-onset Phase (24-120 Hours) After Administration of Chemotherapy Course 1 | 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 | 6 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vomiting, Antiemetics, Dexamethasone, Cisplatin, Antineoplastic combined chemotherapy protocols