Gabapentin in the Prevention of Nausea and Vomiting Induced by Chemotherapy

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

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.

Intervention(s) in this Clinical Trial

• Drug: Placebo
  • Placebo, given orally
• Drug: Gabapentin
  • Gabapentin 300mg, orally

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Control group
  • Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1) Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy 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
• Experimental: Gabapentin
  • Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1) Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy 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 Measures

• Proportional of patients with complete response (CR) during chemotherapy course 1 (0-120h). The CR will be defined as no emetic episodes and no nausea episodes.
  • Time Frame: 6 days
    Safety Issue?: Yes
• Proportion of patients with CR during acute phase (0-24 hours) after administration of chemotherapy course 1
  • Time Frame: 1 day
    Safety Issue?: Yes
• Proportion of patients with CR during delayed-onset phase (24-120 hours) after administration of chemotherapy course 1
  • Time Frame: 6 days
    Safety Issue?: Yes

Secondary Measures

• Quality of life and the impact of nausea and vomiting on day 6 with the nausea subscale on the Functional Living Index-emesis questionnaire
  • Time Frame: 6 days
    Safety Issue?: No
• Time to treatment failure based on time to first emetic episode or time to first use of rescue medication
  • Time Frame: 5 days
    Safety Issue?: No
• Severity of nausea daily and during chemotherapy course 1 (0-120 hours)
  • Time Frame: 5 days
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Faculdade de Medicina do ABC Other

Overall Clinical Trial Officials and Contacts

Auro del Giglio, phD Study Director Faculdade de Medicina do ABC  

Overall Contact: Felipe M Cruz 551181388214 felipemcruz@yahoo.com.br

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01052844

Study ID Number: ABC-2009

ClinicalTrials.gov Identifier: NCT01052844

Health Authority: Brazil: National Committee of Ethics in Research