Gabapentin in the Prevention of Nausea and Vomiting Induced by Chemotherapy

Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01052844
• Other study ID #: ABC-2009
• Status: Completed
• Phase: Phase 3
• First received: December 17, 2009
• Last updated: January 18, 2014
• Start date: January 2009
• Est. completion date: July 2010

Study information

• Verified date: January 2014
• Source: Faculdade de Medicina do ABC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cisplatin Adverse Reaction
• Vomiting

Intervention

Drug:
• 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)
• 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)

Locations

Country	Name	City	State
Brazil	Faculdade de Medicina do ABC	Santo André	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Faculdade de Medicina do ABC

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes