Gabapentin in the Prevention of Nausea and Vomiting Induced by Chemotherapy | RxWiki

Gabapentin in the Prevention of Nausea and Vomiting Induced by Chemotherapy

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Vomiting Cisplatin Adverse Reaction
Intervention	Drug: Placebo Drug: Gabapentin
Phase	Phase 3
Sponsor	Faculdade de Medicina do ABC
Responsible Party	Faculdade de Medicina do ABC
ClinicalTrials.gov Identifier	NCT01052844
First Received	December 17, 2009
Last Updated	January 18, 2014
Last verified	January 2014

Tracking Information[ + expand ][ + ]

First Received Date	December 17, 2009
Last Updated Date	January 18, 2014
Start Date	January 2009
Estimated Primary Completion Date	July 2010
Current Primary Outcome Measures	Number of Patients With Complete Response During Chemotherapy Course 1 [Time Frame: 5 days] [Designated as safety issue: Yes]The CR was defined as no emetic episodes and no nausea episodes from day 1 to day 5 (0-120h) Number of Patients With CR During Delayed-onset Phase (24-120 Hours) After Administration of Chemotherapy Course 1 [Time Frame: 6 days] [Designated as safety issue: Yes]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
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	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
Brief 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.
Detailed 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.
Study Type	Interventional
Study Phase	Phase 3
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Condition	Vomiting Cisplatin Adverse Reaction
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) 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)
Study Arm (s)	Placebo Comparator: 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 Experimental: 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

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	80
Estimated Completion Date	July 2010
Estimated Primary Completion Date	July 2010
Eligibility Criteria	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	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Brazil

Administrative Information[ + expand ][ + ]

NCT Number	NCT01052844
Other Study ID Numbers	ABC-2009
Has Data Monitoring Committee	Yes
Information Provided By	Faculdade de Medicina do ABC
Study Sponsor	Faculdade de Medicina do ABC
Collaborators	Not Provided
Investigators	Study Director: Auro del Giglio, phD Faculdade de Medicina do ABC
Verification Date	January 2014

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