Phase 3
N=80
Gabapentin in the Prevention of Nausea and Vomiting Induced by Chemotherapy
Vomiting · Cisplatin Adverse Reaction
Bottom Line
View on ClinicalTrials.gov: NCT01052844 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Number of Patients With Complete Response During Chemotherapy Course 1 — 17; 26 participants — p=0.04
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); Gabapentin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Faculdade de Medicina do ABC
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Complete Response During Chemotherapy Course 1 |
17; 26 | 0.04 sig |
| PRIMARY Number of Patients With CR During Delayed-onset Phase (24-120 Hours) After Administration of Chemotherapy Course 1 |
21; 29 | 0.06 |
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.
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
Data sourced from ClinicalTrials.gov (NCT01052844). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.