Status:
COMPLETED
Gabapentin in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Nausea and Vomiting
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Gabapentin may prevent or reduce delayed nausea and vomiting caused by chemotherapy. It is not yet known whether gabapentin is more effective than a placebo in preventing nausea and vomitin...
Detailed Description
OBJECTIVES: * To evaluate the effectiveness of gabapentin in controlling delayed chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly emetogenic chemotherapy as defined by the...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Scheduled to receive highly emetogenic chemotherapy
- May be scheduled to receive prophylactic treatment for acute nausea and vomiting with a 5HT3 antagonist and dexamethasone 20 mg on day 1 of chemotherapy treatment
- May be scheduled to receive multiple day chemotherapy regimens as long as the chemotherapy drugs given on the subsequent days have mild or no emetogenic potential
- Chemotherapy schedules must allow at least 7 days rest between courses involving administration of highly emetogenic chemotherapy
- No primary CNS malignancy and/or CNS metastasis
- PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Life expectancy ≥ 3 months
- Creatinine ≤ 1.5 times upper limit of normal within the past 30 days
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Ability to complete questionnaire(s) by his/herself or with assistance
- Able to swallow pills
- No epilepsy or seizure history
- No gastrointestinal obstruction, active peptic ulcer disease, or uncontrolled heartburn
- No history of nausea and/or vomiting related to any kind of chemotherapy
- No nausea or vomiting within the past 3 days
- No history of allergic or other adverse reaction to gabapentin or pregabalin
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior moderate or highly emetogenic chemotherapy
- No prior or concurrent aprepitant or any other NK-1 receptor antagonist
- At least 1 months since prior and no concurrent gabapentin, pregabalin, or other anticonvulsants
- At least 7 days since prior and no concurrent pelvic or abdominal radiotherapy
- At least 3 days since prior antiemetics
- No concurrent or planned use of lorazepam, diphenhydramine, eszopiclone, and/or dronabinol during the 6 days of this study, except for treatment of breakthrough nausea and vomiting
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
430 Patients enrolled
Trial Details
Trial ID
NCT00880191
Start Date
April 1 2009
End Date
May 1 2015
Last Update
July 6 2016
Active Locations (247)
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1
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
2
Aurora Presbyterian Hospital
Aurora, Colorado, United States, 80012
3
Boulder Community Hospital
Boulder, Colorado, United States, 80301-9019
4
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933