Comparison of Aprepitant Versus Gabapentin in the Prevention of Delayed Nausea and Vomiting
- To compare the effectiveness of gabapentin (titrated to300mg TID days -2 to 5) with aprepitant (125mg on day 1 and 80mg on days 2 and 3) in the control of delayed nausea and vomiting associated with level 3, 4 or 5 emetogenic chemotherapy in patients who experienced delayed nausea and/or vomiting during their first cycle of chemotherapy.
- To evaluate and compare the safety profile associated with each anti-emetic regimen.
- To assess subject satisfaction with anti-emetic therapy.
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Comparison of Aprepitant vs. Gabapentin in the Prevention of Delayed Nausea and Vomiting|
- To compare the effectiveness of gabapentin with aprepitant in the control of delayed nausea & vomiting associated with level 3, 4 or 5 emetogenic chemotherapy in pts who experienced delayed nausea and/or vomiting during their first cycle of chemotherapy. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2004|
|Study Completion Date:||September 2007|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
|Experimental: Arm A||
Drug: Aprepitant vs. Gabapentin
Gabapentin 300mg PO QHS day -2; 300mg PO BID day -1; 300mg PO TID days 0 through +5.
|Active Comparator: Arm B||
Drug: Aprepitant vs. Gabapentin
Aprepitant 125mg PO 60 minutes prior to chemotherapy on day 0; 80 mg PO QAM on days +1 and +2.
The purpose of study is to compare the effectiveness of aprepitant and gabapentin in treating "delayed" (days later) nausea and/or vomiting for patients receiving chemotherapy treatment for cancer. Patients on the study will receive aprepitant or gabapentin in addition to the standard medications used to prevent nausea and vomiting. Aprepitant is approved by the FDA for nausea and vomiting. Gabapentin is approved by the FDA for the treatment of seizures but it may be effective in controlling nausea and vomiting due to chemotherapy. Subjects receiving aprepitant will be receiving a proven treatment for delayed nausea and vomiting, while subjects receiving gabapentin will be receiving a drug that has only shown limited effectiveness.
Patients are eligible for participation in this study because they are going to receive chemotherapy that may cause nausea or vomiting. If patients have delayed nausea or vomiting after the first cycle of treatment, they will be offered a chance to receive additional treatments with their second cycle of chemotherapy. The University of New Mexico Health Sciences Center is sponsoring the study.
The first 40 patients enrolled in the study will participate in the pilot phase of the study. A pilot study is a smaller version of a full study to determine how effective the treatments are. All 40 patients in the pilot phase of the study will come from UNM. If the pilot phase is found to be successful, then the study will continue and approximately 200 patients will eventually be enrolled. The full study will be conducted at the University of New Mexico Cancer Research and Treatment Center (UNM CRTC), the New Mexico VA Healthcare System, and at members of the New Mexico Cancer Care Alliance.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00250744
|United States, New Mexico|
|University of New Mexico|
|Albuquerque, New Mexico, United States, 87131|
|Principal Investigator:||Stanley Cheshire||University of New Mexico|