Comparison of Aprepitant vs. Gabapentin in the Prevention of Delayed Nausea and Vomiting
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.
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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.
University of New Mexico
United States: Institutional Review Board
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