A Pilot Study of Aprepitant Versus Ondansetron for the Treatment of Opioid Induced Nausea and Vomiting
- To evaluate the efficacy of aprepitant as monotherapy for opioid-induced nausea and
vomiting (OINV) in comparison to ondansetron hydrochloride in patients who have failed
at least one prior anti-emetic agent/regimen.
- To determine whether control of OINV improves quality of life.
- To determine if control in OINV decreases pain.
- To determine if control in OINV improves mood.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
- Arm A: Patients receive aprepitant orally once daily for 7 days in the absence of
unacceptable toxicity or persistent grade 4 nausea and vomiting.
- Arm B: Patients receive ondansetron hydrochloride orally 3 times daily for 7 days in
the absence of unacceptable toxicity or persistent grade 4 nausea and vomiting.
Patients complete the following questionnaires: Functional Assessment of Cancer
Therapy-General (FACT-G); Center for Epidemiologic Studies Depression Scale (CES-D); and
Brief Pain Index (BPI) at baseline and on day 7. Patients also complete symptom diaries
documenting the following: number of episodes (an emetic episode is defined as a simple
vomit or retch, or any number of continuous vomits or retches; distinct episodes that are
separated by at least 1 minute) of vomiting or retching including the date and time; worst
and average degree of nausea (recorded every 2 hours while awake during the first 24 hours
after treatment and every 8 hours on days 1-7); and adverse events other than episodes of
vomiting and nausea.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Control of nausea and vomiting
Day 1 and Day 7
Barbara A. Murphy, MD
Vanderbilt-Ingram Cancer Center
United States: Food and Drug Administration
VICC SUPP 0513