Aprepitant or Ondansetron in Treating Nausea and Vomiting Caused By Opioids in Patients With Cancer
RATIONALE: Antiemetic drugs, such as aprepitant and ondansetron, may help lessen nausea and vomiting caused by opioids. It is not yet known whether aprepitant is more effective than ondansetron in treating nausea and vomiting caused by opioids in patients with cancer.
PURPOSE: This randomized clinical trial is studying aprepitant to see how well it works compared to ondansetron in treating nausea and vomiting caused by opioids in patients with cancer.
Multiple Myeloma and Plasma Cell Neoplasm
Nausea and Vomiting
Drug: ondansetron hydrochloride
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Pilot Study of Aprepitant Versus Ondansetron for the Treatment of Opioid Induced Nausea and Vomiting|
- Control of nausea and vomiting [ Time Frame: Day 1 and Day 7 ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: Day 1 and Day 7 ] [ Designated as safety issue: No ]
- Pain control [ Time Frame: Day 1 and Day 7 ] [ Designated as safety issue: No ]
- Mood [ Time Frame: Day 1 and Day 7 ] [ Designated as safety issue: No ]
- Global satisfaction [ Time Frame: Day 1 and Day 7 ] [ Designated as safety issue: No ]
|Study Start Date:||August 2007|
|Study Completion Date:||March 2008|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
|Experimental: ARM A||
125 mg orally for 7 days
Other Name: EMEND
|Experimental: ARM B||
Drug: ondansetron hydrochloride
24 mg orally for 7 days
Other Name: Zofran
- 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.
|Study Chair:||Barbara A. Murphy, MD||Vanderbilt-Ingram Cancer Center|