Aprepitant or Ondansetron in Treating Nausea and Vomiting Caused By Opioids in Patients With Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00499668|
Recruitment Status : Withdrawn (slow accrual)
First Posted : July 11, 2007
Last Update Posted : April 2, 2013
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.
|Condition or disease||Intervention/treatment|
|Myeloproliferative Disorders Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Nausea and Vomiting Solid Tumor||Drug: aprepitant Drug: ondansetron hydrochloride|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Pilot Study of Aprepitant Versus Ondansetron for the Treatment of Opioid Induced Nausea and Vomiting|
|Study Start Date :||August 2007|
|Primary Completion Date :||January 2008|
|Study Completion Date :||March 2008|
|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
- Control of nausea and vomiting [ Time Frame: Day 1 and Day 7 ]
- Quality of life [ Time Frame: Day 1 and Day 7 ]
- Pain control [ Time Frame: Day 1 and Day 7 ]
- Mood [ Time Frame: Day 1 and Day 7 ]
- Global satisfaction [ Time Frame: Day 1 and Day 7 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00499668
|Study Chair:||Barbara A. Murphy, MD||Vanderbilt-Ingram Cancer Center|