A Study to Evaluate the Safety and Efficacy of Aprepitant (MK0869) for Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients

Completed

Conditions studied: Chemotherapy-Induced Nausea and Vomiting

In brief

Aprepitant was approved in 2003. The drug works to lessen the amount of nausea and vomiting that cancer patients experience after treatment. Aprepitant has been well-studied in adults, but not in children. Data from adult studies has shown aprepitant to be safe. It has also been shown to be effective in lessening the amount of nausea and vomiting that adult patients experience. Because aprepitant has been shown to be safe and effective, the investigators have been using it in pediatric patients at this hospital as standard of care. The investigators will be surveying patients already receiving aprepitant for prevention of chemotherapy-induced nausea and vomiting to determine the amount of nausea and vomiting they experience. The investigators will also be surveying these patients to determine what their appetite is like and if they experience any disruptions in activities of daily living. The investigators are also going to be assessing any side effects these patients experience from receiving aprepitant.

Key facts

Study ID

NCT01757210

Run by

West Virginia University Healthcare

People needed

20

Starts

2012-09-01

Expected to finish

2013-08-01

Last updated by the study team

2013-08-22

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is between the ages of 1-17 years
• Patient has a confirmed malignancy
• Patient is receiving highly or moderately emetogenic chemotherapy
• Receiving aprepitant as part of an anti-emetic regimen
• Patient's legally-authorized representative understands and voluntarily signs the written informed consent prior to any study-specific procedures. A copy of the signed informed consent form will be retained by the treating institution.
• Patient ≥7 years of age understands and voluntarily signs the written informed assent form prior to any study specific procedures. A copy of the signed informed assent form will be retained by the treating institution.

You may not qualify if…

• Pregnant or breast feeding
• Concomitant use of pimozide, terfenadine, astemizole, or cisapride
• Child-Pugh score > 9
• Receiving IV fosaprepitant

Where it is running

• WVU Healthcare — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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