A Study to Evaluate the Safety and Efficacy of Aprepitant (MK0869) for Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients
| Status: | Completed |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 1 - 17 |
| Updated: | 11/30/-0001 |
| Start Date: | September 2012 |
| End Date: | November 2013 |
| Contact: | Lisa Biondo, Pharm.D. |
| Email: | biondol@wvuhealthcare.com |
| Phone: | 304-598-4148 |
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.
This will be a prospective, observational study conducted at WVU Children´s Hospital. The
study will be conducted over a one—year period until data from 20—40 patient encounters is
obtained. There will be no randomization and no control group. Information will be collected
from all patients who meet the study´s inclusion criteria. Patients will be given a survey
to complete at baseline, on all days of chemotherapy, and for five days after the conclusion
of chemotherapy using the BARF Scale and a 4—point Likert scale. The information collected
from the survey will include the incidence and severity of nausea and emesis, evaluation of
appetite, activities of daily living, and rescue medications used for acute CINV. The
specific chemotherapy regimen that each patient receives will be recorded. Any data
identifying the patient will be de—identified after all pertinent data is collected.
Descriptive statistics will be used to analyze data.
Inclusion Criteria:
1. Patient is between the ages of 1-17 years
2. Patient has a confirmed malignancy
3. Patient is receiving highly or moderately emetogenic chemotherapy
4. Receiving aprepitant as part of an anti-emetic regimen
5. 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.
6. 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.
Exclusion criteria:
1. Pregnant or breast feeding
2. Concomitant use of pimozide, terfenadine, astemizole, or cisapride
3. Child-Pugh score > 9
4. Receiving IV fosaprepitant
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