A Study to Evaluate the Safety and Efficacy of Aprepitant (MK0869) for Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients
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.
Observational Model: Case-Only, Time Perspective: Prospective
Number of episodes of nausea and vomiting
The primary outcome measure is assessing the incidence of chemotherapy-induced nausea and vomiting in pediatric patients receiving highly or moderately emetogenic chemotherapy and a prophylactic regimen that includes aprepitant. The incidence of chemotherapy-induced nausea and vomiting will be evaluated using the BARF Scale and a 4-point Likert scale on all days of chemotherapy and for five days following the conclusion of chemotherapy compared to baseline
Five days after end of chemotherapy
Lisa Biondo, Pharm.D.
United States: Institutional Review Board
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