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


N/A
1 Year
17 Years
Open (Enrolling)
Both
Chemotherapy-Induced Nausea and Vomiting

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Trial Information

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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Number of episodes of nausea and vomiting

Outcome Description:

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

Outcome Time Frame:

Five days after end of chemotherapy

Safety Issue:

No

Principal Investigator

Lisa Biondo, Pharm.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

WVU Healthcare

Authority:

United States: Institutional Review Board

Study ID:

24267

NCT ID:

NCT01757210

Start Date:

September 2012

Completion Date:

November 2013

Related Keywords:

  • Chemotherapy-Induced Nausea and Vomiting
  • Aprepitant
  • Pediatrics
  • Chemotherapy-induced nausea/vomiting
  • Survey
  • Nausea
  • Vomiting

Name

Location
WVU Healthcare Morgantown, West Virginia  26506