Clinical trial NCT01757210: A Study to Evaluate the Safety and Efficacy of Aprepitant (MK0869) for Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients
Official title: A Study to Evaluate the Safety and Efficacy of Aprepitant (MK0869) for Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chemotherapy-Induced Nausea and Vomiting
Keywords: Aprepitant
Pediatrics
Chemotherapy-induced nausea/vomiting
Survey
Lead sponsor: West Virginia University Healthcare
Sponsor class: OTHER
First posted: 2012-12-28
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will include pediatric patients with an active malignancy.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of episodes of nausea and vomiting
timeFrame: Five days after end of chemotherapy
Secondary outcomes:
measure: Appetite score on a 4-point Likert scale
timeFrame: Five days after the end of chemotherapy
measure: Activities of daily living score on a 4-point Likert scale
timeFrame: Five days after the end of chemotherapy
measure: Number of medications used for breakthrough nausea and vomiting
timeFrame: Five days after the end of chemotherapy
measure: Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Five days after the end of chemotherapy
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: WVU Healthcare
state: West Virginia
Study officials:
affiliation: WVU Healthcare
name: Lisa Biondo, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith AR, Repka TL, Weigel BJ. Aprepitant for the control of chemotherapy induced nausea and vomiting in adolescents. Pediatr Blood Cancer. 2005 Nov;45(6):857-60. doi: 10.1002/pbc.20378.
citation: Choi MR, Jiles C, Seibel NL. Aprepitant use in children, adolescents, and young adults for the control of chemotherapy-induced nausea and vomiting (CINV). J Pediatr Hematol Oncol. 2010 Oct;32(7):e268-71. doi: 10.1097/MPH.0b013e3181e5e1af.
citation: Gore L, Chawla S, Petrilli A, Hemenway M, Schissel D, Chua V, Carides AD, Taylor A, Devandry S, Valentine J, Evans JK, Oxenius B; Adolescent Aprepitant in Cancer Study Group. Aprepitant in adolescent patients for prevention of chemotherapy-induced nausea and vomiting: a randomized, double-blind, placebo-controlled study of efficacy and tolerability. Pediatr Blood Cancer. 2009 Feb;52(2):242-7. doi: 10.1002/pbc.21811.