- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01757210
A Study to Evaluate the Safety and Efficacy of Aprepitant (MK0869) for Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients
August 21, 2013 updated by: Lisa Biondo, West Virginia University Healthcare
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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West Virginia
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Morgantown, West Virginia, United States, 26506
- WVU Healthcare
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 17 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
This study will include pediatric patients with an active malignancy.
Description
Inclusion Criteria:
- 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.
Exclusion criteria:
- Pregnant or breast feeding
- Concomitant use of pimozide, terfenadine, astemizole, or cisapride
- Child-Pugh score > 9
- Receiving IV fosaprepitant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of episodes of nausea and vomiting
Time Frame: Five days after end of chemotherapy
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Appetite score on a 4-point Likert scale
Time Frame: Five days after the end of chemotherapy
|
Patients will be assessed for changes in appetite using a 4-point Likert scale at baseline, on all days of chemotherapy, and for the five days following the conclusion of chemotherapy
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Five days after the end of chemotherapy
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Activities of daily living score on a 4-point Likert scale
Time Frame: Five days after the end of chemotherapy
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Patients will be assessed for changes in activities of daily living using a 4-point Likert scale at baseline, on all days of chemotherapy, and for five days following the conclusion of chemotherapy
|
Five days after the end of chemotherapy
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Number of medications used for breakthrough nausea and vomiting
Time Frame: Five days after the end of chemotherapy
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The usage of all breakthrough medications for chemotherapy-induced nausea and vomiting while in the hospital will be recorded.
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Five days after the end of chemotherapy
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Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: Five days after the end of chemotherapy
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Incidence of adverse events that can be definitely or probably related to aprepitant using the Naranjo Adverse Event Scale.
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Five days after the end of chemotherapy
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lisa Biondo, Pharm.D., WVU Healthcare
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (ACTUAL)
August 1, 2013
Study Completion (ACTUAL)
August 1, 2013
Study Registration Dates
First Submitted
September 27, 2012
First Submitted That Met QC Criteria
December 20, 2012
First Posted (ESTIMATE)
December 28, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
August 22, 2013
Last Update Submitted That Met QC Criteria
August 21, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24267
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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