A Study to Evaluate the Safety and Efficacy of Aprepitant (MK0869) for Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients
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ClinicalTrials.gov Identifier: NCT01757210 |
Recruitment Status :
Completed
First Posted : December 28, 2012
Last Update Posted : August 22, 2013
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Condition or disease |
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Chemotherapy-Induced Nausea and Vomiting |
Study Type : | Observational |
Actual Enrollment : | 20 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | A Study to Evaluate the Safety and Efficacy of Aprepitant (MK0869) for Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients |
Study Start Date : | September 2012 |
Actual Primary Completion Date : | August 2013 |
Actual Study Completion Date : | August 2013 |

- 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
- 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
- Activities of daily living score on a 4-point Likert scale [ Time Frame: Five days after the end of chemotherapy ]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
- Number of medications used for breakthrough nausea and vomiting [ Time Frame: Five days after the end of chemotherapy ]The usage of all breakthrough medications for chemotherapy-induced nausea and vomiting while in the hospital will be recorded.
- Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Five days after the end of chemotherapy ]Incidence of adverse events that can be definitely or probably related to aprepitant using the Naranjo Adverse Event Scale.

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Ages Eligible for Study: | 1 Year to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01757210
United States, West Virginia | |
WVU Healthcare | |
Morgantown, West Virginia, United States, 26506 |
Principal Investigator: | Lisa Biondo, Pharm.D. | WVU Healthcare |
Other Publications:
Responsible Party: | Lisa Biondo, Pharm.D., BCPS, West Virginia University Healthcare |
ClinicalTrials.gov Identifier: | NCT01757210 |
Other Study ID Numbers: |
24267 |
First Posted: | December 28, 2012 Key Record Dates |
Last Update Posted: | August 22, 2013 |
Last Verified: | August 2013 |
Aprepitant Pediatrics Chemotherapy-induced nausea/vomiting Survey |
Nausea Vomiting Signs and Symptoms, Digestive |