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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
Sponsor:
Information provided by (Responsible Party):
Lisa Biondo, West Virginia University Healthcare

Tracking Information
First Submitted Date September 27, 2012
First Posted Date December 28, 2012
Last Update Posted Date August 22, 2013
Study Start Date September 2012
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 20, 2012)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 20, 2012)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population This study will include pediatric patients with an active malignancy.
Condition Chemotherapy-Induced Nausea and Vomiting
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 21, 2013)
20
Original Estimated Enrollment
 (submitted: December 20, 2012)
40
Actual Study Completion Date August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Year to 17 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01757210
Other Study ID Numbers 24267
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Lisa Biondo, West Virginia University Healthcare
Study Sponsor West Virginia University Healthcare
Collaborators Not Provided
Investigators
Principal Investigator: Lisa Biondo, Pharm.D. WVU Healthcare
PRS Account West Virginia University Healthcare
Verification Date August 2013